Document ID: FDA-2017-N-1129-0001
Agency: fda
Document Type: Notice
Title: Medical Devices: Exemptions From Premarket Notification; Class II Devices; Request for Comments
Posted Date: 2017-03-14T04:00Z

[Federal Register Volume 82, Number 48 (Tuesday, March 14, 2017)]
[Notices]
[Pages 13609-13632]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-04938]

-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-N-1129]

Medical Devices; Exemptions From Premarket Notification: Class II 
Devices; Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; request for comments.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA or Agency) has 
identified a list of class II devices that, when finalized, will be 
exempt from premarket notification requirements, subject to certain 
limitations. FDA is publishing this notice of that determination and 
requesting public comment in accordance with procedures established by 
the 21st

[[Page 13610]]

Century Cures Act. This notice does not represent FDA's final 
determination with respect to the class II devices included in this 
document. FDA will review any comments submitted within the 60-day 
comment period and will consider whether the list of class II devices 
should be modified prior to publication of its final determination in 
the Federal Register.

DATES: Submit either electronic or written comments on the notice by 
May 15, 2017. Late, untimely filed comments will not be considered. 
Electronic comments must be submitted on or before May 15, 2017. The 
https://www.regulations.gov electronic filing system will accept 
comments until midnight Eastern Time at the end of May 15, 2017. 
Comments received by mail/hand delivery/courier (for written/paper 
submissions) will be considered timely if they are postmarked or the 
delivery service acceptance receipt is on or before that date.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper 
submissions): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of 
Dockets Management, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2017-N-1129 for ``Medical Devices; Exemptions from Premarket 
Notification: Class II Devices.'' Received comments, those filed in a 
timely manner (see DATES), will be placed in the docket and, except for 
those submitted as ``Confidential Submissions,'' publicly viewable at 
https://www.regulations.gov or at the Division of Dockets Management 
between 9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on https://www.regulations.gov. 
Submit both copies to the Division of Dockets Management. If you do not 
wish your name and contact information to be made publicly available, 
you can provide this information on the cover sheet and not in the body 
of your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Division of Dockets Management, 5630 Fishers 
Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Bryce Bennett, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 5244, Silver Spring, MD 20993, 301-348-1446, email: 
Gregory.Bennett@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: 

I. Background

    Under section 513 of the Federal Food, Drug, and Cosmetic Act (the 
FD&C Act) (21 U.S.C. 360c), FDA must classify devices into one of three 
regulatory classes: Class I, class II, or class III. FDA classification 
of a device is determined by the amount of regulation necessary to 
provide a reasonable assurance of safety and effectiveness. Under the 
Medical Device Amendments of 1976 (1976 amendments) (Pub. L. 94-295), 
and the amendments of the Safe Medical Devices Act of 1990 (Pub. L. 
101-629), devices are to be classified into class I (general controls) 
if there is information showing that the general controls of the FD&C 
Act are sufficient to assure safety and effectiveness; into class II 
(special controls), if general controls, by themselves, are 
insufficient to provide reasonable assurance of safety and 
effectiveness, but there is sufficient information to establish special 
controls to provide such assurance; and into class III (premarket 
approval), if there is insufficient information to support classifying 
a device into class I or class II and the device is a life sustaining 
or life supporting device or is for a use which is of substantial 
importance in preventing impairment of human health or presents a 
potential unreasonable risk of illness or injury.
    Most generic types of devices that were on the market before the 
date of the 1976 amendments (May 28, 1976) (generally referred to as 
preamendments devices) have been classified by FDA under the procedures 
set forth in section 513(c) and (d) of the FD&C Act through the 
issuance of classification regulations into one of these three 
regulatory classes. Devices introduced into interstate commerce for the 
first time on or after May 28, 1976 (generally referred to as 
postamendments devices) are classified through the premarket 
notification process under section 510(k) of the FD&C Act (21 U.S.C. 
360(k)). Section 510(k) of the FD&C Act and the implementing 
regulations, part 807 of Title 21 of the Code of Federal Regulations 
(CFR), require persons who intend to market a new device to submit a 
premarket notification (510(k))

[[Page 13611]]

containing information that allows FDA to determine whether the new 
device is ``substantially equivalent'' within the meaning of section 
513(i) of the FD&C Act to a legally marketed device that does not 
require premarket approval.
    On December 13, 2016, the President signed into law the 21st 
Century Cures Act (Pub. L. 114-255). Section 3054 of the 21st Century 
Cures Act amended section 510(m) of the FD&C Act. As amended, section 
510(m)(1)(A) of the FD&C Act requires FDA to publish in the Federal 
Register a notice containing a list of each type of class II device 
that FDA determines no longer requires a report under section 510(k) of 
the FD&C Act to provide reasonable assurance of safety and 
effectiveness. FDA is required to publish this notice within 90 days of 
the date of enactment of the 21st Century Cures Act and at least once 
every 5 years thereafter, as FDA determines appropriate. Additionally, 
FDA must provide at least a 60-day comment period for any such notice 
required to be published under section 510(m)(1)(A) of the FD&C Act. 
Within 210 days of enactment of the 21st Century Cures Act, FDA must 
publish in the Federal Register a list representing its final 
determination regarding the exemption of the devices that were 
contained in the present list published under section 510(m)(1)(A) of 
the FD&C Act. Section 510(m)(3) of the FD&C Act provides that upon the 
date of publication of the final list in the Federal Register, a 510(k) 
will no longer be required for these devices and the classification 
regulation applicable to each such type of device shall be deemed 
amended to incorporate such exemption.
    In a final action, and after considering comments, FDA intends to 
amend the codified language for each listed regulation to reflect the 
final determination with respect to exempt devices. FDA's final action 
will decrease regulatory burdens on the medical device industry and 
will eliminate private costs and expenditures required to comply with 
Federal regulation. Specifically, regulated industry will no longer 
have to invest time and resources in 510(k) notifications, including 
preparation of documents and data for submission to FDA, payment of 
user fees associated with 510(k) submissions, and responding to 
questions and requests for additional information from FDA during 
510(k) review.

II. Criteria for Exemption

    There are a number of factors FDA may consider to determine whether 
a 510(k) is necessary to provide reasonable assurance of the safety and 
effectiveness of a class II device. These factors are discussed in the 
guidance the Agency issued on February 19, 1998, entitled ``Procedures 
for Class II Device Exemptions from Premarket Notification, Guidance 
for Industry and CDRH Staff'' (Ref. 1).

III. Limitations on Exemptions

    FDA believes that the types of class II devices listed in this 
notice should be exempt from the premarket notification requirements 
found under section 510(k) of the FD&C Act. However, an exemption from 
the requirement of premarket notification does not mean that the device 
is exempt from any other statutory or regulatory requirements, unless 
such exemption is explicitly provided by order or regulation. FDA's 
initial determination that premarket notification is unnecessary to 
provide a reasonable assurance of safety and effectiveness for devices 
listed in this document is based, in part, on the assurance of safety 
and effectiveness that other regulatory controls, such as current good 
manufacturing practice requirements, provide.
    In addition to being subject to the general limitations to the 
exemptions found in Sec. Sec.  862.9 to 892.9) 21 CFR 862.9 to 892.9, 
FDA may partially limit the exemption from premarket notification 
requirements to specific devices within a listed device type. In table 
1, for example, FDA is listing the exemption of the endoscopic magnetic 
retriever, but limits the exemption to such devices that are for single 
use. All other endoscopic magnetic retrievers are still subject to 
premarket notification requirements because FDA determined that 
premarket notification is necessary to provide a reasonable assurance 
of safety and effectiveness for these devices.

IV. List of Class II Devices

    FDA is identifying the following list of class II devices that, if 
finalized, would no longer require premarket notification under section 
510(k) of the FD&C Act, subject to the general limitations to the 
exemptions found in Sec. Sec.  862.9 to 892.9:

                        Table 1--Class II Devices
------------------------------------------------------------------------
                                                      Partial exemption
    21 CFR section       Device type      Product      limitation (if
                                           code          applicable)
------------------------------------------------------------------------
862.1020.............  Acid             CJN         ....................
                        Phosphatase,
                        Nitrophenylpho
                        sphate.
862.1020.............  Acid             CJR         ....................
                        Phosphatase,
                        Thymol Blue
                        Monophosphate.
862.1020.............  Acid             CJX         ....................
                        Phosphatase,
                        Disodium
                        Phenylphosphat
                        e.
862.1020.............  Acid             CKB         ....................
                        Phosphatase,
                        Naphthyl
                        Phosphate.
862.1020.............  Acid             CKE         ....................
                        Phosphatase,
                        Thymolphthale
                        Inmonophosphat
                        e.
862.1020.............  Acid             CKH         ....................
                        Phosphatase,
                        Beta
                        Glycerophospha
                        te.
862.1020.............  Acid             JFH         ....................
                        Phosphatase
                        (Prostatic),
                        Tartrate
                        Inhibited.
862.1090.............  Radioassay,      KQN         ....................
                        Angiotensin
                        Converting
                        Enzyme.
862.1100.............  Vanillin         CIF         ....................
                        Pyruvate, AST/
                        SGOT.
862.1100.............  Diazo, AST/SGOT  CIQ         ....................
862.1100.............  Hydrazone        CIS         ....................
                        Colorimetry,
                        AST/SGOT.
862.1100.............  NADH Oxidation/  CIT         ....................
                        NAD Reduction,
                        AST/SGOT.
862.1150.............  Calibrator,      JIS         ....................
                        Primary.
862.1150.............  Calibrator,      JIT         ....................
                        Secondary.

[[Page 13612]]

 
862.1150.............  Calibrator,      JIW         ....................
                        Surrogate.
862.1150.............  Calibrator,      JIX         ....................
                        Multi-Analyte
                        Mixture.
862.1345.............  Drink, Glucose   MRV         ....................
                        Tolerance.
862.1350.............  Continuous       PJT         ....................
                        Glucose
                        Monitor
                        Secondary
                        Display.
862.1445.............  Chromatographic  CEX         ....................
                        Separation,
                        Lactate
                        Dehydrogenase
                        Isoenzymes.
862.1445.............  Electrophoretic  CFE         ....................
                        , Lactate
                        Dehydrogenase
                        Isoenzymes.
862.1445.............  Differential     JGF         ....................
                        Rate Kinetic
                        Method,
                        Lactate
                        Dehydrogenase
                        Isoenzymes.
862.1509.............  System, Test,    LPT         ....................
                        Urinary
                        Methylmalonic
                        Acid.
862.1685.............  Radioimmunoassa  CEE         ....................
                        y, Thyroxine-
                        Binding
                        Globulin.
862.1700.............  Radioimmunoassa  CDX         ....................
                        y, Total
                        Thyroxine.
862.1700.............  Enzyme           KLI         ....................
                        Immunoassay,
                        Non-
                        Radiolabeled,
                        Total
                        Thyroxine.
862.2265.............  High Throughput  PFF         ....................
                        DNA Sequence
                        Analyzer.
862.2570.............  Instrumentation  NSU         ....................
                        For Clinical
                        Multiplex Test
                        Systems.
862.2570.............  Real Time        OOI         ....................
                        Nucleic Acid
                        Amplification
                        System.
862.2570.............  Mass             OTA         ....................
                        Spectrometer
                        For Clinical
                        Multiplex Test
                        Systems.
862.2570.............  Micro Total      OUE         ....................
                        Analysis
                        Instrument
                        System.
862.2570.............  Complete Gene    OVA         ....................
                        Expression
                        Profiling
                        Accessory
                        Reagents.
862.2570.............  DNA Genetic      PCA         ....................
                        Analyzer.
862.2570.............  Data             PQQ         ....................
                        Acquisition
                        Software.
862.3100.............  Enzyme           DKZ         Exemption is limited
                        Immunoassay,                 to test systems
                        Amphetamine.                 intended for
                                                     employment and
                                                     insurance testing
                                                     and does not
                                                     include test
                                                     systems intended
                                                     for Federal drug
                                                     testing programs
                                                     (e.g., programs run
                                                     by the Substance
                                                     Abuse and Mental
                                                     Health Services
                                                     Administration
                                                     (SAMHSA), the
                                                     Department of
                                                     Transportation
                                                     (DOT), and the U.S.
                                                     military.).
862.3100.............  Radioimmunoassa  DJP         Exemption is limited
                        y, Amphetamine.              to test systems
                                                     intended for
                                                     employment and
                                                     insurance testing
                                                     and does not
                                                     include test
                                                     systems intended
                                                     for Federal drug
                                                     testing programs
                                                     (e.g., programs run
                                                     by the Substance
                                                     Abuse and Mental
                                                     Health Services
                                                     Administration
                                                     (SAMHSA), the
                                                     Department of
                                                     Transportation
                                                     (DOT), and the U.S.
                                                     military.).
862.3100.............  Thin Layer       DIT         Exemption is limited
                        Chromatography               to test systems
                        , Amphetamine.               intended for
                                                     employment and
                                                     insurance testing
                                                     and does not
                                                     include test
                                                     systems intended
                                                     for Federal drug
                                                     testing programs
                                                     (e.g., programs run
                                                     by the Substance
                                                     Abuse and Mental
                                                     Health Services
                                                     Administration
                                                     (SAMHSA), the
                                                     Department of
                                                     Transportation
                                                     (DOT), and the U.S.
                                                     military.).
862.3100.............  Gas              DOD         Exemption is limited
                        Chromatography               to test systems
                        , Amphetamine.               intended for
                                                     employment and
                                                     insurance testing
                                                     and does not
                                                     include test
                                                     systems intended
                                                     for Federal drug
                                                     testing programs
                                                     (e.g., programs run
                                                     by the Substance
                                                     Abuse and Mental
                                                     Health Services
                                                     Administration
                                                     (SAMHSA), the
                                                     Department of
                                                     Transportation
                                                     (DOT), and the U.S.
                                                     military.).
862.3100.............  Liquid           DNI         Exemption is limited
                        Chromatography               to test systems
                        , Amphetamine.               intended for
                                                     employment and
                                                     insurance testing
                                                     and does not
                                                     include test
                                                     systems intended
                                                     for Federal drug
                                                     testing programs
                                                     (e.g., programs run
                                                     by the Substance
                                                     Abuse and Mental
                                                     Health Services
                                                     Administration
                                                     (SAMHSA), the
                                                     Department of
                                                     Transportation
                                                     (DOT), and the U.S.
                                                     military.).
862.3150.............  Enzyme           DJL         Exemption is limited
                        Immunoassay,                 to test systems
                        Barbiturate.                 intended for
                                                     employment and
                                                     insurance testing
                                                     and does not
                                                     include test
                                                     systems intended
                                                     for Federal drug
                                                     testing programs
                                                     (e.g., programs run
                                                     by the Substance
                                                     Abuse and Mental
                                                     Health Services
                                                     Administration
                                                     (SAMHSA), the
                                                     Department of
                                                     Transportation
                                                     (DOT), and the U.S.
                                                     military.).
862.3150.............  Enzyme           DIS         Exemption is limited
                        Immunoassay,                 to test systems
                        Barbiturate.                 intended for
                                                     employment and
                                                     insurance testing
                                                     and does not
                                                     include test
                                                     systems intended
                                                     for Federal drug
                                                     testing programs
                                                     (e.g., programs run
                                                     by the Substance
                                                     Abuse and Mental
                                                     Health Services
                                                     Administration
                                                     (SAMHSA), the
                                                     Department of
                                                     Transportation
                                                     (DOT), and the U.S.
                                                     military.).

[[Page 13613]]

 
862.3150.............  Radioimmunoassa  DKN         Exemption is limited
                        y, Barbiturate.              to test systems
                                                     intended for
                                                     employment and
                                                     insurance testing
                                                     and does not
                                                     include test
                                                     systems intended
                                                     for Federal drug
                                                     testing programs
                                                     (e.g., programs run
                                                     by the Substance
                                                     Abuse and Mental
                                                     Health Services
                                                     Administration
                                                     (SAMHSA), the
                                                     Department of
                                                     Transportation
                                                     (DOT), and the U.S.
                                                     military.).
862.3150.............  Thin Layer       DKX         Exemption is limited
                        Chromatography               to test systems
                        , Barbiturate.               intended for
                                                     employment and
                                                     insurance testing
                                                     and does not
                                                     include test
                                                     systems intended
                                                     for Federal drug
                                                     testing programs
                                                     (e.g., programs run
                                                     by the Substance
                                                     Abuse and Mental
                                                     Health Services
                                                     Administration
                                                     (SAMHSA), the
                                                     Department of
                                                     Transportation
                                                     (DOT), and the U.S.
                                                     military.).
862.3150.............  Mercury          DJN         Exemption is limited
                        Dithiazone,                  to test systems
                        Colorimetry,                 intended for
                        Barbiturate.                 employment and
                                                     insurance testing
                                                     and does not
                                                     include test
                                                     systems intended
                                                     for Federal drug
                                                     testing programs
                                                     (e.g., programs run
                                                     by the Substance
                                                     Abuse and Mental
                                                     Health Services
                                                     Administration
                                                     (SAMHSA), the
                                                     Department of
                                                     Transportation
                                                     (DOT), and the U.S.
                                                     military.).
862.3150.............  Hemagglutinatio  DLX         Exemption is limited
                        n Inhibition,                to test systems
                        Barbiturate.                 intended for
                                                     employment and
                                                     insurance testing
                                                     and does not
                                                     include test
                                                     systems intended
                                                     for Federal drug
                                                     testing programs
                                                     (e.g., programs run
                                                     by the Substance
                                                     Abuse and Mental
                                                     Health Services
                                                     Administration
                                                     (SAMHSA), the
                                                     Department of
                                                     Transportation
                                                     (DOT), and the U.S.
                                                     military.).
862.3150.............  Gas Liquid       DMF         Exemption is limited
                        Chromatography               to test systems
                        , Barbiturate.               intended for
                                                     employment and
                                                     insurance testing
                                                     and does not
                                                     include test
                                                     systems intended
                                                     for Federal drug
                                                     testing programs
                                                     (e.g., programs run
                                                     by the Substance
                                                     Abuse and Mental
                                                     Health Services
                                                     Administration
                                                     (SAMHSA), the
                                                     Department of
                                                     Transportation
                                                     (DOT), and the U.S.
                                                     military.).
862.3150.............  High Pressure    KZY         Exemption is limited
                        Liquid                       to test systems
                        Chromatography               intended for
                        , Barbiturate.               employment and
                                                     insurance testing
                                                     and does not
                                                     include test
                                                     systems intended
                                                     for Federal drug
                                                     testing programs
                                                     (e.g., programs run
                                                     by the Substance
                                                     Abuse and Mental
                                                     Health Services
                                                     Administration
                                                     (SAMHSA), the
                                                     Department of
                                                     Transportation
                                                     (DOT), and the U.S.
                                                     military.).
862.3170.............  Enzyme           JXM         Exemption is limited
                        Immunoassay,                 to test systems
                        Benzodiazepine.              intended for
                                                     employment and
                                                     insurance testing
                                                     and does not
                                                     include test
                                                     systems intended
                                                     for Federal drug
                                                     testing programs
                                                     (e.g., programs run
                                                     by the Substance
                                                     Abuse and Mental
                                                     Health Services
                                                     Administration
                                                     (SAMHSA), the
                                                     Department of
                                                     Transportation
                                                     (DOT), and the U.S.
                                                     military.).
862.3170.............  High Pressure    LAA         Exemption is limited
                        Liquid                       to test systems
                        Chromatography               intended for
                        ,                            employment and
                        Benzodiazepine.              insurance testing
                                                     and does not
                                                     include test
                                                     systems intended
                                                     for Federal drug
                                                     testing programs
                                                     (e.g., programs run
                                                     by the Substance
                                                     Abuse and Mental
                                                     Health Services
                                                     Administration
                                                     (SAMHSA), the
                                                     Department of
                                                     Transportation
                                                     (DOT), and the U.S.
                                                     military.).
862.3170.............  Test,            NFV         Exemption is limited
                        Benzodiazepine               to test systems
                        , Over The                   intended for
                        Counter.                     employment and
                                                     insurance testing
                                                     and does not
                                                     include test
                                                     systems intended
                                                     for Federal drug
                                                     testing programs
                                                     (e.g., programs run
                                                     by the Substance
                                                     Abuse and Mental
                                                     Health Services
                                                     Administration
                                                     (SAMHSA), the
                                                     Department of
                                                     Transportation
                                                     (DOT), and the U.S.
                                                     military.).
862.3170.............  Gas              KZZ         Exemption is limited
                        Chromatography               to test systems
                        ,                            intended for
                        Benzodiazepine.              employment and
                                                     insurance testing
                                                     and does not
                                                     include test
                                                     systems intended
                                                     for Federal drug
                                                     testing programs
                                                     (e.g., programs run
                                                     by the Substance
                                                     Abuse and Mental
                                                     Health Services
                                                     Administration
                                                     (SAMHSA), the
                                                     Department of
                                                     Transportation
                                                     (DOT), and the U.S.
                                                     military.).
862.3170.............  Thin Layer       LAB         Exemption is limited
                        Chromatography               to test systems
                        ,                            intended for
                        Benzodiazepine.              employment and
                                                     insurance testing
                                                     and does not
                                                     include test
                                                     systems intended
                                                     for Federal drug
                                                     testing programs
                                                     (e.g., programs run
                                                     by the Substance
                                                     Abuse and Mental
                                                     Health Services
                                                     Administration
                                                     (SAMHSA), the
                                                     Department of
                                                     Transportation
                                                     (DOT), and the U.S.
                                                     military.).
862.3200.............  Calibrators,     DKB         ....................
                        Drug Mixture.
862.3200.............  Calibrators,     DLJ         ....................
                        Drug Specific.
862.3200.............  Calibrators,     DNN         ....................
                        Ethyl Alcohol.
862.3250.............  Enzyme           DIO         Exemption is limited
                        Immunoassay,                 to test systems
                        Cocaine and                  intended for
                        Cocaine                      employment and
                        Metabolites.                 insurance testing
                                                     and does not
                                                     include test
                                                     systems intended
                                                     for Federal drug
                                                     testing programs
                                                     (e.g., programs run
                                                     by the Substance
                                                     Abuse and Mental
                                                     Health Services
                                                     Administration
                                                     (SAMHSA), the
                                                     Department of
                                                     Transportation
                                                     (DOT), and the U.S.
                                                     military.).
862.3250.............  Radioimmunoassa  KLN         Exemption is limited
                        y, Cocaine                   to test systems
                        Metabolite.                  intended for
                                                     employment and
                                                     insurance testing
                                                     and does not
                                                     include test
                                                     systems intended
                                                     for Federal drug
                                                     testing programs
                                                     (e.g., programs run
                                                     by the Substance
                                                     Abuse and Mental
                                                     Health Services
                                                     Administration
                                                     (SAMHSA), the
                                                     Department of
                                                     Transportation
                                                     (DOT), and the U.S.
                                                     military.).

[[Page 13614]]

 
862.3250.............  Enzyme           JXO         Exemption is limited
                        Immunoassay,                 to test systems
                        Cocaine.                     intended for
                                                     employment and
                                                     insurance testing
                                                     and does not
                                                     include test
                                                     systems intended
                                                     for Federal drug
                                                     testing programs
                                                     (e.g., programs run
                                                     by the Substance
                                                     Abuse and Mental
                                                     Health Services
                                                     Administration
                                                     (SAMHSA), the
                                                     Department of
                                                     Transportation
                                                     (DOT), and the U.S.
                                                     military.).
862.3250.............  Hemagglutinatio  DLN         Exemption is limited
                        n, Cocaine                   to test systems
                        Metabolites                  intended for
                        (Benzoylecgoni               employment and
                        ne).                         insurance testing
                                                     and does not
                                                     include test
                                                     systems intended
                                                     for Federal drug
                                                     testing programs
                                                     (e.g., programs run
                                                     by the Substance
                                                     Abuse and Mental
                                                     Health Services
                                                     Administration
                                                     (SAMHSA), the
                                                     Department of
                                                     Transportation
                                                     (DOT), and the U.S.
                                                     military.).
862.3250.............  Thin Layer       DMN         Exemption is limited
                        Chromatography               to test systems
                        , Cocaine.                   intended for
                                                     employment and
                                                     insurance testing
                                                     and does not
                                                     include test
                                                     systems intended
                                                     for Federal drug
                                                     testing programs
                                                     (e.g., programs run
                                                     by the Substance
                                                     Abuse and Mental
                                                     Health Services
                                                     Administration
                                                     (SAMHSA), the
                                                     Department of
                                                     Transportation
                                                     (DOT), and the U.S.
                                                     military.).
862.3250.............  Free Radical     DIR         Exemption is limited
                        Assay, Cocaine.              to test systems
                                                     intended for
                                                     employment and
                                                     insurance testing
                                                     and does not
                                                     include test
                                                     systems intended
                                                     for Federal drug
                                                     testing programs
                                                     (e.g., programs run
                                                     by the Substance
                                                     Abuse and Mental
                                                     Health Services
                                                     Administration
                                                     (SAMHSA), the
                                                     Department of
                                                     Transportation
                                                     (DOT), and the U.S.
                                                     military.).
862.3250.............  Gas              DIN         Exemption is limited
                        Chromatography               to test systems
                        , Cocaine.                   intended for
                                                     employment and
                                                     insurance testing
                                                     and does not
                                                     include test
                                                     systems intended
                                                     for Federal drug
                                                     testing programs
                                                     (e.g., programs run
                                                     by the Substance
                                                     Abuse and Mental
                                                     Health Services
                                                     Administration
                                                     (SAMHSA), the
                                                     Department of
                                                     Transportation
                                                     (DOT), and the U.S.
                                                     military.).
862.3250.............  Thin Layer       DOM         Exemption is limited
                        Chromatography               to test systems
                        ,                            intended for
                        Benzoylecgonin               employment and
                        e.                           insurance testing
                                                     and does not
                                                     include test
                                                     systems intended
                                                     for Federal drug
                                                     testing programs
                                                     (e.g., programs run
                                                     by the Substance
                                                     Abuse and Mental
                                                     Health Services
                                                     Administration
                                                     (SAMHSA), the
                                                     Department of
                                                     Transportation
                                                     (DOT), and the U.S.
                                                     military.).
862.3250.............  High Pressure    LAC         Exemption is limited
                        Liquid                       to test systems
                        Chromatography               intended for
                        , Cocaine and                employment and
                        Cocaine                      insurance testing
                        Metabolites.                 and does not
                                                     include test
                                                     systems intended
                                                     for Federal drug
                                                     testing programs
                                                     (e.g., programs run
                                                     by the Substance
                                                     Abuse and Mental
                                                     Health Services
                                                     Administration
                                                     (SAMHSA), the
                                                     Department of
                                                     Transportation
                                                     (DOT), and the U.S.
                                                     military.).
862.3270.............  High Pressure    LAE         Exemption is limited
                        Liquid                       to test systems
                        Chromatography               intended for
                        , Codeine.                   employment and
                                                     insurance testing
                                                     and does not
                                                     include test
                                                     systems intended
                                                     for Federal drug
                                                     testing programs
                                                     (e.g., programs run
                                                     by the Substance
                                                     Abuse and Mental
                                                     Health Services
                                                     Administration
                                                     (SAMHSA), the
                                                     Department of
                                                     Transportation
                                                     (DOT), and the U.S.
                                                     military.).
862.3270.............  Thin Layer       DLD         Exemption is limited
                        Chromatography               to test systems
                        , Codeine.                   intended for
                                                     employment and
                                                     insurance testing
                                                     and does not
                                                     include test
                                                     systems intended
                                                     for Federal drug
                                                     testing programs
                                                     (e.g., programs run
                                                     by the Substance
                                                     Abuse and Mental
                                                     Health Services
                                                     Administration
                                                     (SAMHSA), the
                                                     Department of
                                                     Transportation
                                                     (DOT), and the U.S.
                                                     military.).
862.3270.............  Gas              LAD         Exemption is limited
                        Chromatography               to test systems
                        , Codeine.                   intended for
                                                     employment and
                                                     insurance testing
                                                     and does not
                                                     include test
                                                     systems intended
                                                     for Federal drug
                                                     testing programs
                                                     (e.g., programs run
                                                     by the Substance
                                                     Abuse and Mental
                                                     Health Services
                                                     Administration
                                                     (SAMHSA), the
                                                     Department of
                                                     Transportation
                                                     (DOT), and the U.S.
                                                     military.).
862.3580.............  Radioimmunoassa  DLB         Exemption is limited
                        y, LSD (125-I).              to test systems
                                                     intended for
                                                     employment and
                                                     insurance testing
                                                     and does not
                                                     include test
                                                     systems intended
                                                     for Federal drug
                                                     testing programs
                                                     (e.g., programs run
                                                     by the Substance
                                                     Abuse and Mental
                                                     Health Services
                                                     Administration
                                                     (SAMHSA), the
                                                     Department of
                                                     Transportation
                                                     (DOT), and the U.S.
                                                     military.).
862.3580.............  Free Radical     DOL         Exemption is limited
                        Assay, LSD.                  to test systems
                                                     intended for
                                                     employment and
                                                     insurance testing
                                                     and does not
                                                     include test
                                                     systems intended
                                                     for Federal drug
                                                     testing programs
                                                     (e.g., programs run
                                                     by the Substance
                                                     Abuse and Mental
                                                     Health Services
                                                     Administration
                                                     (SAMHSA), the
                                                     Department of
                                                     Transportation
                                                     (DOT), and the U.S.
                                                     military.).
862.3610.............  Gas              LAF         Exemption is limited
                        Chromatography               to test systems
                        ,                            intended for
                        Methamphetamin               employment and
                        e.                           insurance testing
                                                     and does not
                                                     include test
                                                     systems intended
                                                     for Federal drug
                                                     testing programs
                                                     (e.g., programs run
                                                     by the Substance
                                                     Abuse and Mental
                                                     Health Services
                                                     Administration
                                                     (SAMHSA), the
                                                     Department of
                                                     Transportation
                                                     (DOT), and the U.S.
                                                     military.).
862.3610.............  Thin Layer       DJC         Exemption is limited
                        Chromatography               to test systems
                        ,                            intended for
                        Methamphetamin               employment and
                        e.                           insurance testing
                                                     and does not
                                                     include test
                                                     systems intended
                                                     for Federal drug
                                                     testing programs
                                                     (e.g., programs run
                                                     by the Substance
                                                     Abuse and Mental
                                                     Health Services
                                                     Administration
                                                     (SAMHSA), the
                                                     Department of
                                                     Transportation
                                                     (DOT), and the U.S.
                                                     military.).

[[Page 13615]]

 
862.3610.............  High Pressure    LAG         Exemption is limited
                        Liquid                       to test systems
                        Chromatography               intended for
                        ,                            employment and
                        Methamphetamin               insurance testing
                        e.                           and does not
                                                     include test
                                                     systems intended
                                                     for Federal drug
                                                     testing programs
                                                     (e.g., programs run
                                                     by the Substance
                                                     Abuse and Mental
                                                     Health Services
                                                     Administration
                                                     (SAMHSA), the
                                                     Department of
                                                     Transportation
                                                     (DOT), and the U.S.
                                                     military.).
862.3610.............  Test,            NGG         Exemption is limited
                        Methamphetamin               to test systems
                        e, Over The                  intended for
                        Counter.                     employment and
                                                     insurance testing
                                                     and does not
                                                     include test
                                                     systems intended
                                                     for Federal drug
                                                     testing programs
                                                     (e.g., programs run
                                                     by the Substance
                                                     Abuse and Mental
                                                     Health Services
                                                     Administration
                                                     (SAMHSA), the
                                                     Department of
                                                     Transportation
                                                     (DOT), and the U.S.
                                                     military.).
862.3620.............  Enzyme           DJR         Exemption is limited
                        Immunoassay,                 to test systems
                        Methadone.                   intended for
                                                     employment and
                                                     insurance testing
                                                     and does not
                                                     include test
                                                     systems intended
                                                     for Federal drug
                                                     testing programs
                                                     (e.g., programs run
                                                     by the Substance
                                                     Abuse and Mental
                                                     Health Services
                                                     Administration
                                                     (SAMHSA), the
                                                     Department of
                                                     Transportation
                                                     (DOT), and the U.S.
                                                     military.).
862.3620.............  Hemagglutinatio  DIW         Exemption is limited
                        n Inhibition,                to test systems
                        Methadone.                   intended for
                                                     employment and
                                                     insurance testing
                                                     and does not
                                                     include test
                                                     systems intended
                                                     for Federal drug
                                                     testing programs
                                                     (e.g., programs run
                                                     by the Substance
                                                     Abuse and Mental
                                                     Health Services
                                                     Administration
                                                     (SAMHSA), the
                                                     Department of
                                                     Transportation
                                                     (DOT), and the U.S.
                                                     military.).
862.3620.............  Gas              DMB         Exemption is limited
                        Chromatography               to test systems
                        , Methadone.                 intended for
                                                     employment and
                                                     insurance testing
                                                     and does not
                                                     include test
                                                     systems intended
                                                     for Federal drug
                                                     testing programs
                                                     (e.g., programs run
                                                     by the Substance
                                                     Abuse and Mental
                                                     Health Services
                                                     Administration
                                                     (SAMHSA), the
                                                     Department of
                                                     Transportation
                                                     (DOT), and the U.S.
                                                     military.).
862.3620.............  Thin Layer       DKR         Exemption is limited
                        Chromatography               to test systems
                        , Methadone.                 intended for
                                                     employment and
                                                     insurance testing
                                                     and does not
                                                     include test
                                                     systems intended
                                                     for Federal drug
                                                     testing programs
                                                     (e.g., programs run
                                                     by the Substance
                                                     Abuse and Mental
                                                     Health Services
                                                     Administration
                                                     (SAMHSA), the
                                                     Department of
                                                     Transportation
                                                     (DOT), and the U.S.
                                                     military.).
862.3620.............  Liquid           DNT         Exemption is limited
                        Chromatography               to test systems
                        , Methadone.                 intended for
                                                     employment and
                                                     insurance testing
                                                     and does not
                                                     include test
                                                     systems intended
                                                     for Federal drug
                                                     testing programs
                                                     (e.g., programs run
                                                     by the Substance
                                                     Abuse and Mental
                                                     Health Services
                                                     Administration
                                                     (SAMHSA), the
                                                     Department of
                                                     Transportation
                                                     (DOT), and the U.S.
                                                     military.).
862.3620.............  Free Radical     DPP         Exemption is limited
                        Assay,                       to test systems
                        Methadone.                   intended for
                                                     employment and
                                                     insurance testing
                                                     and does not
                                                     include test
                                                     systems intended
                                                     for Federal drug
                                                     testing programs
                                                     (e.g., programs run
                                                     by the Substance
                                                     Abuse and Mental
                                                     Health Services
                                                     Administration
                                                     (SAMHSA), the
                                                     Department of
                                                     Transportation
                                                     (DOT), and the U.S.
                                                     military.).
862.3630.............  Radioimmunoassa  KXS         Exemption is limited
                        y,                           to test systems
                        Methaqualone.                intended for
                                                     employment and
                                                     insurance testing
                                                     and does not
                                                     include test
                                                     systems intended
                                                     for Federal drug
                                                     testing programs
                                                     (e.g., programs run
                                                     by the Substance
                                                     Abuse and Mental
                                                     Health Services
                                                     Administration
                                                     (SAMHSA), the
                                                     Department of
                                                     Transportation
                                                     (DOT), and the U.S.
                                                     military.).
862.3640.............  Thin Layer       DNK         Exemption is limited
                        Chromatography               to test systems
                        , Morphine.                  intended for
                                                     employment and
                                                     insurance testing
                                                     and does not
                                                     include test
                                                     systems intended
                                                     for Federal drug
                                                     testing programs
                                                     (e.g., programs run
                                                     by the Substance
                                                     Abuse and Mental
                                                     Health Services
                                                     Administration
                                                     (SAMHSA), the
                                                     Department of
                                                     Transportation
                                                     (DOT), and the U.S.
                                                     military.).
862.3640.............  Radioimmunoassa  DOE         Exemption is limited
                        y, Morphine                  to test systems
                        (123-I), Goat                intended for
                        Antibody                     employment and
                        Ammonium                     insurance testing
                        Sulfate Sep..                and does not
                                                     include test
                                                     systems intended
                                                     for Federal drug
                                                     testing programs
                                                     (e.g., programs run
                                                     by the Substance
                                                     Abuse and Mental
                                                     Health Services
                                                     Administration
                                                     (SAMHSA), the
                                                     Department of
                                                     Transportation
                                                     (DOT), and the U.S.
                                                     military.).
862.3640.............  Fluorometry,     DJJ         Exemption is limited
                        Morphine.                    to test systems
                                                     intended for
                                                     employment and
                                                     insurance testing
                                                     and does not
                                                     include test
                                                     systems intended
                                                     for Federal drug
                                                     testing programs
                                                     (e.g., programs run
                                                     by the Substance
                                                     Abuse and Mental
                                                     Health Services
                                                     Administration
                                                     (SAMHSA), the
                                                     Department of
                                                     Transportation
                                                     (DOT), and the U.S.
                                                     military.).
862.3640.............  Liquid           DPK         Exemption is limited
                        Chromatography               to test systems
                        , Morphine.                  intended for
                                                     employment and
                                                     insurance testing
                                                     and does not
                                                     include test
                                                     systems intended
                                                     for Federal drug
                                                     testing programs
                                                     (e.g., programs run
                                                     by the Substance
                                                     Abuse and Mental
                                                     Health Services
                                                     Administration
                                                     (SAMHSA), the
                                                     Department of
                                                     Transportation
                                                     (DOT), and the U.S.
                                                     military.).
862.3640.............  Gas              DMY         Exemption is limited
                        Chromatography               to test systems
                        , Morphine.                  intended for
                                                     employment and
                                                     insurance testing
                                                     and does not
                                                     include test
                                                     systems intended
                                                     for Federal drug
                                                     testing programs
                                                     (e.g., programs run
                                                     by the Substance
                                                     Abuse and Mental
                                                     Health Services
                                                     Administration
                                                     (SAMHSA), the
                                                     Department of
                                                     Transportation
                                                     (DOT), and the U.S.
                                                     military.).

[[Page 13616]]

 
862.3640.............  Hemagglutinatio  DLR         Exemption is limited
                        n Inhibition,                to test systems
                        Morphine.                    intended for
                                                     employment and
                                                     insurance testing
                                                     and does not
                                                     include test
                                                     systems intended
                                                     for Federal drug
                                                     testing programs
                                                     (e.g., programs run
                                                     by the Substance
                                                     Abuse and Mental
                                                     Health Services
                                                     Administration
                                                     (SAMHSA), the
                                                     Department of
                                                     Transportation
                                                     (DOT), and the U.S.
                                                     military.).
862.3640.............  Free Radical     DOK         Exemption is limited
                        Assay,                       to test systems
                        Morphine.                    intended for
                                                     employment and
                                                     insurance testing
                                                     and does not
                                                     include test
                                                     systems intended
                                                     for Federal drug
                                                     testing programs
                                                     (e.g., programs run
                                                     by the Substance
                                                     Abuse and Mental
                                                     Health Services
                                                     Administration
                                                     (SAMHSA), the
                                                     Department of
                                                     Transportation
                                                     (DOT), and the U.S.
                                                     military.).
862.3640.............  Radioimmunoassa  DIQ         Exemption is limited
                        y, Morphine (3-              to test systems
                        H), Goat                     intended for
                        Antibody                     employment and
                        Ammonium                     insurance testing
                        Sulfate Sep..                and does not
                                                     include test
                                                     systems intended
                                                     for Federal drug
                                                     testing programs
                                                     (e.g., programs run
                                                     by the Substance
                                                     Abuse and Mental
                                                     Health Services
                                                     Administration
                                                     (SAMHSA), the
                                                     Department of
                                                     Transportation
                                                     (DOT), and the U.S.
                                                     military.).
862.3640.............  Radioimmunoassa  DNA         Exemption is limited
                        y, Morphine-                 to test systems
                        Barbiturate                  intended for
                        (125-I), Goat                employment and
                        Antibody.                    insurance testing
                                                     and does not
                                                     include test
                                                     systems intended
                                                     for Federal drug
                                                     testing programs
                                                     (e.g., programs run
                                                     by the Substance
                                                     Abuse and Mental
                                                     Health Services
                                                     Administration
                                                     (SAMHSA), the
                                                     Department of
                                                     Transportation
                                                     (DOT), and the U.S.
                                                     military.).
862.3650.............  Enzyme           DJG         Exemption is limited
                        Immunoassay,                 to test systems
                        Opiates.                     intended for
                                                     employment and
                                                     insurance testing
                                                     and does not
                                                     include test
                                                     systems intended
                                                     for Federal drug
                                                     testing programs
                                                     (e.g., programs run
                                                     by the Substance
                                                     Abuse and Mental
                                                     Health Services
                                                     Administration
                                                     (SAMHSA), the
                                                     Department of
                                                     Transportation
                                                     (DOT), and the U.S.
                                                     military.).
862.3650.............  Gas              DJF         Exemption is limited
                        Chromatography               to test systems
                        , Opiates.                   intended for
                                                     employment and
                                                     insurance testing
                                                     and does not
                                                     include test
                                                     systems intended
                                                     for Federal drug
                                                     testing programs
                                                     (e.g., programs run
                                                     by the Substance
                                                     Abuse and Mental
                                                     Health Services
                                                     Administration
                                                     (SAMHSA), the
                                                     Department of
                                                     Transportation
                                                     (DOT), and the U.S.
                                                     military.).
862.3650.............  Hemagglutinatio  DLT         Exemption is limited
                        n, Opiates.                  to test systems
                                                     intended for
                                                     employment and
                                                     insurance testing
                                                     and does not
                                                     include test
                                                     systems intended
                                                     for Federal drug
                                                     testing programs
                                                     (e.g., programs run
                                                     by the Substance
                                                     Abuse and Mental
                                                     Health Services
                                                     Administration
                                                     (SAMHSA), the
                                                     Department of
                                                     Transportation
                                                     (DOT), and the U.S.
                                                     military.).
862.3650.............  Thin Layer       LAI         Exemption is limited
                        Chromatography               to test systems
                        , Opiates.                   intended for
                                                     employment and
                                                     insurance testing
                                                     and does not
                                                     include test
                                                     systems intended
                                                     for Federal drug
                                                     testing programs
                                                     (e.g., programs run
                                                     by the Substance
                                                     Abuse and Mental
                                                     Health Services
                                                     Administration
                                                     (SAMHSA), the
                                                     Department of
                                                     Transportation
                                                     (DOT), and the U.S.
                                                     military.).
862.3650.............  Free Radical     DKT         Exemption is limited
                        Assay, Opiates.              to test systems
                                                     intended for
                                                     employment and
                                                     insurance testing
                                                     and does not
                                                     include test
                                                     systems intended
                                                     for Federal drug
                                                     testing programs
                                                     (e.g., programs run
                                                     by the Substance
                                                     Abuse and Mental
                                                     Health Services
                                                     Administration
                                                     (SAMHSA), the
                                                     Department of
                                                     Transportation
                                                     (DOT), and the U.S.
                                                     military.).
862.3650.............  High Pressure    LAH         Exemption is limited
                        Liquid                       to test systems
                        Chromatography               intended for
                        , Opiates.                   employment and
                                                     insurance testing
                                                     and does not
                                                     include test
                                                     systems intended
                                                     for Federal drug
                                                     testing programs
                                                     (e.g., programs run
                                                     by the Substance
                                                     Abuse and Mental
                                                     Health Services
                                                     Administration
                                                     (SAMHSA), the
                                                     Department of
                                                     Transportation
                                                     (DOT), and the U.S.
                                                     military.).
862.3700.............  Enzyme           JXN         Exemption is limited
                        Immunoassay,                 to test systems
                        Propoxyphene.                intended for
                                                     employment and
                                                     insurance testing
                                                     and does not
                                                     include test
                                                     systems intended
                                                     for Federal drug
                                                     testing programs
                                                     (e.g., programs run
                                                     by the Substance
                                                     Abuse and Mental
                                                     Health Services
                                                     Administration
                                                     (SAMHSA), the
                                                     Department of
                                                     Transportation
                                                     (DOT), and the U.S.
                                                     military.).
862.3700.............  Thin Layer       DPN         Exemption is limited
                        Chromatography               to test systems
                        , Propoxyphene.              intended for
                                                     employment and
                                                     insurance testing
                                                     and does not
                                                     include test
                                                     systems intended
                                                     for Federal drug
                                                     testing programs
                                                     (e.g., programs run
                                                     by the Substance
                                                     Abuse and Mental
                                                     Health Services
                                                     Administration
                                                     (SAMHSA), the
                                                     Department of
                                                     Transportation
                                                     (DOT), and the U.S.
                                                     military.).
862.3700.............  Gas              LAJ         Exemption is limited
                        Chromatography               to test systems
                        , Propoxyphene.              intended for
                                                     employment and
                                                     insurance testing
                                                     and does not
                                                     include test
                                                     systems intended
                                                     for Federal drug
                                                     testing programs
                                                     (e.g., programs run
                                                     by the Substance
                                                     Abuse and Mental
                                                     Health Services
                                                     Administration
                                                     (SAMHSA), the
                                                     Department of
                                                     Transportation
                                                     (DOT), and the U.S.
                                                     military.).
862.3700.............  High Pressure    LAK         Exemption is limited
                        Liquid                       to test systems
                        Chromatography               intended for
                        , Propoxyphene.              employment and
                                                     insurance testing
                                                     and does not
                                                     include test
                                                     systems intended
                                                     for Federal drug
                                                     testing programs
                                                     (e.g., programs run
                                                     by the Substance
                                                     Abuse and Mental
                                                     Health Services
                                                     Administration
                                                     (SAMHSA), the
                                                     Department of
                                                     Transportation
                                                     (DOT), and the U.S.
                                                     military.).

[[Page 13617]]

 
862.3870.............  Enzyme           LDJ         Exemption is limited
                        Immunoassay,                 to test systems
                        Cannabinoids.                intended for
                                                     employment and
                                                     insurance testing
                                                     and does not
                                                     include test
                                                     systems intended
                                                     for Federal drug
                                                     testing programs
                                                     (e.g., programs run
                                                     by the Substance
                                                     Abuse and Mental
                                                     Health Services
                                                     Administration
                                                     (SAMHSA), the
                                                     Department of
                                                     Transportation
                                                     (DOT), and the U.S.
                                                     military.).
862.3870.............  Reagents, Test,  DKE         Exemption is limited
                        Tetrahydrocann               to test systems
                        abinol.                      intended for
                                                     employment and
                                                     insurance testing
                                                     and does not
                                                     include test
                                                     systems intended
                                                     for Federal drug
                                                     testing programs
                                                     (e.g., programs run
                                                     by the Substance
                                                     Abuse and Mental
                                                     Health Services
                                                     Administration
                                                     (SAMHSA), the
                                                     Department of
                                                     Transportation
                                                     (DOT), and the U.S.
                                                     military.).
862.3870.............  Radioimmunoassa  LAT         Exemption is limited
                        y,                           to test systems
                        Cannabinoid(S).              intended for
                                                     employment and
                                                     insurance testing
                                                     and does not
                                                     include test
                                                     systems intended
                                                     for Federal drug
                                                     testing programs
                                                     (e.g., programs run
                                                     by the Substance
                                                     Abuse and Mental
                                                     Health Services
                                                     Administration
                                                     (SAMHSA), the
                                                     Department of
                                                     Transportation
                                                     (DOT), and the U.S.
                                                     military.).
862.3910.............  High Pressure    LFI         Exemption is limited
                        Liquid                       to test systems
                        Chromatography               intended for
                        , Tricyclic                  employment and
                        Antidepressant               insurance testing
                        Drugs.                       and does not
                                                     include test
                                                     systems intended
                                                     for Federal drug
                                                     testing programs
                                                     (e.g., programs run
                                                     by the Substance
                                                     Abuse and Mental
                                                     Health Services
                                                     Administration
                                                     (SAMHSA), the
                                                     Department of
                                                     Transportation
                                                     (DOT), and the U.S.
                                                     military.).
862.3910.............  U.V.             LFH         Exemption is limited
                        Spectrometry,                to test systems
                        Tricyclic                    intended for
                        Antidepressant               employment and
                        Drugs.                       insurance testing
                                                     and does not
                                                     include test
                                                     systems intended
                                                     for Federal drug
                                                     testing programs
                                                     (e.g., programs run
                                                     by the Substance
                                                     Abuse and Mental
                                                     Health Services
                                                     Administration
                                                     (SAMHSA), the
                                                     Department of
                                                     Transportation
                                                     (DOT), and the U.S.
                                                     military.).
862.3910.............  Thin Layer       MLK         Exemption is limited
                        Chromatography               to test systems
                        , Tricyclic                  intended for
                        Antidepressant               employment and
                        Drugs.                       insurance testing
                                                     and does not
                                                     include test
                                                     systems intended
                                                     for Federal drug
                                                     testing programs
                                                     (e.g., programs run
                                                     by the Substance
                                                     Abuse and Mental
                                                     Health Services
                                                     Administration
                                                     (SAMHSA), the
                                                     Department of
                                                     Transportation
                                                     (DOT), and the U.S.
                                                     military.).
864.5400.............  Fibrometer.....  GIE         ....................
864.5400.............  Timer,           JBT         ....................
                        Coagulation.
864.5425.............  Control,         GGC         ....................
                        Plasma,
                        Abnormal.
864.5425.............  Plasma,          GGN         ....................
                        Coagulation
                        Control.
864.5425.............  Plasma,          GIZ         ....................
                        Control,
                        Normal.
864.6550.............  Control, Fecal   OSL         ....................
                        Occult Blood.
864.6650.............  Study, Platelet  JBZ         ....................
                        Adhesive.
864.7275.............  Test,            JBO         ....................
                        Euglobulin
                        Lysis.
864.7300.............  Fibrin Monomer   JBN         ....................
                        Paracoagulatio
                        n.
864.7340.............  Fibrinogen       GFX         ....................
                        Standard.
864.7340.............  Plasma,          GIL         ....................
                        Fibrinogen
                        Control.
864.7375.............  Glutathione,     GII         ....................
                        Red-Cell.
864.7375.............  Fluorescence,    JMH         ....................
                        Visual
                        Observation
                        (Qual., U.V.),
                        Glutathione
                        Reductase.
864.7375.............  Assay,           KQF         ....................
                        Glutathione
                        Reductase.
864.7415.............  Control,         JCM         ....................
                        Hemoglobin,
                        Abnormal.
864.7455.............  Stain, Fetal     GHQ         ....................
                        Hemoglobin.
864.7500.............  Acid Hematin...  GGF         ....................
864.7720.............  Test,            GGQ         ....................
                        Prothrombin
                        Consumption.
864.7735.............  Prothrombin-     JPF         ....................
                        Proconvertin
                        and
                        Thrombotest.
864.8150.............  Calibrator for   KRX         ....................
                        Cell Indices.
864.8165.............  Calibrator for   KRZ         ....................
                        Hemoglobin and
                        Hematocrit
                        Measurement.
864.8175.............  Calibrator for   KRY         ....................
                        Platelet
                        Counting.
864.8185.............  Calibrator for   KSA         ....................
                        Red-Cell and
                        White-Cell
                        Counting.
864.8625.............  Standards and    GFS         ....................
                        Controls,
                        Hemoglobin,
                        Normal and
                        Abnormal.
864.8625.............  Control, White-  GGL         ....................
                        Cell.
864.8625.............  Control,         GGM         ....................
                        Hemoglobin.
864.8625.............  Control,         GJP         ....................
                        Platelet.
864.8625.............  Control, Red-    GJR         ....................
                        Cell.
864.8625.............  Control,         GLK         ....................
                        Hematocrit.
864.8625.............  Mixture,         GLQ         ....................
                        Control, White-
                        Cell and Red-
                        Cell Indices.
864.8625.............  Control, Cell    JCN         ....................
                        Counter,
                        Normal and
                        Abnormal.
864.8625.............  Mixture,         JPK         ....................
                        Hematology
                        Quality
                        Control.

[[Page 13618]]

 
864.8625.............  Material,        NRF         ....................
                        Quality
                        Control, Semen
                        Analysis.
864.8625.............  Control          NRS         ....................
                        Material,
                        Blood
                        Circulating
                        Epithelial
                        Cancer Cell.
864.9400.............  Solution,        KSK         ....................
                        Stabilized
                        Enzyme.
866.3395.............  Norovirus        OUC         ....................
                        Serological
                        Reagents.
866.5210.............  Immunochemical,  CHN         ....................
                        Ceruloplasmin.
866.5210.............  Ceruloplasmin,   DCT         ....................
                        Rhodamine,
                        Antigen,
                        Antiserum,
                        Control.
866.5210.............  Ceruloplasmin,   DCY         ....................
                        FITC, Antigen,
                        Antiserum,
                        Control.
866.5210.............  Ceruloplasmin,   DDB         ....................
                        Antigen,
                        Antiserum,
                        Control.
866.5210.............  P-Phenyl-        JFQ         ....................
                        Enediamine/
                        EDTA
                        (Spectrophotom
                        etric),
                        Ceruloplasmin.
866.5210.............  Indirect Copper  JFR         ....................
                        Assay,
                        Ceruloplasmin.
866.5470.............  Hemoglobin,      DAM         ....................
                        Chain
                        Specific,
                        Antigen,
                        Antiserum,
                        Control.
866.5620.............  Alpha-2-         DDT         ....................
                        Macroglobulin,
                        Rhodamine,
                        Antigen,
                        Antiserum,
                        Control.
866.5620.............  Alpha-2-         DDY         ....................
                        Macroglobulin,
                        FITC, Antigen,
                        Antiserum,
                        Control.
866.5620.............  Alpha-2-         DEB         ....................
                        Macroglobulin,
                        Antigen,
                        Antiserum,
                        Control.
866.5630.............  System, Test,    JZG         ....................
                        Beta-2-
                        Microglobulin
                        Immunological.
866.5750.............  System, Test,    DHB         Exemption is limited
                        Radioallergoso               to devices
                        rbent (RAST)                 classified under 21
                        Immunological.               CFR 866.5750 that
                                                     are intended to
                                                     detect any of the
                                                     allergens included
                                                     in table 2 of this
                                                     document.
866.5910.............  Quality Control  NZB         ....................
                        Material,
                        Genetics, DNA.
868.1040.............  Algesimeter,     BSI         ....................
                        Powered.
868.1400.............  Legging,         LLK         ....................
                        Compression,
                        Non-Inflatable.
868.2385.............  Analyzer,        MRQ         Exemption is limited
                        Nitrogen                     to standalone
                        Dioxide.                     nitrogen dioxide
                                                     analyzers and not
                                                     those that are
                                                     components of
                                                     nitric oxide
                                                     delivery systems
                                                     intended to monitor
                                                     nitrogen dioxide
                                                     levels during
                                                     inhaled nitric
                                                     oxide therapy.
868.2500.............  Monitor,         KLK         ....................
                        Oxygen,
                        Cutaneous, For
                        Infant Not
                        Under Gas
                        Anesthesia.
868.2500.............  Monitor,         LPP         ....................
                        Oxygen,
                        Cutaneous, For
                        Uses Other
                        Than For
                        Infant Not
                        Under Gas
                        Anesthesia.
868.2550.............  Pneumotachomete  JAX         ....................
                        r.
868.5180.............  Bed, Rocking,    CCO         ....................
                        Breathing
                        Assist.
868.6250.............  Compressor,      BTI         ....................
                        Air, Portable.
870.1330.............  Wire, Guide,     DQX         Exemption is limited
                        Catheter.                    to accessory torque
                                                     devices that are
                                                     manually operated,
                                                     non-patient
                                                     contacting, and
                                                     intended to
                                                     manipulate non-
                                                     cerebral vascular
                                                     guide wires.
870.1390.............  Trocar.........  DRC         ....................
870.1650.............  Syringe,         MAV         Exemption is limited
                        Balloon                      to non-patient
                        Inflation.                   contacting balloon
                                                     inflation syringes
                                                     intended only to
                                                     inflate/deflate
                                                     balloon catheters
                                                     and monitor
                                                     pressure within the
                                                     balloon.
870.1875.............  Lung Sound       OCR         ....................
                        Monitor.
870.2675.............  Oscillometer...  DRZ         ....................
870.2770.............  Analyzer, Body   MNW         Exemption is limited
                        Composition.                 to body composition
                                                     analyzers which are
                                                     not intended to
                                                     diagnose or treat
                                                     any medical
                                                     condition.
870.4280.............  Filter,          KRJ         ....................
                        Prebypass,
                        Cardiopulmonar
                        y Bypass.
870.4290.............  Adaptor,         DTL         ....................
                        Stopcock,
                        Manifold,
                        Fitting,
                        Cardiopulmonar
                        y Bypass.
870.4340.............  Monitor and/or   DTW         ....................
                        Control, Level
                        Sensing,
                        Cardiopulmonar
                        y Bypass.
870.4400.............  Reservoir,       DTN         Exemption is limited
                        Blood,                       to cardiopulmonary
                        Cardiopulmonar               bypass blood
                        y Bypass.                    reservoirs that do
                                                     not contain
                                                     defoamers or blood
                                                     filters.
870.4420.............  Sucker,          DTS         ....................
                        Cardiotomy
                        Return,
                        Cardiopulmonar
                        y Bypass.
870.4430.............  Suction          DWD         ....................
                        Control,
                        Intracardiac,
                        Cardiopulmonar
                        y Bypass.
872.1720.............  Tester, Pulp...  EAT         ....................

[[Page 13619]]

 
872.3260.............  External         PME         ....................
                        Cleaning
                        Solution.
872.3300.............  Coating,         EBE         ....................
                        Denture
                        Hydrophilic,
                        Resin.
872.3540.............  Pad, Denture,    EHR         ....................
                        Over The
                        Counter.
872.3540.............  Cushion,         EHS         ....................
                        Denture, Over
                        The Counter.
872.3560.............  Reliner,         EBP         ....................
                        Denture, Over
                        The Counter.
872.3590.............  Denture,         ELM         ....................
                        Plastic, Tooth.
872.3600.............  Denture          EKO         ....................
                        Preformed
                        (Partially
                        Prefabricated
                        Denture).
872.3890.............  Splint,          ELS         ....................
                        Endodontic
                        Stabilizing.
872.5550.............  Ring, Teething,  KKO         ....................
                        Fluid-Filled.
872.6770.............  Syringe,         EJI         ....................
                        Cartridge.
874.1090.............  Tester,          ETY         Exemption is limited
                        Auditory                     to auditory
                        Impedance.                   impedance testers
                                                     that are in
                                                     compliance with FDA-
                                                     recognized
                                                     consensus standard
                                                     ANSI S3.39.
874.1090.............  Tympanometer...  NAS         Exemption is limited
                                                     to tympanometers
                                                     that are in
                                                     compliance with FDA-
                                                     recognized
                                                     consensus standard
                                                     ANSI S3.39.
874.1120.............  Generator,       ETS         ....................
                        Electronic
                        Noise (for
                        Audiometric
                        Testing).
874.1325.............  Electroglottogr  KLX         ....................
                        aph.
874.3310.............  Calibrator,      ETW         ....................
                        Hearing Aid/
                        Earphone and
                        Analysis
                        Systems.
874.3320.............  Hearing Aid,     EPF         ....................
                        Group and
                        Auditory
                        Trainer.
874.3320.............  Device,          LZI         ....................
                        Assistive
                        Listening.
874.3330.............  Hearing Aid,     KHL         ....................
                        Master.
874.3430.............  Mold, Middle-    ETC         ....................
                        Ear.
874.3730.............  Device, Voice    MCK         ....................
                        Amplification.
876.1500.............  Endoscopic       FCC         Exemption is limited
                        Magnetic                     to endoscopic
                        Retriever.                   magnetic retrievers
                                                     intended for single
                                                     use.
876.1500.............  Light Source,    FCQ         ....................
                        Incandescent,
                        Diagnostic.
876.1500.............  Light Source,    FCR         ....................
                        Photographic,
                        Fiberoptic.
876.1500.............  Light Source,    FCW         ....................
                        Fiberoptic,
                        Routine.
876.1500.............  Carrier,         FGS         ....................
                        Sponge,
                        Endoscopic.
876.1500.............  Light Source,    GCT         ....................
                        Endoscope,
                        Xenon Arc.
876.1500.............  Transformer,     GCW         ....................
                        Endoscope.
876.1500.............  Scissors For     KGD         Exemption is limited
                        Cystoscope.                  to sterile scissors
                                                     for cystoscope
                                                     intended for single
                                                     use.
876.1500.............  LED Light        NTN         ....................
                        Source.
876.1500.............  Endoscopic       OCY         ....................
                        Guide Wire,
                        Gastroenterolo
                        gy-Urology.
876.1500.............  Endoscopic       OCZ         Exemption is limited
                        Grasping/                    to disposable, non-
                        Cutting                      powered endoscopic
                        Instrument,                  grasping/cutting
                        Non-Powered.                 instruments
                                                     intended for single
                                                     use.
876.4020.............  Light,           FCS         ....................
                        Catheter,
                        Fiberoptic,
                        Glass,
                        Ureteral.
876.4270.............  Rod, Colostomy.  EZP         ....................
876.4400.............  Ligator,         FHN         ....................
                        Hemorrhoidal.
876.4400.............  Ligator,         MND         ....................
                        Esophageal.
876.4500.............  Lithotriptor,    LQC         ....................
                        Biliary
                        Mechanical.
876.4770.............  Urethrotome....  EZO         ....................
876.5010.............  Bag, Bile        EXF         ....................
                        Collecting.
876.5010.............  Catheter,        GCA         Exemption is limited
                        Biliary,                     to surgical biliary
                        Surgical.                    catheters that do
                                                     not include a
                                                     balloon component.
876.5025.............  Vibrator for     PIA         ....................
                        Climax Control
                        of Premature
                        Ejaculation.
876.5365.............  Dilator,         EZM         ....................
                        Esophageal
                        (Metal Olive)
                        Gastro-Urology.
876.5365.............  Bougie,          FAT         ....................
                        Esophageal,
                        and
                        Gastrointestin
                        al, Gastro-
                        Urology.
876.5365.............  Dilator,         KNQ         ....................
                        Esophageal.
876.5520.............  Dilator,         KOE         ....................
                        Urethral.
876.5630.............  Catheter,        FJS         Exemption is limited
                        Peritoneal,                  to non-patient
                        Long-Term                    contacting catheter
                        Indwelling.                  finger grips
                                                     intended for single
                                                     use.
876.5630.............  Catheter,        FKO         Exemption is limited
                        Peritoneal                   to non-patient
                        Dialysis,                    contacting catheter
                        Single Use.                  finger grips
                                                     intended for single
                                                     use.
876.5630.............  System,          FKX         Exemption is limited
                        Peritoneal,                  to continuous
                        Automatic                    ambulatory
                        Delivery.                    peritoneal dialysis
                                                     (CAPD) belts and
                                                     catheter stands
                                                     that do not include
                                                     weigh scales.
876.5665.............  Disinfectant,    NIH         ....................
                        Subsystem,
                        Water
                        Purification.
876.5820.............  Set, Dialyzer    FKI         ....................
                        Holder.
876.5895.............  Irrigator,       EXD         ....................
                        Ostomy.

[[Page 13620]]

 
876.5980.............  Catheter,        FGD         ....................
                        Retention,
                        Barium Enema
                        With Bag.
876.5980.............  Gastrostomy      PLI         ....................
                        Tube Holder.
878.4370.............  Drape,           ERY         ....................
                        Surgical, ENT.
878.4370.............  Drape, Pure      EYX         ....................
                        Latex Sheet,
                        With Self-
                        Retaining
                        Finger Cot.
878.4370.............  Drape,           EYY         ....................
                        Urological,
                        Disposable.
878.4370.............  Pad, Kelly.....  FNW         ....................
878.4370.............  Drape, Patient,  HMT         ....................
                        Ophthalmic.
878.4370.............  Drape,           HMW         ....................
                        Microscope,
                        Ophthalmic.
878.4370.............  Ring (Wound      KGW         ....................
                        Protector),
                        Drape
                        Retention,
                        Internal.
878.4370.............  Drape, Surgical  KKX         Exemption is limited
                                                     to surgical drapes
                                                     that do not include
                                                     an antimicrobial
                                                     agent.
878.4495.............  Suture,          GAQ         Exemption is limited
                        Nonabsorbable,               to steel
                        Steel,                       monofilament
                        Monofilament                 sutures that are
                        And                          uncoated and do not
                        Multifilament,               incorporate barbs.
                        Sterile.
878.4580.............  Lamp, Operating- FQP         ....................
                        Room.
878.4580.............  Light,           FSQ         ....................
                        Surgical,
                        Instrument.
878.4580.............  Light,           FSS         ....................
                        Surgical,
                        Floor Standing.
878.4580.............  Light,           FSW         ....................
                        Surgical,
                        Endoscopic.
878.4580.............  Light,           FSX         ....................
                        Surgical,
                        Connector.
878.4580.............  Light,           FSY         ....................
                        Surgical,
                        Ceiling
                        Mounted.
878.4580.............  Light,           FSZ         ....................
                        Surgical,
                        Carrier.
878.4580.............  Light,           FTA         ....................
                        Surgical,
                        Accessories.
878.4580.............  Lamp, Surgical.  FTD         ....................
878.4580.............  Illuminator,     FTG         ....................
                        Remote.
878.4580.............  Lamp, Surgical,  GBC         ....................
                        Incandescent.
878.5070.............  Apparatus, Air   FZG         ....................
                        Handling,
                        Bench.
878.5070.............  Apparatus, Air   FZH         ....................
                        Handling, Room.
878.5070.............  Apparatus, Air   FZI         ....................
                        Handling,
                        Enclosure.
880.5580.............  Locator,         BWJ         ....................
                        Acupuncture
                        Point.
880.5580.............  Needle,          MQX         ....................
                        Acupuncture,
                        Single Use.
880.5780.............  Stocking,        DWL         ....................
                        Medical
                        Support (to
                        Prevent
                        Pooling of
                        Blood in Legs).
882.1020.............  Analyzer,        GZM         ....................
                        Rigidity.
882.1470.............  Computerized     PKQ         Exemption is limited
                        Cognitive                    to computerized
                        Assessment Aid.              cognitive
                                                     assessment aids
                                                     that are not
                                                     intended for
                                                     diagnostic
                                                     assessment of
                                                     specific diseases
                                                     or conditions and
                                                     rely on inputs from
                                                     visual cues,
                                                     auditory cues, and/
                                                     or functional use
                                                     of the hand.
882.1540.............  Device,          GZO         ....................
                        Galvanic Skin
                        Response
                        Measurement.
882.1560.............  Device, Skin     HCJ         ....................
                        Potential
                        Measurement.
882.1855.............  Encephalogram    GYE         ....................
                        Telemetry
                        System.
882.5895.............  Vibratory        OVP         ....................
                        Counter-
                        Stimulation.
884.1630.............  Colposcope (and  HEX         Exemption is limited
                        Colpomicroscop               to standard
                        e).                          colposcopes (and
                                                     colpomicroscopes)
                                                     that use only a
                                                     white light source,
                                                     do not use filters
                                                     other than a green
                                                     filter, do not
                                                     include image
                                                     analysis software,
                                                     and are not
                                                     smartphone-based.
884.2990.............  Sheet,           NHM         ....................
                        Recording,
                        Breast
                        Examination.
884.3200.............  Drain, Cervical  HFL         ....................
884.4400.............  Forceps,         HDA         ....................
                        Obstetrical.
884.4530.............  Tenaculum,       HDC         Exemption is limited
                        Uterine.                     to sterile urterine
                                                     tenaculum devices
                                                     that do not use
                                                     suction and are
                                                     intended for single
                                                     use.
884.4530.............  Clamp,           HFW         ....................
                        Umbilical.
884.4530.............  Speculum,        HIB         ....................
                        Vaginal,
                        Nonmetal.
884.4530.............  Speculum,        HIC         ....................
                        Vaginal,
                        Nonmetal,
                        Fiberoptic.
884.4530.............  Clamp and        NBZ         ....................
                        Cutter,
                        Umbilical.
884.4900.............  Table,           HDD         ....................
                        Obstetrical,
                        AC-Powered
                        (and
                        Accessories).
884.4900.............  Table,           HHP         ....................
                        Obstetrical,
                        Manual (and
                        Accessories).
884.4900.............  Table,           KNC         ....................
                        Obstetric (and
                        Accessories).
884.5200.............  Hemorrhoid       OOA         ....................
                        Prevention
                        Pressure Wedge.
884.5390.............  Heater,          HGZ         ....................
                        Perineal,
                        Direct Contact.
884.5390.............  Heater,          HHA         ....................
                        Perineal,
                        Radiant, Non-
                        Contact.
884.5390.............  Heater,          KND         ....................
                        Perineal.
884.5400.............  Cup, Menstrual.  HHE         ....................

[[Page 13621]]

 
884.5425.............  Pad, Menstrual,  HHL         ....................
                        Scented.
884.6120.............  Accessory,       MQG         Exemption is limited
                        Assisted                     to single embryo
                        Reproduction.                incubators with
                                                     temperature, gas,
                                                     and humidity
                                                     control only;
                                                     syringe pumps;
                                                     collection tube
                                                     warmers; dish/plate/
                                                     microscope stage
                                                     warmers; and
                                                     controlled-rate
                                                     cryopreservation
                                                     freezers.
884.6130.............  Microtools,      MQH         Exemption is limited
                        Assisted                     to assisted
                        Reproduction                 reproduction
                        (Pipettes).                  microtools
                                                     (pipettes)
                                                     manufactured from
                                                     glass.
884.6150.............  Micromanipulato  MQJ         ....................
                        rs and
                        Microinjectors
                        , Assisted
                        Reproduction.
884.6160.............  Labware,         MQK         Exemption is limited
                        Assisted                     to dishes and
                        Reproduction.                plates that are
                                                     intended for
                                                     general assisted
                                                     reproduction
                                                     technology
                                                     procedures.
886.1120.............  Photorefractor.  MMF         ....................
886.1120.............  Camera,          PJZ         ....................
                        Ophthalmic,
                        General-Use.
886.1250.............  Euthyscope, AC-  HMK         ....................
                        Powered.
886.1570.............  Ophthalmoscope,  HLI         ....................
                        AC-Powered.
886.1570.............  Ophthalmoscope,  HLJ         ....................
                        Battery-
                        Powered.
886.1570.............  Ophthalmoscopes  MSG         ....................
                        , Replacement
                        Batteries,
                        Hand-Held.
886.1780.............  Retinoscope, AC- HKL         ....................
                        Powered.
886.1850.............  Biomicroscope,   HJO         Exemption is limited
                        Slit-Lamp, AC-               to slit-lamp, AC-
                        Powered.                     powered
                                                     biomicroscopes
                                                     intended only for
                                                     the visual
                                                     examination of the
                                                     anterior segment of
                                                     the eye, are
                                                     classified as Group
                                                     1 per FDA-
                                                     recognized
                                                     consensus standard
                                                     ANSI Z80.36, do not
                                                     provide any
                                                     quantitative
                                                     output, and are not
                                                     intended for
                                                     screening or
                                                     automated
                                                     diagnostic
                                                     indications.
886.1945.............  Transilluminato  HJM         ....................
                        r, AC-Powered.
886.3320.............  Ocular Peg.....  MQU         Exemption is limited
                                                     to ocular pegs
                                                     supplied sterile.
886.4150.............  Tubing,          MSR         ....................
                        Replacement,
                        Phacofragmenta
                        tion Unit.
886.4250.............  Unit,            HRO         ....................
                        Electrolysis,
                        AC-Powered,
                        Ophthalmic.
886.4335.............  Headlight,       FCT         ....................
                        Fiberoptic
                        Focusing.
886.4335.............  Light,           FSR         ....................
                        Headband,
                        Surgical.
886.4335.............  Headlamp,        HPQ         ....................
                        Operating, AC-
                        Powered.
886.4400.............  Locator, Metal,  HPM         ....................
                        Electronic.
886.4440.............  Magnet, AC-      HPO         ....................
                        Powered.
886.4790.............  Sponge,          HOZ         ....................
                        Ophthalmic.
886.4790.............  Eye Tray.......  OJK         ....................
888.1240.............  Dynamometer, AC- LBB         ....................
                        Powered.
888.4580.............  Instrument,      JDX         ....................
                        Surgical,
                        Sonic and
                        Accessory/
                        Attachment.
888.4580.............  System, Cement   LZV         ....................
                        Removal
                        Extraction.
890.1450.............  Hammer, Reflex,  IKO         ....................
                        Powered.
890.5100.............  Bath, Hydro-     ILJ         ....................
                        Massage.
890.5100.............  Bath, Sitz,      ILM         ....................
                        Powered.
890.5110.............  Bath, Paraffin.  IMC         ....................
890.5250.............  Cabinet, Moist   IMB         ....................
                        Steam.
890.5360.............  Exerciser,       ISD         ....................
                        Measuring.
890.5500.............  Lamp, Infrared,  ILY         ....................
                        Therapeutic
                        Heating.
890.5575.............  Device,          IRN         ....................
                        Warning,
                        Overload,
                        External Limb,
                        Powered.
892.1000.............  MRI Disposable   OIM         ....................
                        Kit.
892.1560.............  Biopsy Needle    OIJ         ....................
                        Guide Kit.
892.1610.............  Aperature,       IZS         ....................
                        Radiographic.
892.1610.............  Cone,            IZT         ....................
                        Radiographic.
892.1610.............  Collimator,      IZW         ....................
                        Automatic,
                        Radiographic.
892.1610.............  Collimator,      IZX         ....................
                        Manual,
                        Radiographic.
892.1610.............  Device, Beam     KPW         ....................
                        Limiting, X-
                        Ray,
                        Diagnostic.
892.1650.............  Arthrogram Tray  OII         ....................
892.1650.............  Radiology        OIK         ....................
                        Dental Tray.
892.1670.............  Device, Spot-    IXL         ....................
                        Film.
892.1680.............  Radiographic     OIO         ....................
                        Contrast Tray.
892.1680.............  Radiology        OIP         ....................
                        Diagnostic Kit.
892.1730.............  Discography Kit  OIL         ....................
892.1820.............  Chair,           HBK         ....................
                        Pneumocephalog
                        raphic.
892.1850.............  Cassette,        IXA         ....................
                        Radiographic
                        Film.
892.1860.............  Changer,         KPX         ....................
                        Radiographic
                        Film/Cassette.
892.1870.............  Programmer,      IZP         ....................
                        Changer, Film/
                        Cassette,
                        Radiographic.

[[Page 13622]]

 
892.1900.............  Controller,      EGT         ....................
                        Temperature,
                        Radiographic.
892.1900.............  Dryer, Film,     EGW         ....................
                        Radiographic.
892.1900.............  Processor,       EGY         ....................
                        Radiographic-
                        Film,
                        Automatic,
                        Dental.
892.1900.............  Processor,       IXW         ....................
                        Radiographic-
                        Film,
                        Automatic.
892.1900.............  Processor, Cine  IXX         ....................
                        Film.
892.2030.............  Digitizer,       LMA         ....................
                        Image,
                        Radiological.
892.2030.............  Digitizer,       NFH         ....................
                        Images,
                        Ophthalmic.
892.2040.............  Camera, Multi    LMC         ....................
                        Format,
                        Radiological.
892.2040.............  Device,          NFI         ....................
                        Hardcopy,
                        Images,
                        Ophthalmic.
892.5730.............  Prostate         OIN         ....................
                        Seeding Kit.
------------------------------------------------------------------------

    In table 1, FDA included devices classified under Sec.  866.5750 
(Radioallergosorbent (RAST) immunological test system, product code 
``DHB''). FDA does not believe that all devices with the product code 
DHB meet the exemption criteria from premarket notification 
requirements. However, FDA is identifying a substantial amount of these 
devices for exemption in table 2.

 Table 2--Class II Devices (Sec.   866.5750--Radioallergosorbent (RAST)
                       Immunological Test Systems)
------------------------------------------------------------------------
                                                     Source (taxonomical
       Allergen code            Allergen product            name)
------------------------------------------------------------------------
                              Grass Pollens
------------------------------------------------------------------------
g1.........................  Sweet vernal grass...  Anthoxanthum
                                                     odoratum.
g3.........................  Cocksfoot grass,       Dactylis glomerata.
                              Orchard grass.
g4.........................  Meadow fescue........  Festuca elatior.
g5.........................  Rye-grass (perennial   Lolium perenne.
                              rye grass).
g7.........................  Common reed (common    Phragmites communis.
                              reed grass).
g8.........................  Meadow grass,          Poa pratensis.
                              Kentucky blue (June
                              grass).
g9.........................  Redtop, Bentgrass....  Agrostis
                                                     stolonifera,
                                                     Agrostis gigantea
                                                     (Agrostis alba).
g11........................  Brome grass..........  Bromus inermis.
g12........................  Cultivated rye         Secale cereale.
                              (cultivated rye
                              grass).
g13........................  Velvet grass.........  Holcus lanatus.
g14........................  Cultivated oat         Avena sativa.
                              (cultivated oat
                              grass).
g15........................  Cultivated wheat       Triticum aestivum
                              (cultivated wheat      (Triticum spp.).
                              grass).
g16........................  Meadow foxtail         Alopecurus
                              (meadow foxtail        pratensis.
                              grass).
g17........................  Bahia grass..........  Paspalum notatum.
g24........................  Wheat grass, Western.  Agropyron smithii
                                                     (Elymus smithii).
g30........................  Bluegrass, annual....  Poa annua.
g70........................  Wild rye grass.......  Elymus triticoides,
                                                     Elymus condensatus.
g71........................  Canary grass.........  Phalaris
                                                     arundinacea.
g201.......................  Barley, cultivated...  Hordeum vulgare.
g202.......................  Maize, corn            Zea mays.
                              (cultivated corn).
g203.......................  Salt grass...........  Distichlis spicata.
g204.......................  False oat-grass......  Arrhenatherum
                                                     elatius.
g216.......................  Cyn d 1..............  Cynodon dactylon.
g701.......................  Phl p 1.0102, Phl p    Phleum pratense.
                              5.0101.
g702.......................  Phl p 7.0101.........  Phleum pratense.
g703.......................  Phl p 12.0101........  Phleum pratense.
------------------------------------------------------------------------
                              Weed Pollens
------------------------------------------------------------------------
w2.........................  Western ragweed......  Ambrosia
                                                     psilostachya.
w4.........................  False ragweed........  Ambrosia
                                                     acanthicarpa
                                                     (Franseria
                                                     acanthicarpa).
w5.........................  Wormwood.............  Artemisia
                                                     absinthium,
                                                     Artemisia annua.
w6.........................  Mugwort..............  Artemisia vulgaris.
w7.........................  Marguerite, ox-eye     Chrysanthemum
                              daisy.                 leucanthemum.
w8.........................  Dandelion............  Taraxacum vulgare,
                                                     Taraxacum
                                                     officinale.
w9.........................  Plantain (English),    Plantago lanceolata.
                              Ribwort.
w10........................  Goosefoot, lamb's      Chenopodium album.
                              quarters.
w11........................  Saltwort (prickly),    Salsola kali
                              Russian thistle.       (Salsola pestifer).
w12........................  Goldenrod............  Solidago virgaurea
                                                     (Solidago spp.).
w13........................  Cocklebur, common....  Xanthium commune.
w14........................  Common pigweed (rough  Amaranthus
                              pigweed).              retroflexus.
w15........................  Scale, Lenscale......  Atriplex
                                                     lentiformis.

[[Page 13623]]

 
w16........................  Rough marsh elder....  Iva ciliate, Iva
                                                     annua.
w17........................  Firebush (Kochia)....  Kochia scoparia.
w18........................  Sheep sorrel.........  Rumex acetosella.
w19........................  Wall pellitory.......  Parietaria
                                                     officinalis.
w20........................  Nettle (Common         Urtica dioica.
                              stinging nettle).
w21........................  Wall pellitory.......  Parietaria judaica.
w22........................  Japanese hop           Humulus japonicas
                              (careless weed).       (Humulus scandens).
w23........................  Yellow dock, Yellow    Rumex crispus.
                              dockweed.
w24........................  Spiny pigweed........  Amaranthus spinosus.
w27........................  Carnation............  Dianthus spp.
w28........................  Rose.................  Rosa rugosa.
w33........................  Clover...............  Trifolium pratense.
w35........................  Mexican tea..........  Chenopodium
                                                     ambrosioides.
w36........................  Rabbit bush..........  Ambrosia deltoidea
                                                     (Franseria
                                                     deltoides).
w37........................  Salt bush, annual....  Atriplex wrightii.
w39........................  Water hemp, Western..  Amaranthus rudis
                                                     (Acnida
                                                     tamariscina).
w41........................  Burrobrush...........  Hymenoclea salsola.
w42........................  Poverty weed.........
w43........................  Common sagebrush.....  Artemisia
                                                     tridentata.
w45........................  Alfalfa..............  Medicago sativa.
w46........................  Dog fennel...........  Eupatorium
                                                     capillifolium.
w53........................  Geranium.............  Geranium spp.
w67........................  Groundsel bush.......  Baccharis
                                                     halimifolia.
w69........................  Iodine bush..........  Allenrolfea
                                                     occidentalis.
w70........................  Ragweed, slender.....  Ambrosia
                                                     confertiflora.
w75........................  Wing scale             Atriplex canescens.
                              (wingscale).
w82........................  Careless weed........  Amaranthus palmeri,
                                                     Amaranthus
                                                     hybridus.
w90........................  Japanese hop.........  Humulus japonicas
                                                     (Humulus scandens).
w203.......................  Rape (rape pollen)...  Brassica napus.
w204.......................  Sunflower............  Helianthus annuus.
w206.......................  Camomile.............  Matricaria
                                                     chamomilla.
w207.......................  Lupin................  Lupinus spp.
w210.......................  Sugar-beet...........  Beta vulgaris.
w211.......................  Par j 2.0101.........  Parietaria judaica.
w231.......................  Art v 1..............  Artemisia vulgaris
                                                     (Mugwort).
w232.......................  Sal k 1..............  Salsola kali.
w233.......................  Art v 3..............  Artemisa vulgaris
                                                     (LTP, Mugwort).
w234.......................  Pla l 1..............  Plantago lanceolata.
w235.......................  Che a 1.0101.........  Chenopodium album.
w236.......................  Mer a 1.0101.........  Mercurialis annua.
a753.......................  Art v 1..............  Artemisia vulgaris
                                                     (Mugwort weed).
------------------------------------------------------------------------
                              Tree Pollens
------------------------------------------------------------------------
t1.........................  Box-elder (Maple)....  Acer negundo, Acer
                                                     saccharum.
t2.........................  Gray alder, speckled   Alnus incana.
                              alder (alder).
t4.........................  Hazel, hazelnut......  Corylus avellana,
                                                     Corylus americana.
t5.........................  American beech         Fagus grandifolia
                              (beech).               (Fagus americana).
t6.........................  Mountain juniper,      Juniperus ashei
                              Mountain cedar.        (Juniperus
                                                     sabinoides).
t8.........................  Elm..................  Ulmus americana.
t9.........................  Olive................  Olea europaea.
t10........................  Walnut...............  Juglans californica,
                                                     Juglans nigra.
t11........................  Maple leaf sycamore,   Platanus acerifolia.
                              London plane, Plane
                              tree.
t61........................  Sycamore.............  Platanus
                                                     occidentalis.
t12........................  Willow...............  Salix caprea, Salix
                                                     nigra.
t14........................  Cottonwood (Eastern    Populus deltoides.
                              Cottonwood/Black
                              Cottonwood).
t15........................  White ash............  Fraxinus americana.
t16........................  White pine...........  Pinus strobus.
t18........................  Eucalyptus, gum-tree.  Eucalyptus globulus
                                                     (Eucalyptus spp.).
t19/t26....................  Acacia...............  Acacia longifolia
                                                     (Acacia spp.).
t20........................  Mesquite.............  Prosopis glandulosa/
                                                    Prosopis juliflora.
t21........................  Melaleuca, cajeput     Melaleuca
                              tree.                  quinquenervia
                                                     (Melaleuca
                                                     leucadendron).
t22........................  Pecan, hickory.......  Carya illinoinensis
                                                     (Carya pecan).
t23........................  Italian/Mediterranean/ Cupressus
                              funeral cypress.       sempervirens.
t24........................  Japanese cypress.....  Chamaecyparis obtusa
                                                     (Chamaecyparis
                                                     spp.).
t25........................  Ash..................  Fraxinus excelsior.
t27........................  Maple, red...........  Acer rubrum.
t29........................  Acacia...............  Acacia spp.
t30........................  Birch, white.........  Betula populifolia.

[[Page 13624]]

 
t32........................  Willow, black........  Salix nigra.
t33........................  Ash, Arizona.........  Fraxinus velutina.
t35........................  Cedar, salt..........  Tamarix gallica.
t37........................  Bald cypress (white    Taxodium distichum.
                              bald cypress).
t38........................  Elm, Chinese/Siberian  Ulmus pumila.
t40........................  Hazelnut tree........  Corylus americana.
t41........................  White hickory........  Carya alba (Carya
                                                     tomentosa).
t42........................  Oak, red.............  Quercus rubra.
t43........................  Loblolly pine........  Pinus taeda.
t44........................  Hackberry............  Celtis occidentalis.
t45........................  Cedar elm............  Ulmus crassifolia.
t47........................  Juniper, one seed....  Juniperus
                                                     monosperma.
t48........................  Pine, lodgepole......  Pinus contorta.
t49........................  Pine, ponderosa......  Pinus ponderosa.
t50........................  Beech, European......  Fagus sylvatica.
t51........................  Tree of Heaven.......  Ailanthus altissima.
t52........................  Western white pine...  Pinus monticola.
t54........................  Russian olive........  Elaeagnus
                                                     angustifolia.
t55........................  Scotch broom.........  Cytisus scoparius.
t56........................  Bayberry.............  Myrica cerifera.
t57........................  Red cedar............  Juniperus
                                                     virginiana.
t60........................  Western juniper......  Juniperus
                                                     occidentalis.
t61........................  Sycamore.............  Platanus
                                                     occidentalis.
t70........................  Mulberry (white        Morus alba.
                              mulberry).
t71........................  Red mulberry.........  Morus rubra.
t72........................  Queen palm...........  Arecastrum
                                                     romanzoffiamon.
t73........................  Australian pine......  Casuarina
                                                     equisetifolia.
t77........................  Oak mix (red, white,   Quercus spp.
                              black).
t80........................  Japanese cypress.....  Chamaecyparis
                                                     obtusa.
t81........................  Japanese alder.......  Alnus japonica.
t83........................  Mango tree...........  Mangifera indica.
t90........................  Walnut, black........  Juglans nigra.
t96........................  Poplar, white          Populus alba.
                              (poplar).
t103/t218..................  Virginia live oak      Quercus virginiana.
                              (live oak).
t105.......................  Pepper tree..........  Schinus molle.
t110.......................  Orange tree..........  Citrus sinensis.
t201.......................  Spruce, Norway spruce  Picea abies (Picea
                                                     excelsa).
t202.......................  Alder, smooth........  Alnus incana spp.
                                                     Rugosa (Alnus
                                                     rugosa).
t203.......................  Horse chestnut.......  Aesculus
                                                     hippocastanum.
t205.......................  Elder................  Sambucus nigra.
t206.......................  Chestnut.............  Castanea sativa.
t207.......................  Douglas fir..........  Pseudotsuga
                                                     menziesii
                                                     (Pseudotsuga
                                                     taxifolia).
t208.......................  Linden...............  Tilia cordata.
t209.......................  Horn beam............  Carpinus betulus.
t210.......................  Privet...............  Ligustrum vulgare.
t211.......................  Sweet gum............  Liquidambar
                                                     styraciflua.
t212.......................  Cedar................  Libocedrus
                                                     decurrens.
t213.......................  Pine.................  Pinus radiata.
t214.......................  Date palm............  Phoenix canariensis.
t215.......................  Lilac................  Syringa vulgaris.
t217.......................  Pepper tree..........  Schinus molle.
t217.......................  Red alder............  Alnus rubra.
t218.......................  Virginia live oak....  Quercus virginiana.
t218.......................  Bayberry (bayberry/    Myrica gale.
                              sweet gale).
t219.......................  Palo verde...........  Cercidium floridum.
t219.......................  Red cedar............  Juniperus
                                                     virginiana.
t220.......................  Bet v 4..............  Betula verrucosa
                                                     (Birch).
t221.......................  Bet v 2.0101, Bet v 4  Betula verrucosa
                                                     (Birch).
t222.......................  Cypress (Arizona       Cupressus arizonica.
                              cypress).
t223.......................  Oil palm.............  Elaeis guineensis.
t224.......................  Ole e 1..............  Olea europaea.
t225.......................  Bet v 6..............  Betula verrucosa
                                                     (Birch).
t226.......................  Cup a 1..............  Cupressus arizonica.
t227.......................  Ole e 7..............  Olea Europaea.
t228.......................  Aspen, quaking.......  Populus tremuloides.
t229.......................  Eastern hemlock......  Tsuga canadensis.
t230.......................  Redwood (sequoia)....  Sequoia
                                                     sempervirens.
t232.......................  Pussy willow.........  Salix discolor.
t240.......................  Ole e 9.0101.........  Olea Europaea.
t241.......................  Pla a 1.0101.........  Platanus acerifolia.

[[Page 13625]]

 
t242.......................  Pla a 2..............  Platanus acerifolia.
t243.......................  Pla a 3.0101.........  Platanus acerifolia.
t244.......................  Cor a 1.0103.........  Corylus avellana.
t245.......................  Aln g 1.0101.........  Alnus glutinosa.
t246.......................  Cry j 1..............  Cryptomeria
                                                     japonica.
t280.......................  Locust tree..........  Robinia
                                                     pseudoacacia.
t401.......................  Brazilian peppertree.  Schinus
                                                     terebinthifolius.
t402.......................  Mastic tree..........  Pistacia lentiscus.
t404.......................  Tree of heaven.......  Ailanthus altissima.
t406.......................  Date palm............  Phoenix dactylifera.
a482.......................  Ole e 1..............  Olea europaea (Olive
                                                     Oil).
------------------------------------------------------------------------
                                  Mites
------------------------------------------------------------------------
d207.......................  Blo t 5.0101.........  Blomia tropicalis.
d208.......................  Lep d 2.0101.........  Lepidoglyphus
                                                     destructor.
------------------------------------------------------------------------
                      Microorganisms, Molds, Yeast
------------------------------------------------------------------------
m1.........................  Penicillium            Penicillium
                              chrysogenum            chrysogenum
                              (Penicillium           (Penicillium
                              notatum).              notatum).
m2.........................  Cladosporium herbarum  Cladosporium
                              (Hormodendrum).        herbarum
                                                     (Hormodendrum).
m3.........................  Aspergillus fumigatus  Aspergillus
                                                     fumigatus.
m4.........................  Mucor racemosus......  Mucor racemosus.
m5.........................  Candida albicans.....  Candida albicans.
m7.........................  Botrytis cinerea.....  Botrytis cinerea.
m8.........................  Drechslera halodes     Drechslera halodes
                              (Setomelanomma         (Setomelanomma
                              rostrata,              rostrata,
                              Helminthosporium       Helminthosporium
                              halodes,               halodes).
                              Helminthosporium
                              interseminatum).
m9.........................  Fusarium moniliforme   Fusarium moniliforme
                              (Fusarium              (Fusarium
                              proliferatum).         proliferatum).
m10........................  Stemphylium botryosum  Stemphylium herbarum
                                                     (Stemphylium
                                                     botryosum).
m11........................  Rhizopus nigricans...  Rhizopus nigricans.
m12........................  Aureobasidium          Aureobasidium
                              pullulans.             pullulans.
m13........................  Phoma betae..........  Phoma betae.
m14........................  Epicoccum              Epicoccum
                              purpurascens.          purpurascens
                                                     (Epicoccum nigrum).
m15........................  Trichoderma viride...  Trichoderma viride.
m16........................  Curvularia lunata....  Curvularia lunata
                                                     Curvularia
                                                     specifera
                                                     (K923044).
m17........................  Cladosporium fulvum..  Cladosporium fulvum.
m18........................  Fusarium culmorum....  Fusarium culmorum.
m19........................  Aspergillus            Aspergillus
                              versicolor.            versicolor.
m20........................  Mucor mucedo.........  Mucor mucedo.
m21........................  Aspergillus clavatus.  Aspergillus
                                                     clavatus.
m22........................  Micropolyspora faeni.  Saccharopolyspora
                                                     rectivirgula
                                                     (Micropolyspora
                                                     faeni).
m23........................  Thermoactinomyces      Thermoactinomyces
                              vulgaris.              vulgaris.
m24........................  Stachybotrys atra....  Stachybotrys
                                                     chartarum
                                                     (Stachybotrys
                                                     atra).
m24........................  Paecilomyces spp.....  Paecilomyces spp.
m25........................  Aspergillus            Aspergillus
                              versicolor.            versicolor.
m25........................  Penicillium            Penicillium
                              brevicompactum.        brevicompactum.
m26........................  Cladosporium           Cladosporium
                              cladosporioides.       cladosporioides.
m26........................  Penicillium citrinum.  Penicillium
                                                     citrinum.
m27........................  Penicillium spp......  Penicillium spp.
m29........................  Aspergillus repens...  Aspergillus repens.
m30........................  Penicillium            Penicillium
                              roqueforti.            roqueforti.
m32........................  Cladosporium           Cladosporium
                              cladosporioides.       cladosporioides.
m34........................  Serpula lacrymans....  Serpula lacrymans.
m36........................  Aspergillus terreus..  Aspergillus terreus.
m37........................  Trichophyton           Trichophyton
                              mentagrophytes.        mentagrophytes.
m40........................  Aspergillus            Aspergillus
                              amstelodami.           amstelodami.
m43........................  Saccharomyces          Saccharomyces
                              carlsberg.             carlsbergensis.
m44........................  Saccharomyces          Saccharomyces
                              cerevisiae.            cerevisiae.
m45........................  Hormodendrum hordei..  Hormodendrum hordei.
m46........................  Bipolaris spicifera..  Bipolaris spicifera.
m47........................  Aspergillus nidulans.  Aspergillus
                                                     nidulans.
m48........................  Aspergillus oryzae...  Aspergillus oryzae.
m49........................  Fusarium oxysporum...  Fusarium oxysporum.
m50........................  Micropolyspora faeni.  Saccharopolyspora
                                                     rectivirgula
                                                     (Micropolyspora
                                                     faeni).
m51........................  Thermoactinomyces      Thermoactinomyces
                              vulgaris.              vulgaris.
m53........................  Microspora canis.....  Microsporum canis
                                                     (Microspora canis).
m54........................  Aspergillus flavus...  Aspergillus flavus.
m63........................  Helminthosporium       Helminthosporium
                              intersemin.            intersemin.
m66........................  Mucor plumbeus.......  Mucor plumbeus.

[[Page 13626]]

 
m67........................  Mycogone.............  Mycogone perniciosa.
m68........................  Nigrospora oryzae....  Nigrospora oryzae.
m69........................  Rhodotorula..........  Rhodotorula rubra
                                                     (Rhodotorula
                                                     mucilaginosa).
m70........................  Malassezia furfur      Malassezia furfur
                              (Pityrosporum          (Pityrosporum
                              orbiculare).           orbiculare).
m71........................  Spondylocladium......  Spondylocladium spp.
m72........................  Epidermophyton.......  Epidermophyton
                                                     floccosum.
m73........................  Epicoccum nigrum.....  Epicoccum
                                                     purpurascens
                                                     (Epicoccum nigrum).
m80........................  Staphylococcal         Staphylococcus
                              enterotoxin A (Sta a   aureus.
                              SEA).
m80........................  Helminthosporium spp.  Helminthosporium
                                                     spp.
m81........................  Staphylococcal         Staphylococcus
                              enterotoxin B (Sta a   aureus.
                              SEB).
m88........................  Stemphylium solani...  Stemphylium solani.
m93........................  Gliocladium            Gliocladium
                              fimbriatum.            fimbriatum.
m94........................  Phycomyces             Phycomyces
                              blakesleeanus.         blakesleeanus.
m201.......................  Tilletia tritici       Tilletia tritici
                              (Ustilago nuda,        (Ustilago nuda,
                              Ustilago tritici)      Ustilago tritici).
                              (Barley smut).
m202.......................  Acremonium kiliense    Acremonium kiliense
                              (Cephalosporium        (Cephalosporium
                              acremonium).           acremonium).
m203.......................  Trichosporon           Trichosporon
                              pullulans.             pullulans.
m204.......................  Ulocladium chartarum.  Ulocladium
                                                     chartarum.
m205.......................  Trichophyton rubrum..  Trichophyton rubrum.
m207.......................  Aspergillus niger....  Aspergillus niger.
m208.......................  Chaetomium globosum..  Chaetomium globosum.
m209.......................  Penicillium            Penicillium glabrum
                              frequentans.           (Penicillium
                                                     frequentans).
m209.......................  Stachybotrys           Stachybotrys
                              chartarum.             chartarum
                                                     (Stachybotrys
                                                     atra).
m210.......................  Trichophyton           Trichophyton
                              mentagrophytes var.    mentagrophytes var.
                              goetzii.               goetzii.
m211.......................  Trichophyton           Trichophyton
                              mentagrophytes var.    mentagrophytes var.
                              interdigitale.         interdigitale.
m211.......................  Oat smut.............  Ustilago avenae.
m212.......................  Micropolyspora faeni.  Saccharopolyspora
                                                     rectivirgula
                                                     (Micropolyspora
                                                     faeni).
m212.......................  Geotrichum candidum..  Geotrichum candidum.
m213.......................  Bermuda grass smut...  Ustilago cynodontis.
m214.......................  Johnson grass smut...  Sphacelotheca
                                                     cruenta.
m215.......................  Corn smut............  Ustilago maydis.
m218.......................  Asp f 1.0101.........  Aspergillus
                                                     fumigatus.
a3050......................  Asp r 1..............  Aspergillus
                                                     restrictus.
m219.......................  Asp f 2..............  Aspergillus
                                                     fumigatus.
m220.......................  Asp f 3.0101.........  Aspergillus
                                                     fumigatus.
m221.......................  Asp f 4..............  Aspergillus
                                                     fumigatus.
m222.......................  Asp f 6.0101.........  Aspergillus
                                                     fumigatus.
m223.......................  Staphylococal          Staphylococus
                              enterotoxin C (Sta a   aureus.
                              SEC).
m224.......................  Staphylococcal         Staphylococcus
                              enterotoxin D (Sta a   aureus.
                              SED).
m226.......................  Staphylococcal         Staphylococcus
                              enterotoxin TSST       aureus.
                              (Sta a TSST).
m227.......................  Malassezia spp.        Malassezia spp.
                              (Pityrosporum spp.).   (Pityrosporum
                                                     spp.).
m228.......................  Aspergillus flavus.    ....................
m229.......................  Alt a 1.0101.........  Alternaria alternata
                                                     (Alternaria
                                                     tenuis).
m230.......................  Alt a 6.0101.........  Alternaria alternata
                                                     (Alternaria
                                                     tenuis).
m231.......................  Cla h 8.0101.........  Cladosporium
                                                     herbarum
                                                     (Hormodendrum).
m300.......................  Eurotium spp.........  Eurotium spp.
m304.......................  Aspergillus oryzae...  Aspergillus oryzae.
m305.......................  Penicillium            Penicillium
                              brevicompactum.        brevicompactum.
m309.......................  Aspergillus terreus..  Aspergillus terreus.
m310.......................  Aspergillus nidulans.  Aspergillus
                                                     nidulans.
m311.......................  Aspergillus flavus...  Aspergillus flavus.
m312.......................  Aspergillus clavatus.  Aspergillus
                                                     clavatus.
------------------------------------------------------------------------
                           Epidermal & Animal
------------------------------------------------------------------------
e6.........................  Guinea pig epithelium  Cavia porcellus.
e7.........................  Pigeon droppings.....  Columba palumbus,
                                                     Columba livia.
e25........................  Chicken serum........  Gallus domesticus
                                                     (Gallus gallus
                                                     domesticus; Gallus
                                                     spp.).
e26........................  Parrot serum.........  Psittacoidea spp.
e62........................  Camel................  Camelus dromedaries.
e70........................  Goose feathers.......  Anser anser.
e71........................  Mouse epithelium.....  Mus musculus (Mus
                                                     spp.).
e73........................  Rat epithelium.......  Rattus norvegicus.
e74........................  Rat urine proteins...  Rattus norvegicus
                                                     Rattus rattus.
e75........................  Rat serum proteins...  Rattus norvegicus
                                                     Rattus rattus.
e76........................  Mouse serum proteins.  Mus musculus (Mus
                                                     spp.).
e77........................  Budgerigar droppings.  Melopsittacus
                                                     undulatus.
e78........................  Budgerigar feathers..  Melopsittacus
                                                     undulatus.
e79........................  Budgerigar serum       Melopsittacus
                              proteins.              undulatus.
e80........................  Goat epithelium......  Capra hircus.

[[Page 13627]]

 
e81........................  Sheep epithelium.....  Ovis aries (Ovis
                                                     spp.).
e82........................  Rabbit epithelium....  Oryctolagus
                                                     cuniculus
                                                     (Oryctolagus spp.).
e83........................  Swine epithelium.....  Sus scrofa (Sus
                                                     scrofa domesticus;
                                                     Sus spp.).
e84........................  Hamster epithelium...  Cricetus cricetus,
                                                     Mesocricetus
                                                     auratus, and
                                                     Phodopus sungorus.
e85........................  Chicken feathers.....  Gallus domesticus
                                                     (Gallus gallus
                                                     domesticus; Gallus
                                                     spp.).
e86........................  Duck feathers........  Anas platyrhynchos.
e87........................  Rat epithelium, serum  Rattus norvegicus
                              proteins, and urine    Rattus rattus.
                              proteins.
e88........................  Mouse epithelium,      Mus musculus (Mus
                              serum proteins, and    spp.).
                              urine proteins
                              (mouse).
e89........................  Turkey feathers......  Meleagris gallopavo.
e90........................  Budgerigar serum       Melopsittacus
                              proteins, feathers,    undulatus.
                              and droppings.
e91........................  Pigeon serum           Streptopelia
                              proteins, feathers,    roseogrisea
                              and droppings.         Psittacidae spp.
e92........................  Parrot serum           Ara spp.
                              proteins, feathers,
                              and droppings.
e93........................  Pigeon serum proteins  Streptopelia
                                                     roseogrisea.
e94........................  Fel d 1.0101.........  Felis domesticus.
a345.......................  Fel d 1..............  Felis domesticus.
e98........................  Parrot droppings.....  Psittacoidea spp.
e101.......................  Can f 1.0101.........  Canis familiaris
                                                     (Canis domesticus).
a174.......................  Can f 1..............  Canis familiaris
                                                     (Canis domesticus).
e102.......................  Can f 2.0101.........  Canis familiaris
                                                     (Canis domesticus).
e196.......................  Parakeet feathers....  Nymphicus
                                                     hollandicus.
e197.......................  Parakeet droppings...  Nymphicus
                                                     hollandicus.
e198.......................  Parakeet serum.......  Nymphicus
                                                     hollandicus.
e199.......................  Canary bird serum....  Serinus canarius.
e200.......................  Canary bird droppings  Serinus canarius.
e201.......................  Canary bird feathers   Serinus canarius.
                              (Canary feathers).
e202.......................  Reindeer epithelium..  Rangifer tarandus.
e203.......................  Mink epithelium......  Mustela spp.
e204.......................  Bos d 6..............  Bos domesticus (Bos
                                                     taurus; Bos spp.).
e205.......................  Horse, serum proteins  Equus caballus
                                                     (Equus spp.).
e206.......................  Rabbit, serum          Oryctolagus
                              proteins.              cuniculus
                                                     (Oryctolagus spp.).
e208.......................  Chinchilla epithelium  Chinchilla laniger.
e209.......................  Gerbil epithelium....  Meriones
                                                     unguiculatus.
e210.......................  Fox epithelium.......  Vulpes vulpes.
e211.......................  Rabbit, urine          Oryctolagus
                              proteins.              cuniculus
                                                     (Oryctolagus spp.).
e212.......................  Swine, urine proteins  Sus scrofa (Sus
                                                     scrofa domesticus;
                                                     Sus spp.).
e213.......................  Parrot feathers......  Ara spp.
e214.......................  Finch feathers.......  Lonchura domestica.
e215.......................  Pigeon feathers......  Streptopelia
                                                     roseogrisea
                                                     (Streptopelia
                                                     spp.), Columbia
                                                     spp.
e216.......................  Deer epithelium......  Dama dama.
e217.......................  Ferret epithelium....  Mustela putorius.
e218.......................  Chicken droppings....  Gallus domesticus
                                                     (Gallus gallus
                                                     domesticus; Gallus
                                                     spp.).
e219.......................  Chicken, serum         Gallus domesticus
                              proteins.              (Gallus gallus
                                                     domesticus; Gallus
                                                     spp.).
e220.......................  Fel d 2, Cat serum     Felis domesticus.
                              albumin.
e221.......................  Can f 3..............  Canis familiaris
                                                     (Canis domesticus)
                                                     (Dog serum
                                                     albumin).
e222.......................  Swine serum albumin    Sus scrofa (Sus
                              (Sus s PSA).           scrofa domesticus;
                                                     Sus spp.).
e225.......................  Lovebird feathers....  Psittacoidea
                                                     agapomis.
e226.......................  Can f 5.0101.........  Canis familiaris.
e227.......................  Equ c 1.0101.........  Equus caballus.
e228.......................  Fel d 4.0101.........  Felis domesticus.
e230.......................  Equ c 3..............  Equus caballus.
e231.......................  Mus m 1..............  Mus musculus.
------------------------------------------------------------------------
                                  Food
------------------------------------------------------------------------
f9.........................  Rice.................  Oryza sativa.
f12........................  Pea (green pea)......  Pisum sativum.
f15........................  White bean...........  Phaseolus vulgaris.
f19........................  Cayenne pepper.......  Capsicum frutescens,
                                                     (Capsicum annum).
f21........................  Sugar cane...........  Saccharum
                                                     officinarum.
f22........................  Raspberry............  Rubus idaeus.
f26........................  Pork.................  Sus scrofa (Sus
                                                     scrofa domesticus;
                                                     Sus spp.).
f29........................  Watermelon...........  Citrullus lanatus
                                                     (Citrullus
                                                     vulgaris).
f31........................  Carrot...............  Daucus carota.
f32........................  Oyster mushroom......  Pleurotus ostreatus.

[[Page 13628]]

 
f33........................  Orange...............  Citrus sinensis.
f35........................  Potato...............  Solanum tuberosum.
f43........................  Mother's milk........  Homo sapiens.
f44........................  Strawberry...........  Fragaria vesca
                                                     (Fragaria spp.).
f45........................  Yeast, baker's.......  Saccharomyces
                                                     cerevisiae.
f46........................  Pepper, Red..........  Capsicum annuum.
f47........................  Garlic...............  Allium sativum.
f48........................  Onion................  Allium cepa.
f49........................  Apple................  Malus x domestica
                                                     (Malus spp.).
f51........................  Bamboo shoot.........  Phyllostachys
                                                     pubescens.
f52........................  Cacao/chocolate......  Theobroma cacao.
f54........................  Sweet potato.........  Ipomoea batatas.
f55........................  Common millet........  Panicum miliaceum.
f56........................  Foxtail millet.......  Setaria italica.
f57........................  Japanese millet......  Echinochloa crus-
                                                     galli.
f58........................  Pacific squid........  Todarodes pacificus.
f59........................  Octopus..............  Octopus vulgaris
                                                     (Octopus spp.).
f63........................  Kefir................  NA.
f67........................  Parmesan cheese......  NA.
f81........................  Cheese, cheddar type.  NA.
f82........................  Cheese, mold type....  NA.
f83........................  Chicken..............  Gallus domesticus
                                                     (Gallus gallus
                                                     domesticus; Gallus
                                                     spp.).
f86........................  Parsley..............  Petroselinum
                                                     crispum.
f87........................  Melon................  Cucumis melo Cucumis
                                                     melo + Citrullus
                                                     lanatus.
f88........................  Mutton (lamb)........  Ovis aries (Ovis
                                                     spp.).
f90........................  Malt.................  Hordeum vulgare.
f92........................  Banana...............  Musa spp.
f93........................  Cacao................  Theobroma cacao.
f94........................  Pear.................  Pyrus communis
                                                     (Pyrus spp.).
f97........................  Yam..................  Dioscorea spp.,
                                                     Dioscorea opposita.
f97........................  Chamomile tea........  Matricaria
                                                     chamomilla.
f98........................  Gliadin..............  Triticum aestivum
                                                     (Triticum spp.).
f102.......................  Cantaloupe...........  Cucumis melo var.
                                                     cantalupensis.
f105.......................  Chocolate............  Theobroma cacao.
f109.......................  Cottonseed...........  Gossypium hirsutum.
f110.......................  Giant radish.........  Raphanus sativus.
f118.......................  Zucchini.............  Cucurbita pepo.
f119.......................  Radish...............  Raphanus sativus.
f120.......................  Venison..............  Capreolus capeolus.
f121.......................  Pinto bean...........  Phaseolus vulgaris.
f122.......................  Cheese, American.....  NA.
f127.......................  Black-eyed pea.......  Vigna unguiculata.
f131.......................  Black Olive..........  Olea europaea.
f136.......................  Red beet.............  Beta vulgaris var.
                                                     conditiva.
f139.......................  Goat's Cheese........  Capra aegagrus.
f140.......................  Bran.................  NA.
f141.......................  Corn (vegetables)....  Zea mays.
f152.......................  Green bell pepper....  Capsicum annuum.
f155.......................  Brewer's yeast.......  Saccharomyces
                                                     carlsbergensis.
f157.......................  Duck.................  Anas domesticus.
f158.......................  Goose................  Anser anser.
f160.......................  Camembert cheese.....  NA.
f162.......................  Nectarine............  Prunus persica var.
                                                     nucipersica.
f163.......................  Kohlrabi.............  Brassica oleracea
                                                     var. gongylodes.
f65........................  Perch                  ....................
f166.......................  Leek.................  Allium porrum.
f170.......................  Cheese (Switzerland)   NA.
                              (Swiss cheese).
f174.......................  Fig..................  Ficus carica.
f177.......................  Cranberry............  Vaccinium
                                                     macrocarpon.
f179.......................  Raisin...............  Vitis spp.
f182.......................  Lima bean............  Phaseolus lunatus.
f198.......................  Flaxseed (bruised      Linum usitatissimum.
                              grain).
f199.......................  Untreated native milk  Bos domesticus (Bos
                                                     taurus; Bos spp.).
f208.......................  Lemon................  Citrus limon.
f209.......................  Grapefruit...........  Citrus paradisi.
f210.......................  Pineapple............  Ananas comosus.
f211.......................  Blackberry...........  Rubus fruticosus.
f212.......................  Mushroom (champignon)  Agaricus hortensis
                                                     (Agaricus spp.).
f213.......................  Rabbit...............  Oryctolagus
                                                     cuniculus
                                                     (Oryctolagus spp.).

[[Page 13629]]

 
f214.......................  Spinach..............  Spinacia oleracea.
f215.......................  Lettuce..............  Lactuca sativa.
f216.......................  Cabbage..............  Brassica oleracea
                                                     var. capitata.
f217.......................  Brussels sprouts.....  Brassica oleracea
                                                     var. gem.
f218.......................  Paprika, sweet pepper  Capsicum annuum.
f219.......................  Fennel seed..........  Foeniculum vulgare.
f219.......................  Sage.................  Salvia officinalis.
f220.......................  Cinnamon.............  Cinnamomum spp.
f221.......................  Coffee...............  Coffea spp.
f222.......................  Tea..................  Camellia sinensis.
f223.......................  Green olive..........  Olea europaea.
f225.......................  Summer squash,         Cucurbita pepo.
                              pumpkin.
f225.......................  Pumpkin..............  Cucurbita maxima.
f226.......................  Pumpkin seed.........  Cucurbita pepo.
f227.......................  Sugar-beet seed......  Beta vulgaris.
f229.......................  Safflower Seed.......  Carthamus
                                                     tinctorius.
f231.......................  Milk, boiled.........  Bos domesticus (Bos
                                                     taurus; Bos spp.).
f234.......................  Vanilla..............  Vanilla planifolia.
f237.......................  Apricot..............  Prunus armeniaca.
f241.......................  Gouda cheese.........  NA.
f242.......................  Cherry...............  Prunus avium.
f244.......................  Cucumber.............  Cucumis sativus.
f246.......................  Guar, guar gum.......  Cyamopsis
                                                     tetragonoloba.
f247.......................  Honey................  NA.
f248.......................  Rosemary.............  Rosmarinus
                                                     officinalis.
f254.......................  Plaice...............  Pleuronectes
                                                     platessa.
f255.......................  Plum.................  Prunus domestica,
                                                     Prunus americana.
f258.......................  Squid................  Loligo spp.
f259.......................  Grape................  Vitis vinifera
                                                     (Vitis spp.).
f260.......................  Broccoli.............  Brassica oleracea
                                                     var. italica
                                                     (Brassica oleracea
                                                     var. cultivar).
f261.......................  Asparagus............  Asparagus
                                                     officinalis.
f262.......................  Aubergine, eggplant..  Solanum melongena.
f263.......................  Green pepper.........  Piper nigrum,
                                                     Capsicum annuum.
f264.......................  Eel..................  Anguilla anguilla.
f265.......................  Caraway..............  Carum carvi.
f265.......................  Cumin................  Cuminum cyminum.
f266.......................  Mace.................  Myristica fragrans.
f267.......................  Cardamon.............  Elettaria
                                                     cardamomum.
f268.......................  Clove................  Syzygium aromaticum.
f269.......................  Basil................  Ocimum basilicum.
f270.......................  Ginger...............  Zingiber officinale.
f271.......................  Anise................  Pimpinella anisum.
f272.......................  Tarragon.............  Artemisia
                                                     dracunculus.
f273.......................  Thyme................  Thymus vulgaris.
f274.......................  Marjoram.............  Origanum majorana.
f275.......................  Lovage...............  Levisticum
                                                     officinale.
f276.......................  Fennel, fresh........  Foeniculum vulgare.
f277.......................  Dill.................  Anethum graveolens.
f278.......................  Bay leaf.............  Laurus nobilis.
f279.......................  Chili pepper.........  Capsicum frutescens.
f280.......................  Black pepper.........  Piper nigrum.
f281.......................  Curry (Santa Maria)..  NA.
f282.......................  Nutmeg...............  Myristica fragrans.
f283.......................  Oregano..............  Origanum vulgare.
f284.......................  Turkey meat..........  Meleagris gallopavo.
f285.......................  Elk/moose meat.......  Alces spp.
f286.......................  Mare's milk..........  Equus caballus
                                                     (Equus spp.).
f287.......................  Red kidney bean......  Phaseolus vulgaris.
f288.......................  Blueberry............  Vaccinium myrtillus
                                                     (Vaccinium spp.).
f289.......................  Date.................  Phoenix dactylifera.
f291.......................  Cauliflower..........  Brassica oleracea
                                                     var. botrytis.
f292.......................  Guava................  Psidium guajava.
f293.......................  Papaya...............  Carica papaya.
f294.......................  Passion fruit,         Passiflora edulis
                              Maracuja.              (Passiflora spp.).
f295.......................  Carambola............  Averrhoa carambola.
f296.......................  Carob................  Ceratonia siliqua.
f297.......................  Gum arabic...........  Acacia senegal
                                                     (Acacia spp.).
f298.......................  Tragacanth...........  Astragalus spp.
f299.......................  Sweet chestnut         Castanea sativa.
                              (chestnut).

[[Page 13630]]

 
f300.......................  Pinto bean...........  Phaseolus spp.
f301.......................  Persimmon (kaki        Diospyros kaki.
                              fruit, sharon).
f302.......................  Mandarin (tangerine,   Citrus reticulata.
                              clementine,
                              satsumas).
f305.......................  Fenugreek............  Trigonella foenum-
                                                     graecum.
f306.......................  Lime.................  Citrus aurantifolia.
f307.......................  Hake.................  Merluccius
                                                     merluccius.
f308.......................  Sardine (pilchard)...  Sardina pilchardus.
f310.......................  Blue vetch...........  Lathyrus sativus.
f311.......................  Megrim...............  Lepidorhombus
                                                     whiffiagonis.
f315.......................  Green bean...........  Phaseolus vulgaris.
f316.......................  Rape seed............  Brassica napus.
f317.......................  Coriander............  Coriandrum sativum.
f318.......................  Jack fruit...........  Artocarpus
                                                     heterophyllus.
f319.......................  Beetroot.............  Beta vulgaris.
f320.......................  Crayfish.............  Astacus astacus.
f321.......................  Horse meat...........  Equus caballus
                                                     (Equus spp.).
f322.......................  Red currant..........  Ribes sylvestre.
f324.......................  Hop (fruit cone).....  Humulus lupulus.
f325.......................  Saffron..............  Colchicum autumnale.
f328.......................  Fig..................  Ficus carica.
f329.......................  Watermelon...........  Citrullus lanatus.
f330.......................  Rose hip.............  Rosa spp.
f331.......................  Saffron..............  Crocus sativus.
f332.......................  Mint.................  Mentha piperita.
f333.......................  Linseed..............  Linum usitatissimum.
f336.......................  Jujube...............  Ziziphus jujuba.
f336.......................  Wine vinegar.........  Vitis vinifera
                                                     (Vitis spp.).
f337.......................  Sole.................  Solea solea.
f337.......................  English sole.........  Parophrys vetulus.
f338.......................  Wine, white..........  Vitis vinifera
                                                     (Vitis spp.).
f339.......................  Allspice.............  Pimenta dioica.
f339.......................  Wine, red............  Vitis vinifera
                                                     (Vitis spp.).
f341.......................  Cranberry............  Vaccinium oxycoccus,
                                                     Vaccinium
                                                     macrocarpon.
f342.......................  Olive (black, fresh).  Olea europaea.
f343.......................  Raspberry............  Rubus idaeus.
f344.......................  Sage.................  Salvia officinalis.
f346.......................  Chives...............  Allium
                                                     schoenoprasum.
f347.......................  Quinoa...............  Chenopodium quinoa.
f348.......................  Litchi...............  Litchi chinensis.
f349.......................  Chum salmon roe......  Oncorhynchus keta.
f358.......................  Artichoke............  Cynara scolymus.
f360.......................  Yogurt...............  NA.
f368.......................  Black bass...........  Micropterus dolomieu
                                                     (Micropterus
                                                     dolomieui).
f374.......................  Karaya gum...........  Sterculia urens.
f375.......................  Horseradish..........  Armoracia rusticana.
f377.......................  Maple syrup..........  NA.
f379.......................  Okra.................  Abelmoschus
                                                     esculentus.
f382.......................  Beet, sugar..........  Beta vulgaris var.
                                                     altissima.
f401.......................  Loquat...............  Eriobotrya japonica.
f402.......................  Fig..................  Ficus carica.
f403.......................  Brewer's yeast.......  Saccharomyces
                                                     cerevisiae.
f405.......................  Mint.................  Mentha spp.
f406.......................  Arugula..............  Eruca vesicaria.
------------------------------------------------------------------------
                               House Dust
------------------------------------------------------------------------
h1.........................  Greer Labs., Inc.....  NA.
h2.........................  Hollister-Stier Labs.  NA.
h6.........................  Japan................  NA.
------------------------------------------------------------------------
                            Venoms & Insects
------------------------------------------------------------------------
i7.........................  Midge................  Chironomus
                                                     yoshimatsui.
i8.........................  Moth.................  Bombyx mori,
                                                     Heterocera spp.
i47........................  Water flea...........  Daphnia spp.
i49........................  Deer fly.............  Chrysops spp.
i51........................  Black ant............  Camponotus
                                                     pennsylvanicus.
i54........................  Flea mix (dog/cat),    Ctenocephalides spp.
                              common flea.
i71........................  Mosquito.............  Aedes communis,
                                                     Aedes spp. and
                                                     Culex spp.
i72........................  Green nimitti........  Cladotanytarsus
                                                     lewisi.

[[Page 13631]]

 
i73........................  Blood worm...........  Chironomus thummi,
                                                     Chironomusri
                                                     parius, Chironomus
                                                     spp.
i75........................  European hornet......  Vespa crabro.
i76........................  Berlin beetle........  Trogoderma angustum.
i77........................  European paper wasp..  Polistes dominulus.
i78........................  Fly..................  Musca domestica.
i80........................  Bumblebee............  Bombus
                                                     pennsylvanicus.
i201.......................  Horse bot fly........  Gasterophilus
                                                     intestinalis.
i202.......................  Grain weevil.........  Sitophilus
                                                     granarius.
i203.......................  Mediterranean flour    Ephestia kuehniella
                              moth.                  (Anagasta
                                                     kuehniella).
i204.......................  Horse fly............  Tabanus spp.
i205.......................  Bumblebee............  Bombus terrestris.
i208.......................  Api m 1.0101.........  Apis mellifera.
a45........................  Api m 1..............  Apis mellifera.
i209.......................  Ves v 5.0101.........  Vespula vulgaris.
a670.......................  Ves v 5..............  Vespula vulgaris.
i210.......................  Pol d 5.0101.........  Polistes dominulus.
i211.......................  Ves v 1.0101.........  Vespula vulgaris.
i213.......................  Api m 4..............  Apis mellifera.
i214.......................  Api m 2..............  Apis mellifera.
i215.......................  Api m 3..............  Apis mellifera.
i216.......................  Api m 5..............  Apis mellifera.
i217.......................  Api m 10.............  Apis mellifera.
i220.......................  Bla g 1.0101.........  Blattella germanica.
i221.......................  Bla g 2.0101.........  Blattella germanica.
i222.......................  Bla g 5.0101.........  Blattella germanica.
i223.......................  Bla g 7..............  Blattella germanica.
a46........................  Api m 2..............  Apis mellifera.
------------------------------------------------------------------------
                              Miscellaneous
------------------------------------------------------------------------
o1.........................  Cotton, crude fibers.  Gossypium spp.
o3.........................  Cotton (treated).....  Gossypium spp.
o70........................  Seminal fluid........  Homo sapiens.
o71........................  Staphylococcus aureus  Staphylococcus
                                                     aureus.
o72........................  Pichia pastoris crude  Pichia pastoris.
                              extract customer
                              specific.
o72........................  Sperm-sediment.......  Homo sapiens.
o73........................  Pichia pastoris crude  Pichia pastoris.
                              extr. vector
                              customer specific.
o74........................  Pichia pastoris with   Pichia pastoris.
                              vector customer
                              specific.
o201.......................  Tobacco leaf, tobacco  Nicotiana tabacum.
                              dust.
o202.......................  Artemia salina, fish   Artemia salina.
                              feed.
o203.......................  Tetramin, fish feed..  NA.
o207.......................  Daphnia, fish feed...  Daphnia spp.
o211.......................  Mealworm.............  Tenebrio molitor.
o212.......................  Streptavidin.........  Streptomyces
                                                     avidini.
o213.......................  MBP (maltose binding   Escherichia coli.
                              protein).
o214.......................  CCD; MUXF3 from        Ananas comosus.
                              bromelain.
o72........................  Enterotoxin A (Sta a   Staphylococcus
                              SEA).                  aureus.
o73........................  Enterotoxin B (Sta a   Staphylococcus
                              SEB).                  aureus.
------------------------------------------------------------------------
                                Parasites
------------------------------------------------------------------------
p1.........................  Ascaris..............  Ascaris suum.
p2.........................  Echinococcus.........  Echinococcus
                                                     granulosus.
p3.........................  Schistosoma..........  Schistosoma mansoni.
p4.........................  Anisakis (Herring      Anisakis simplex
                              Worm).                 (Anisakis spp.).
p5.........................  Toxocara canis.......  Toxocara canis.
p10........................  Ani s 3.0101.........  Anisakis simplex
                                                     (Anisakis spp.).
p11........................  Ani s 1..............  Anisakis simplex
                                                     (Anisakis spp.).
------------------------------------------------------------------------
                              Occupational
------------------------------------------------------------------------
k4.........................  Threshing dust.......  NA.
k5.........................  Flax.................  NA.
k7.........................  Hay Dust.............  NA.
k8.........................  Hop (hops)...........  Humulus lupulus.
k12........................  Grain mill dust......  NA.
k14........................  Kapok................  NA.
k20........................  Sheep's wool           Ovis aries (Ovis
                              (treated) (wool).      spp.).
k21........................  Sheep's wool           Ovis aries (Ovis
                              (Untreated).           spp.).

[[Page 13632]]

 
k23........................  Straw Dust...........  NA.
k33........................  Oak..................  NA.
k70........................  Green coffee bean....  Coffea spp.
k71........................  Castor bean..........  Ricinus communis.
k72........................  Ispaghula............  Plantago psyllium/
                                                     Plantago ovata.
k73........................  Silk waste...........  NA.
k74........................  Silk.................  Bombyx mori.
k75........................  Isocyanate TDI         NA.
                              (Toluene
                              diisocyanate).
k76........................  Isocyanate MDI         NA.
                              (Diphenylmethane
                              diisocyanate).
k77........................  Isocyanate HDI         NA.
                              (Hexamethylen
                              diisocyanate).
k78........................  Ethylene oxide.......  NA.
k79........................  Phthalic anhydride...  NA.
k80........................  Formaldehyde/Formalin  NA.
k81........................  Ficus................  Ficus benjamina
                                                     (Ficus spp.).
k83........................  Cotton seed..........  Gossypium hirsutum.
k84........................  Sunflower seed.......  Helianthus annuus.
k85........................  Chloramin T..........  NA.
k86........................  Trimellitic            NA.
                              anhydride, TMA.
k87........................  Asp o 21, alpha-       Aspergillus oryzae.
                              amylase.
k89........................  Orris root...........  Iris florentina.
k99........................  HSA (Human Serum       Homo sapiens.
                              Albumin) (Hom s HSA).
k201.......................  Car p 1, Papain......  Carica papaya.
k202.......................  Ana c 2, Bromelain...  Ananas comosus.
k204.......................  Maxatase.............  Bacillus
                                                     licheniformis.
k205.......................  Alcalase.............  Bacillus spp.
k206.......................  Savinase, Protease 1   Bacillus spp.
                              (Bac l Subtilisin).
k208.......................  Gal d 4, Lysozyme....  Gallus domesticus
                                                     (Gallus gallus
                                                     domesticus; Gallus
                                                     spp.).
k209.......................  Hexahydrophtalic       NA.
                              anhydrid.
k210.......................  Maleic anhydride.....  NA.
k211.......................  Methyltetrahydrophtal  NA.
                              ic anhydrid.
k212.......................  Abachi wood dust.....  Triplochiton
                                                     scleroxylon.
k213.......................  Pepsin (Sus s Pepsin)  Sus scrofa (Sus
                                                     scrofa domesticus;
                                                     Sus spp.).
k213.......................  TCPA.................  NA.
k214.......................  Bougainvillea........  Bougainvillea spp.
k225.......................  Horse radish           Armoracia rusticana.
                              peroxidase (Arm r
                              HRP).
k226.......................  Ascorbate oxidase      Cucurbita pepo.
                              (Cuc p ascorbate
                              oxidase).
k301.......................  Flour dust...........  Triticum spp.
k501.......................  Savinase customer      Proprietary
                              specific.              knowledge of
                                                     customer.
k502.......................  Lipolase customer      Proprietary
                              specific.              knowledge of
                                                     customer.
k503.......................  Termamyl customer      Proprietary
                              specific.              knowledge of
                                                     customer.
k504.......................  Clazinase customer     Proprietary
                              specific.              knowledge of
                                                     customer.
------------------------------------------------------------------------

V. Reference

    The following reference is on display in the Division of Dockets 
Management (see ADDRESSES) and is available for viewing by interested 
persons between 9 a.m. and 4 p.m., Monday through Friday; it is also 
available electronically at https://www.regulations.gov. FDA has 
verified the Web site address, as of the date this document publishes 
in the Federal Register, but Web sites are subject to change over time.

1. FDA Guidance, ``Procedures for Class II Device Exemptions from 
Premarket Notification, Guidance for Industry and CDRH Staff,'' 
February 19, 1998, available at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM080199.pdf.

    Dated: March 8, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-04938 Filed 3-13-17; 8:45 am]
 BILLING CODE 4164-01-P