35736 Federal Register / Vol. 61, No. 131 / Monday, July 8, 1996 / Notices

provisions in the Federal Deposit Insurance

Corporation Improvement Act of 1991.

Discussion Agenda

3. Proposed 1997 Federal Reserve Bank

budget objective.

4. Any items carried forward from a

previously announced meeting.

Note: This meeting will be recorded for the

benefit of those unable to attend. Cassettes

will be available for listening in the Board’s

Freedom of Information Office, and copies

may be ordered for $5 per cassette by calling

(202) 452–3684 or by writing to:

Freedom of Information Office, Board of

Governors of the Federal Reserve System,

Washington, D.C. 20551

CONTACT PERSON FOR MORE INFORMATION:

Mr. Joseph R. Coyne, Assistant to the

Board; (202) 452–3204.

Dated: July 3, 1996

Jennifer J. Johnson,

Deputy Secretary of the Board.

[FR Doc. 96–17402 Filed 7–03–96; 3:16 pm]

BILLING CODE 6210–01–P

Sunshine Act Meeting

AGENCY HOLDING THE MEETING: Board of

Governors of the Federal Reserve

System.

TIME AND DATE: Approximately 10:30

a.m., Wednesday, July 10, 1996,

following a recess at the conclusion of

the open meeting.

PLACE: Marriner S. Eccles Federal

Reserve Board Building, C Street

entrance between 20th and 21st Streets,

N.W., Washington, D.C. 20551.

STATUS: Closed.

MATTERS TO BE CONSIDERED:

1. Personnel actions (appointments,

promotions, assignments, reassignments, and

salary actions) involving individual Federal

Reserve System employees.

2. Any items carried forward from a

previously announced meeting.

CONTACT PERSON FOR MORE INFORMATION:

Mr. Joseph R. Coyne, Assistant to the

Board; (202) 452–3204. You may call

(202) 452–3207, beginning at

approximately 5 p.m. two business days

before this meeting, for a recorded

announcement of bank and bank

holding company applications

scheduled for the meeting.

Dated: July 3, 1996.

Jennifer J. Johnson,

Deputy Secretary of the Board.

[FR Doc. 96–17403 Filed 7–3–96; 3:16 pm]

BILLING CODE 6210–10–P

GENERAL SERVICES

ADMINISTRATION

[GSA Bulletin FPMR D–238]

Locating Federal Facilities on Historic

Properties in Our Nation’s Central

Cities

1. Purpose. This bulletin announces

the policy concerning the location of

Federal facilities on historic properties

in our central cities.

2. Expiration date. This bulletin

contains information of a continuing

nature and will remain in effect until

canceled.

3. Background. a. On May 21, 1996,

President Clinton signed Executive

Order 13006, entitled ‘‘Locating Federal

Facilities on Historic Properties in Our

Nation’s Central Cities,’’ to encourage

‘‘leasing, acquiring, locating,

maintaining, or managing’’ Federal

facilities on historic properties in our

nation’s central cities. So that federal

agencies may benefit from GSA’s real

property management expertise,

government-wide policy guidance is

being provided concerning the

acquisition and use of historic

properties to be utilized by federal

agencies where operationally

appropriate and economically prudent.

b. The Public Buildings Cooperative

Use Act of 1976 (40 U.S.C. 601a) directs

the Administrator of General Services to

‘‘acquire and utilize space in suitable

buildings of historic, architectural, or

cultural significance, unless use of such

space would not prove feasible and

prudent compared with available

alternatives.’’ In the past, some Federal

agencies have successfully promoted the

acquisition and use of space in

‘‘buildings of historic, architectural, and

cultural significance’’ by extending a 10

percent cost preference for these

properties.

4. Action. In accordance with

Executive Order 13006, and subject to

the requirements of section 601 of title

VI of the Rural Development Act of

1972, as amended, (42 U.S.C. 3122), and

Executive Order 12072, when locating

Federal facilities, Federal agencies shall

give first consideration to historic

properties within historic districts. If no

such property is suitable, then Federal

agencies shall consider other developed

or undeveloped sites within historic

districts. Federal agencies shall then

consider historic properties outside of

historic districts, if no suitable site

within a district exists.

All Federal agencies must use

procedures which implement the policy

to extend first consideration to locations

as prescribed in the Executive order.

These implementation procedures

should be consistent with the existing

policy set forth in Executive Order

12072 (Federal Space Management),

which extends first consideration to

central business areas (CBAs), and

should consider applicable

requirements relating to full and open

competition under the Competition in

Contracting Act, 41 U.S.C. 253 et seq.

Federal agencies are encouraged to

consider the Government’s previous

approach extending preference to

historic properties. Where operationally

appropriate and economically prudent,

Federal agencies may extend first

consideration to historic properties

using various methods, including but

not limited to extending a cost

preference (similar to GSAR 570.701–4,

Historic Preference); limiting

competition to historic districts and/or

historic properties; conducting market

surveys and market analyses to identify

historic properties or districts to be

included in the area of consideration;

providing notice of a requirement and

an opportunity to respond to local, state

or regional historic preservation

officials; or a combination of the

foregoing.

Dated: June 28, 1996.

G. Martin Wagner,

Associate Administrator, Office of Policy,

Planning and Evaluation.

[FR Doc. 96–17208 Filed 7–5–96; 8:45 am]

BILLING CODE 6820–23–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Centers for Disease Control and

Prevention

Notice of Specific List for

Categorization of Laboratory Test

Systems, Assays, and Examinations

by Complexity; Notice of Additional

Waived Laboratory Test Systems,

Assays, and Examinations; and Notice

of Announcement of Boards Approved

by HHS

AGENCY: Centers for Disease Control and

Prevention (CDC), HHS.

ACTION: Notice with comment period.

SUMMARY: Regulations codified at 42

CFR 493.17, implementing the Clinical

Laboratory Improvement Amendments

of 1988 (CLIA), Public Law 100–578,

require that the Secretary provide for

the categorization of specific laboratory

test systems, assays, and examinations

by level of complexity. The criteria for

such categorizations also are set forth in

those regulations.

This Notice announces the addition of

test systems to the waived category, and
Federal Register / Vol. 61, No. 131 / Monday, July 8, 1996 / Notices 35737

announces approximately 2400

additional test systems, assays, and

examinations that have been categorized

and notified between March 15, 1995

and June 7, 1996. These categorizations

were effective on the issue date of the

notification letter sent to the

manufacturer, and are subject to the 30

day comment period for this Notice.

This Notice also announces the

waiver of those test systems, assays, and

examinations that have met the CDC

guidelines reflected in the proposed

criteria for waiver as outlined in a

Notice of Proposed Rulemaking, 42 CFR

Part 493, HSQ–225–P, published

September 13, 1995, in the Federal

Register (60 FR 47534). These test

systems and test system instructions

may have been revised in order to meet

the criteria for waiver. Please contact

the manufacturer of the test system

regarding this information.

This Notice is published with an

opportunity for public comment. PHS

reserves the right to reevaluate and

recategorize a test based upon the

comments it receives in response to the

Federal Register notice.

In addition, this Notice announces

HHS approval of two certification

organizations, the American Board of

Histocompatibility and Immunogenetics

and the American Board of Medical

Genetics, for qualifying individuals as

laboratory directors and clinical

consultants.

DATES: Effective date: All

categorizations in this Notice were

effective on the date of the test

categorization notification letter sent to

the manufacturer. Written comments on

the tests initially categorized in this

Notice will be considered if they are

received at the address indicated below,

by no later than 5 p.m. on August 7,

1996. CDC reserves the right to

reevaluate and recategorize tests based

on the comments received in response

to this Notice.

ADDRESSES: Comments on the

categorization of tests in this Notice

should be addressed to Public Health

Service, Attention: CLIA Federal

Register Notice, Centers for Disease

Control and Prevention, Mail Stop F–11,

4770 Buford Highway, NE, Atlanta,

Georgia 30341–3724.

Requests for test complexity

categorization should be submitted to:

Attention: Test Categorization/CLIA,

Centers for Disease Control and

Prevention, Mail Stop F–11, 4770

Buford Highway, NE, Atlanta, Georgia

30341–3724.

Requests for waiver status should be

submitted to: Attention: Request for

Waiver Status/CLIA, Centers for Disease

Control and Prevention, Mail Stop F–11,

4770 Buford Highway, NE, Atlanta, GA

30341–3724.

Due to staffing and resource

limitations, we cannot accept facsimile

(FAX) copies of comments. Nor can we

accept comments by telephone.

FOR FURTHER INFORMATION CONTACT:

Rosemary C. Bakes-Martin, (770) 488–

7655.

SUPPLEMENTARY INFORMATION: All

requests for test categorization should

be submitted to the CDC. CDC is

reviewing submissions for test

categorization concurrently with the

FDA’s review process for 510(k)

clearance or PMA clearance. In order to

assure timely review by CDC,

manufacturers are requested to submit

the package insert and 510(k) number

for the product to CDC when the

product is submitted to the FDA.

However, CDC will not be able to issue

the test categorization until the FDA has

finished its review process. CDC is

currently issuing test categorization

notification letters to manufacturers

within one week of the FDA 510(k) or

Pre-Market Approval (PMA) clearance.

Test categorizations are effective as of

the date of notification to the applicant.

The CDC will publish updates and

revisions to the test categorization list

periodically in the Federal Register

with opportunity for comment. The CDC

will also maintain an updated list of

categorized tests electronically,

available to the public via Internet. For

further information regarding this

capability, please call (770) 488–7655.

Additions to the Waived Category

The CDC is evaluating requests for

waiver based on the guidelines for

submission of waiver requests that were

sent to manufacturers of laboratory

testing devices and other interested

parties through correspondence dated

December 19, 1994. These guidelines

reflect the proposed criteria for waiver

that are outlined in the Notice of

Proposed Rulemaking, 42 CFR Part 493,

HSQ–225–P, published September 13,

1995 in the Federal Register (60 FR

47534).

The following test systems have been

granted waived status based upon

meeting these guidelines: (25112)

HemoCue B-Glucose System for the

analyte (2203) glucose; (10170)

Cholestech L*D*X Test System for the

analytes (1020) cholesterol, (6118)

triglyceride, (2550) HDL cholesterol,

and (2203) glucose; (58338) Serim

PyloriTek Test Kit for the analyte (2512)

Helicobacter pylori; and (52036) Quidel

QuickVue In-Line One-Step Strep A

Test for the analyte (5828)

Streptococcus, group A (from throat

only).

This Notice also announces that the

(10165) ChemTrak AccuMeter, the

(31014) Johnson & Johnson ADVANCED

CARE Cholesterol Test, and the (07776)

Boehringer Mannheim Accu-Chek

InstantPlus Cholesterol for the analyte

(1020) Cholesterol have been granted

waived status following clearance by the

FDA for home use.

In this Notice we also are verifying

the complexity of two test system/

analyte combinations. The test system,

(04542) All Qualitative Color

Comparison pH Testing for the analyte

(0731) Body fluid (other than blood) pH,

is the same as the waived dipstick color

comparison products for qualitative pH

measurement in urine. Therefore, this

test system has been added to the list of

waived tests.

The second test system, (58217)

SmithKline Gastroccult for the analyte

(2211) Gastric Occult Blood, is the same

test system as that for fecal occult blood.

Therefore, this test system is also now

included on the list of waived

procedures.

Comments and Responses

On May 15, 1995, a test list of

approximately 3,000 additional test

systems, assays, and examinations

categorized by level of complexity was

published in the Federal Register (60

FR 25944) with a 30 day comment

period. Only one letter containing the

following general comments was

received in regard to this Notice.

Comment: The commenter expressed

concern about the categorization of

Growth/No Growth of Bacteria on Solid

Culture Media (22167) as a moderate

complexity test, and requested that this

test system be recategorized as high

complexity. The commenter used as an

example the primary plating of a

normally sterile joint fluid to a selective

medium, such as Thayer-Martin, if

Neisseria gonorrhoeae is suspected. The

commenter stated that if N. gonorrhoeae

were not present, Thayer-Martin may

inhibit the growth of other significant

organisms. If no other media had been

inoculated at the time the ThayerMartin was set up, the commenter

suggested that a ‘‘no growth’’ result

could incorrectly be reported.

Response: We disagree with the

commenter. In this case, the result that

should be reported is ‘‘no growth of N.

gonorrhoeae’’, since Thayer-Martin

media is selective for Neisseria

gonorrhoeae. Under CLIA, laboratories

are required to have protocols for the

primary inoculation of cultures from

specific sites to appropriate culture

media. It is the responsibility of the
35738 Federal Register / Vol. 61, No. 131 / Monday, July 8, 1996 / Notices

laboratory director to review and

approve these protocols. A normally

sterile joint fluid should be inoculated

to a combination of the appropriate

enriched, selective, and differential

media to permit isolation and enhance

the growth of any of a number of

possible aerobic or anaerobic organisms

that could be present in the fluid. For

this culture type, it would not be

appropriate to inoculate only ThayerMartin media.

Primary inoculation of any

microbiology culture media, in and of

itself, is not considered a complete test

system under the CLIA regulations, and

is not categorized for complexity. The

inoculation of the media becomes part

of the test system when the primary

media is observed to determine whether

growth is present after an incubation

period. It is the responsibility of the

testing personnel to evaluate the growth

or absence of growth. When solid

culture media is evaluated, the amount

of training, experience, interpretation,

and judgment required to determine if

any bacterial colonies are present,

results in a score that is in the moderate

complexity category. If, however, there

is any growth that must be interpreted,

or the medium being evaluated is a

broth or liquid medium, such as

thioglycollate, more training,

experience, interpretation, and

judgment is required, and the

examination scores as a high complexity

test.

Comment: The commenter requested

clarification of the categorization of

automated blood culture systems as

moderate complexity. This commenter

stated that although the loading and

monitoring of these automated analyzers

might be considered moderate

complexity, the analysis of positive

bottles detected on these instruments

should be categorized as high

complexity.

Response: We agree with the

commenter. The categorization of

automated blood culture systems as

moderate complexity includes only the

the loading and monitoring of these

instruments to detect microbial growth

in the bottles or vials. Once a signal for

growth is detected, the evaluation of the

growth, including Gram stain, and

subculturing to isolate and identify the

microorganism is the high complexity

test system ‘‘identification from

culture’’. On an automated blood

culture instrument, if a specimen does

not signal a positive result for growth,

the reporting of a negative result is

considered a moderate complexity test,

provided no followup testing is

performed.

Comment: Concern was expressed by

the commenter that an inadequate

response was provided in the May 15,

1995 Federal Register to a previous

comment on the question of

recategorization of ‘‘large’’ hematology

analyzers and microscopy procedures

from high to moderate complexity. The

commenter pointed out that the

complexity categorization should take

into account whether or not the

specimen being analyzed is a normal or

abnormal sample.

Response: We disagree with the

commenter that a ‘‘large’’ hematology

analyzer requires a higher complexity

categorization when the results of the

sample being processed are abnormal

rather than normal. The level of

technical expertise needed to operate

the analyzer does not vary with the

results produced as the results are

determined automatically by the

instrument. If the analyst chooses to

repeat those parameters of the

hematologic evaluation that are

considered to be abnormal, then the

repeat testing would be categorized

based upon the test methodology/

procedure employed.

The categorization of the microscopic

examination of a blood smear

(differential) does take into account

whether or not the cellular elements

present in the sample are those found in

normal peripheral blood. The manual

differential performed on a normal

blood smear requires the analyst to have

a general knowledge of cellular

morphology and maturation and is

categorized as moderate complexity,

whereas the manual differential

performed on an abnormal specimen

requires that the analyst have a

comprehensive knowledge of normal/

abnormal cellular morphology and

maturation and is categorized as high

complexity. A more detailed

explanation of categorization of blood

cell differentials can be found on page

39873 of the July 26, 1993 Federal

Register (58 FR 39873).

Corrections

The test system (07689)Bayer

GLUCOMETER ENCORE+ Blood

Glucose Meter has been added to the list

of waived procedures. This test system

was previously categorized as moderate

complexity. Recently, the FDA cleared

this test system for home use and

consequently it is now waived. Please

note there has been a change in

manufacturer name. This product was

formerly listed under Ames.

Test System and Analyte Nomenclature

Due to advances in technology, the

analyte (4024)Mycobacteria has been

refined, and specific analytes have been

designated for test systems that are used

to identify specific mycobacterial

organisms. These new analytes are:

(4008)Mycobacterium avium,

(4009)Mycobacterium avium complex,

(4011)Mycobacterium gordonae,

(4012)Mycobacterium intracellulare,

(4014)Mycobacterium kansasii, and

(4015)Mycobacterium tuberculosis

complex. While these more specific

analytes will replace the analyte

(4024)Mycobacteria in most instances,

the analyte (4024)Mycobacteria will

continue to be used with test systems

that are not used to identify a specific

mycobacterial organism.

Also due to technological advances, a

new analyte for thyroid stimulating

hormone, (6155)Thyroid Stimulating

Hormone (TSH) Third Generation, has

been designated for the test systems that

are able to detect this analyte.

As a point of clarification, an analyte

will be designated specifically as a

‘‘urine’’ analyte when a test procedure

requires a modification to the test

procedure for the urine analyte as

opposed to that required for the

‘‘serum’’ analyte.

Test System and Analyte Modifications

The development of new technology

in the specialty of microbiology has

necessitated a distinction in the

categorization of aerobic/anaerobic

culture identification (ID) and the

categorization of antimicrobial

susceptibility testing (AST). For

clarification, we are deleting the test

system (04372)All Organism ID and

Antimicrobial Susceptibility Testing,

and replacing it with two test systems

(04636)All Conventional Organism

Identification from Culture, and

(04637)All Antimicrobial Susceptibility

(disk diffusion/dilution) from Culture.

These two test systems will be assigned

to the analyte (0412)Aerobic &/or

Anaerobic Organisms—Unlimited

Sources, just as the previous test system

(04372) was listed. We realize that there

are a number of different techniques

used for the conventional methods of

identifying aerobic and anaerobic

organisms from culture; and that these

identification methods can be quite

different from the processes used to

perform standardized disk diffusion,

agar or broth dilution antimicrobial

susceptibility testing from culture.

Although identification and

susceptibility testing from culture are

often performed together, they are

distinct methods that may be done

independently. In an effort to be

specific, we are separating the two tests.
Federal Register / Vol. 61, No. 131 / Monday, July 8, 1996 / Notices 35739

Dated: June 28, 1996.

David Satcher,

Director, Centers for Disease Control and

Prevention (CDC).

List of Previously Unpublished

Categorizations

The test categorization scoring

scheme was based on an assessment of

the complexity of the operation of the

test procedure and not on an evaluation

of data documenting the procedure’s

performance over time. Therefore, the

categorization of a test system, assay or

examination as moderate or high

complexity should not be interpreted as

an indication of the acceptability or

unacceptability of the accuracy,

precision or overall performance of the

procedure.

Complexity: Moderate

Speciality/Subspeciality: Bacteriology

Analyte: Aerobic Organisms From Urine

Specimens Only (0468)

Test System, Assay, Examination:

Culture Kits, Inc. Uri-Two (colony count

only) (10332)

Analyte: Chlamydia (1016)

Test System, Assay, Examination:

BioStar Chlamydia OIA (direct antigen/

visual) (07641)

Johnson & Johnson CDI SureCell (direct

antigen/visual) (31063)

Quidel QuickVue Chlamydia Test (direct

antigen/visual) (52026)

Analyte: Helicobacter Pylori (2512)

Test System, Assay, Examination:

GI Supply HP–FAST (22175)

Analyte: Streptococcus, Group A (5810)

Test System, Assay, Examination:

Abbott TestPack +Plus Strep A with OBC

(dir. Ag/visual) (04625)

Applied Biotech SureStep Strep A Test (dir

antigen/visual) (04559)

Johnson & Johnson CDI SureCell (direct

antigen/visual) (31063)

Analyte: Streptococcus, Group A (From

Throat Only) (5828)

Test System, Assay, Examination:

Binax Strep A Test (direct antigen/visual)

(07684)

Henry Schein OneStep Strep A Test

(25258)

Medix Biotech Contrast Strep A (40223)

Medix Biotech FAStrep A (40225)

Medix Biotech Rapid Strep A (40222)

Orion Diagnostica UniStep Strep A (46194)

Quidel CARDS Q.S. Strep A (52035)

Quidel Concise Performance Plus Strep A

(52034)

Syntron Bioresearch QuikStrip OneStep

Strep A Strip Test (58384)

Syntron QuikPac II OneStep Strep A

(58316)

Analyte: Vibrio cholerae (6716)

Test System, Assay, Examination:

New Horizons Cholera SMART (43088)

Speciality/Subspeciality: Endocrinology

Analyte: Adrenocorticotropic Hormone

(ACTH) (0458)

Test System, Assay, Examination:

Cirrus Diagnostics Immulite (10159)

Analyte: Cortisol (1032)

Test System, Assay, Examination:

TOSOH A1A–1200 (61040)

TOSOH A1A–1200DX (61154)

TOSOH A1A–600 (61039)

Analyte: Cortisol, Urine (direct procedure)

(1033)

Test System, Assay, Examination:

Ciba Corning ACS 180 (10046)

Analyte: Estradiol (1605)

Test System, Assay, Examination:

Organon Teknika AuraFlex (46152)

Technicon Immuno 1 System (61042)

Analyte: HCG, Serum, Qualitative (2501)

Test System, Assay, Examination:

Boehringer Mannheim AccuStat hCG/

Diluent Reagent (07775)

Excel Scientific OneStep Urine/Serum hCG

Preg Module Test (16133)

Horizon Diagnostics Pregna-Plus hCG

(25225)

Johnson & Johnson CDI SureCell hCGUrine/Serum (31066)

Medix Biotech CONTRAST hCG Urine/

Serum Test (40215)

Medix Biotech Rapid hCG (urine/serum)

(40224)

TCPI One Step Pregnancy hCG/Diluent

Reagent (61234)

Worldwide Medical First Check hCG

(cassette) (70181)

Wyntek Diagnostics OSOM hCG-Combo

Test (70177)

Analyte: HCG, Total, Serum, Quantitative

(2555)

Test System, Assay, Examination:

Organon Teknika AuraFlex (46152)

Analyte: HCG, Urine, Qualitative (nonwaived procedures) (2503)

Test System, Assay, Examination:

Immunostics immuno/cept-d (28429)

Immunostics immuno/cept-d Monoclonal

Beta (28428)

Organon Teknika AuraFlex (46152)

Analyte: HCG, Urine, Quantitative (2534)

Test System, Assay, Examination:

PB Diagnostics Systems OPUS (49001)

PB Diagnostics Systems OPUS Magnum

(49097)

PB Diagnostics Systems OPUS PLUS

(49098)

Analyte: Human Growth Hormone (GH)

(2547)

Test System, Assay, Examination:

Cirrus Diagnostics Immulite (10159)

Analyte: Human Placental Lactogen (hPL)

(2533)

Test System, Assay, Examination:

Cirrus Diagnostics Immulite (10159)

Analyte: Insulin (2812)

Test System, Assay, Examination:

Sanofi Pasteur Access Immunoassay

System (58257)

Analyte: Progesterone (4914)

Test System, Assay, Examination:

Abbott AxSYM (04532)

Organon Teknika AuraFlex (46152)

Sanofi Pasteur Access Immunoassay

System (58257)

Technicon Immuno 1 System (61042)

Analyte: Prolactin (4915)

Test System, Assay, Examination:

Organon Teknika AuraFlex (46152)

Analyte: Sex Hormone Binding Globulin

(5819)

Test System, Assay, Examination:

Cirrus Diagnostics Immulite (10159)

Analyte: T Uptake (TU) (6156)

Test System, Assay, Examination:

Boehringer Mannheim Hitachi 704 (07161)

Boehringer Mannheim Hitachi 717 (07163)

Boehringer Mannheim Hitachi 736 (07164)

Boehringer Mannheim Hitachi 737 (07165)

Boehringer Mannheim Hitachi 747 (07166)

Boehringer Mannheim Hitachi 911 (07377)

Boehringer Mannheim Hitachi 914 (07546)

Boehringer Mannheim Hitachi 917 (07765)

Ciba Corning 550 Express (10038)

Olympus AU 800 (46110)

Olympus Reply (46089)

Roche Cobas Mira (55044)

Analyte: Thyroid Stimulating Hormone

(TSH) (6106)

Test System, Assay, Examination:

Franklin Diagnostics ThyroChek One-Step

Rapid TSH (19025)

Analyte: Thyroid Stimulating Hormone

(TSH) Third Generation (6155)

Test System, Assay, Examination:

Cirrus Diagnostics Immulite (10159)

Analyte: Thyroid Stimulating Hormone—

High Sens. (TSH–HS) (6108)

Test System, Assay, Examination:

Abbott AxSYM (04532)

Analyte: Thyroxine (T4) (6109)

Test System, Assay, Examination:

Beckman Synchron CX 4 Delta (07762)

Beckman Synchron CX 5 Delta (07763)

Beckman Synchron CX 7 Delta (07764)

Bio-Chem Laboratory Systems ATAC 8000

(07658)

Bio-Rad RADIAS System (07493)

Biocircuits IOS (07745)

Boehringer Mannheim Hitachi 917 (07765)

Roche Cobas INTEGRA (55179)

Analyte: Thyroxine (T4), Neonatal (6123)

Test System, Assay, Examination:

Bio-Rad RADIAS System (07493)

Analyte: Thyroxine Binding Globulin (TBG)

(6110)

Test System, Assay, Examination:

Cirrus Diagnostics Immulite (10159)

Analyte: Thyroxine Uptake (T4U) (TU)

(6139)

Test System, Assay, Examination:

Abbott AxSYM (04532)

Biocircuits IOS (07745)
35740 Federal Register / Vol. 61, No. 131 / Monday, July 8, 1996 / Notices

Analyte: Thyroxine, Free (FT4) (6111)

Test System, Assay, Examination:

PB Diagnostics Systems OPUS Magnum

(49097)

PB Diagnostics Systems OPUS PLUS

(49098)

Analyte: Triiodothyronine Uptake (T3U)

(TU) (6120)

Test System, Assay, Examination:

Beckman Synchron CX 4 Delta (07762)

Beckman Synchron CX 5 Delta (07763)

Beckman Synchron CX 7 Delta (07764)

Bio-Chem Laboratory Systems ATAC 8000

(07658)

Roche Cobas INTEGRA (55179)

Analyte: Triiodothyronine, Free (FT3) (6121)

Test System, Assay, Examination:

Roche Cobas Core Automated System

(55119)

Sanofi Pasteur Access Immunoassay

System (58257)

Speciality/Subspeciality: General

Chemistry

Analyte: Acid Phosphatase (0407)

Test System, Assay, Examination:

Instrumentation Laboratory ILAB 1800

(28323)

Instrumentation Laboratory ILAB 900

(28322)

Johnson & Johnson CDI Ektachem 250

(31019)

Johnson & Johnson CDI Ektachem 500

(31021)

Johnson & Johnson CDI Ektachem 550 XRC

(31022)

Johnson & Johnson CDI Ektachem 700

(31023)

Johnson & Johnson CDI Ektachem 700

Analyzer C Series (31024)

Johnson & Johnson CDI Ektachem 700 XR

(31026)

Johnson & Johnson CDI Ektachem 750 XRC

(31027)

Johnson & Johnson CDI Ektachem 950 IRC

(31028)

Johnson & Johnson CDI Ektachem DT II

(31030)

Analyte: Alanine Aminotransferase (ALT)

(SGPT) (0404)

Test System, Assay, Examination:

Abaxis Piccolo Portable Blood Analyzer

(04608)

Beckman Synchron CX 4 Delta (07762)

Beckman Synchron CX 5 Delta (07763)

Beckman Synchron CX 7 Delta (07764)

Bio-Chem Laboratory Systems ATAC 8000

(07658)

Boehringer Mannheim Hitachi 917 (07765)

Johnson & Johnson CDI Ektachem 250

(31019)

Johnson & Johnson CDI Ektachem 500

(31021)

Johnson & Johnson CDI Ektachem 550 XRC

(31022)

Johnson & Johnson CDI Ektachem 700

(31023)

Johnson & Johnson CDI Ektachem 700

Analyzer C Series (31024)

Johnson & Johnson CDI Ektachem 700 P

(31025)

Johnson & Johnson CDI Ektachem 700 XR

(31026)

Johnson & Johnson CDI Ektachem 750 XRC

(31027)

Johnson & Johnson CDI Ektachem 950 IRC

(31028)

Johnson & Johnson CDI Ektachem DT II

(31030)

Johnson & Johnson CDI Ektachem DT SC

Module (31031)

Roche Cobas INTEGRA (55179)

Select Medical Systems Selecta 20/60

(58349)

Analyte: Albumin (0414)

Test System, Assay, Examination:

Abaxis Piccolo Portable Blood Analyzer

(04608)

Beckman Synchron CX 4 Delta (07762)

Beckman Synchron CX 5 Delta (07763)

Beckman Synchron CX 7 Delta (07764)

Bio-Chem Laboratory Systems ATAC 8000

(07658)

Boehringer Mannheim Hitachi 917 (07765)

Johnson & Johnson CDI Ektachem 250

(31019)

Johnson & Johnson CDI Ektachem 400

(31020)

Johnson & Johnson CDI Ektachem 500

(31021)

Johnson & Johnson CDI Ektachem 550 XRC

(31022)

Johnson & Johnson CDI Ektachem 700

(31023)

Johnson & Johnson CDI Ektachem 700

Analyzer C Series (31024)

Johnson & Johnson CDI Ektachem 700 P

(31025)

Johnson & Johnson CDI Ektachem 700 XR

(31026)

Johnson & Johnson CDI Ektachem 750 XRC

(31027)

Johnson & Johnson CDI Ektachem 950 IRC

(31028)

Johnson & Johnson CDI Ektachem DT II

(31030)

Johnson & Johnson CDI Ektachem DT SC

Module (31031)

Roche Cobas INTEGRA (55179)

Select Medical Systems Selecta 20/60

(58349)

Analyte: Alkaline Phosphatase (ALP) (0416)

Test System, Assay, Examination:

Abaxis Piccolo Portable Blood Analyzer

(04608)

Beckman Synchron CX 4 Delta (07762)

Beckman Synchron CX 5 Delta (07763)

Beckman Synchron CX 7 Delta (07764)

Bio-Chem Laboratory Systems ATAC 8000

(07658)

Boehringer Mannheim Hitachi 917 (07765)

Johnson & Johnson CDI Ektachem 250

(31019)

Johnson & Johnson CDI Ektachem 400

(31020)

Johnson & Johnson CDI Ektachem 500

(31021)

Johnson & Johnson CDI Ektachem 550 XRC

(31022)

Johnson & Johnson CDI Ektachem 700

(31023)

Johnson & Johnson CDI Ektachem 700

Analyzer C Series (31024)

Johnson & Johnson CDI Ektachem 700 P

(31025)

Johnson & Johnson CDI Ektachem 700 XR

(31026)

Johnson & Johnson CDI Ektachem 750 XRC

(31027)

Johnson & Johnson CDI Ektachem 950 IRC

(31028)

Johnson & Johnson CDI Ektachem DT II

(31030)

Johnson & Johnson CDI Ektachem DT SC

Module (31031)

Roche Cobas INTEGRA (55179)

Select Medical Systems Selecta 20/60

(58349)

Analyte: Alpha-Hydroxybutyrate

Dehydrogenase (HBDH) (0419)

Test System, Assay, Examination:

Beckman Synchron CX 4 Delta (07762)

Beckman Synchron CX 5 Delta (07763)

Beckman Synchron CX 7 Delta (07764)

Analyte: Ammonia, Plasma/Serum (0427)

Test System, Assay, Examination:

Beckman Synchron CX 4 Delta (07762)

Beckman Synchron CX 5 Delta (07763)

Beckman Synchron CX 7 Delta (07764)

Boehringer Mannheim Hitachi 917 (07765)

Johnson & Johnson CDI Ektachem 250

(31019)

Johnson & Johnson CDI Ektachem 400

(31020)

Johnson & Johnson CDI Ektachem 500

(31021)

Johnson & Johnson CDI Ektachem 550 XRC

(31022)

Johnson & Johnson CDI Ektachem 700

(31023)

Johnson & Johnson CDI Ektachem 700

Analyzer C Series (31024)

Johnson & Johnson CDI Ektachem 700 P

(31025)

Johnson & Johnson CDI Ektachem 700 XR

(31026)

Johnson & Johnson CDI Ektachem 750 XRC

(31027)

Johnson & Johnson CDI Ektachem 950 IRC

(31028)

Johnson & Johnson CDI Ektachem DT 60

(31029)

Johnson & Johnson CDI Ektachem DT II

(31030)

Analyte: Amylase (0429)

Test System, Assay, Examination:

Abaxis Piccolo Portable Blood Analyzer

(04608)

Beckman Synchron CX 4 Delta (07762)

Beckman Synchron CX 5 Delta (07763)

Beckman Synchron CX 7 Delta (07764)

Bio-Chem Laboratory Systems ATAC 8000

(07658)

Boehringer Mannheim Hitachi 917 (07765)

Johnson & Johnson CDI Ektachem 250

(31019)

Johnson & Johnson CDI Ektachem 400

(31020)

Johnson & Johnson CDI Ektachem 500

(31021)

Johnson & Johnson CDI Ektachem 550 XRC

(31022)

Johnson & Johnson CDI Ektachem 700

(31023)

Johnson & Johnson CDI Ektachem 700

Analyzer C Series (31024)

Johnson & Johnson CDI Ektachem 700 P

(31025)

Johnson & Johnson CDI Ektachem 700 XR

(31026)
Federal Register / Vol. 61, No. 131 / Monday, July 8, 1996 / Notices 35741

Johnson & Johnson CDI Ektachem 750 XRC

(31027)

Johnson & Johnson CDI Ektachem 950 IRC

(31028)

Johnson & Johnson CDI Ektachem DT 60

(31029)

Johnson & Johnson CDI Ektachem DT II

(31030)

Roche Cobas INTEGRA (55179)

Select Medical Systems Selecta 20/60

(58349)

Analyte: Amylase, Pancreatic Isoenzymes (pAmylase) (0500)

Test System, Assay, Examination:

Beckman Synchron CX 4 Delta (07762)

Beckman Synchron CX 5 Delta (07763)

Beckman Synchron CX 7 Delta (07764)

Boehringer Mannheim Hitachi 917 (07765)

Analyte: Apolipoprotein A1 (0462)

Test System, Assay, Examination:

Bio-Chem Laboratory Systems ATAC 8000

(07658)

Roche Cobas INTEGRA (55179)

Wako Diagnostics 30R (70002)

Analyte: Apolipoprotein B (0457)

Test System, Assay, Examination:

Bio-Chem Laboratory Systems ATAC 8000

(07658)

Roche Cobas INTEGRA (55179)

Analyte: Aspartate Aminotransferase (AST)

(SGOT) (0405)

Test System, Assay, Examination:

Abaxis Piccolo Portable Blood Analyzer

(04608)

Beckman Synchron CX 4 Delta (07762)

Beckman Synchron CX 5 Delta (07763)

Beckman Synchron CX 7 Delta (07764)

Bio-Chem Laboratory Systems ATAC 8000

(07658)

Boehringer Mannheim Hitachi 917 (07765)

Johnson & Johnson CDI Ektachem 250

(31019)

Johnson & Johnson CDI Ektachem 500

(31021)

Johnson & Johnson CDI Ektachem 550 XRC

(31022)

Johnson & Johnson CDI Ektachem 700

(31023)

Johnson & Johnson CDI Ektachem 700

Analyzer C Series (31024)

Johnson & Johnson CDI Ektachem 700 P

(31025)

Johnson & Johnson CDI Ektachem 700 XR

(31026)

Johnson & Johnson CDI Ektachem 750 XRC

(31027)

Johnson & Johnson CDI Ektachem 950 IRC

(31028)

Johnson & Johnson CDI Ektachem DT II

(31030)

Johnson & Johnson CDI Ektachem DT SC

Module (31031)

Roche Cobas INTEGRA (55179)

Select Medical Systems Selecta 20/60

(58349)

Analyte: Bilirubin, Direct (0704)

Test System, Assay, Examination:

Abaxis Piccolo Portable Blood Analyzer

(04608)

Beckman Synchron CX 4 Delta (07762)

Beckman Synchron CX 5 Delta (07763)

Beckman Synchron CX 7 Delta (07764)

Bio-Chem Laboratory Systems ATAC 8000

(07658)

Boehringer Mannheim Hitachi 917 (07765)

Johnson & Johnson CDI Ektachem 250

(31019)

Johnson & Johnson CDI Ektachem 400

(31020)

Johnson & Johnson CDI Ektachem 500

(31021)

Johnson & Johnson CDI Ektachem 550 XRC

(31022)

Johnson & Johnson CDI Ektachem 700

(31023)

Johnson & Johnson CDI Ektachem 700

Analyzer C Series (31024)

Johnson & Johnson CDI Ektachem 700 P

(31025)

Johnson & Johnson CDI Ektachem 700 XR

(31026)

Johnson & Johnson CDI Ektachem 750 XRC

(31027)

Johnson & Johnson CDI Ektachem 950 IRC

(31028)

Roche Cobas INTEGRA (55179)

Analyte: Bilirubin, Neonatal (0705)

Test System, Assay, Examination:

Johnson & Johnson CDI Ektachem 250

(31019)

Johnson & Johnson CDI Ektachem 400

(31020)

Johnson & Johnson CDI Ektachem 500

(31021)

Johnson & Johnson CDI Ektachem 550 XRC

(31022)

Johnson & Johnson CDI Ektachem 700

(31023)

Johnson & Johnson CDI Ektachem 700

Analyzer C Series (31024)

Johnson & Johnson CDI Ektachem 700 P

(31025)

Johnson & Johnson CDI Ektachem 700 XR

(31026)

Johnson & Johnson CDI Ektachem 750 XRC

(31027)

Johnson & Johnson CDI Ektachem DT 60

(31029)

Johnson & Johnson CDI Ektachem DT II

(31030)

Analyte: Bilirubin, Total (0706)

Test System, Assay, Examination:

Abaxis Piccolo Portable Blood Analyzer

(04608)

Beckman Synchron CX 4 Delta (07762)

Beckman Synchron CX 5 Delta (07763)

Beckman Synchron CX 7 Delta (07764)

Bio-Chem Laboratory Systems ATAC 8000

(07658)

Boehringer Mannheim Hitachi 917 (07765)

Johnson & Johnson CDI Ektachem 250

(31019)

Johnson & Johnson CDI Ektachem 400

(31020)

Johnson & Johnson CDI Ektachem 500

(31021)

Johnson & Johnson CDI Ektachem 550 XRC

(31022)

Johnson & Johnson CDI Ektachem 700

(31023)

Johnson & Johnson CDI Ektachem 700

Analyzer C Series (31024)

Johnson & Johnson CDI Ektachem 700 P

(31025)

Johnson & Johnson CDI Ektachem 700 XR

(31026)

Johnson & Johnson CDI Ektachem 750 XRC

(31027)

Johnson & Johnson CDI Ektachem 950 IRC

(31028)

Johnson & Johnson CDI Ektachem DT 60

(31029)

Johnson & Johnson CDI Ektachem DT II

(31030)

Roche Cobas INTEGRA (55179)

Analyte: Blood Gases With pH (0708)

Test System, Assay, Examination:

AVL OMNI Combi Analyzer (04609)

Instrumentation Laboratory IL BGGE (IL

1660) (28438)

Nova Stat Profile Ultra A (43108)

Nova Stat Profile Ultra B (43109)

Nova Stat Profile Ultra C (43110)

Nova Stat Profile Ultra D (43111)

Nova Stat Profile Ultra E (43112)

Nova Stat Profile Ultra F (43115)

Nova Stat Profile Ultra G (43116)

Nova Stat Profile Ultra H (43117)

Nova Stat Profile Ultra I (43118)

Nova Stat Profile Ultra J (43119)

Nova Stat Profile Ultra K (43120)

Radiometer ABL System 605 (55196)

Radiometer ABL System 615 (55197)

Radiometer ABL System 625 (55198)

SenDx 100 pH, Blood Gas and Electrolyte

Analysis System (58390)

Analyte: Blood pH (No Blood Gases) (0721)

Test System, Assay, Examination:

Radiometer BPH5 Blood pH System

(55158)

Analyte: C-Peptide (1040)

Test System, Assay, Examination:

Cirrus Diagnostics Immulite (10159)

TOSOH A1A–1200 (61040)

TOSOH A1A–1200DX (61154)

TOSOH A1A–600 (61039)

Analyte: Calcium, Ionized (1004)

Test System, Assay, Examination:

AVL OMNI Combi Analyzer (04609)

Nova Stat Profile Ultra B (43109)

Nova Stat Profile Ultra C (43110)

Nova Stat Profile Ultra I (43118)

Nova Stat Profile Ultra J (43119)

Nova Stat Profile Ultra K (43120)

Radiometer ABL System 605 (55196)

Radiometer ABL System 615 (55197)

Radiometer ABL System 625 (55198)

Radiometer EML 105 (55187)

SenDx 100 pH, Blood Gas and Electrolyte

Analysis System (58390)

Analyte: Calcium, Total (1005)

Test System, Assay, Examination:

Abaxis Piccolo Portable Blood Analyzer

(04608)

Beckman Synchron CX 4 Delta (07762)

Beckman Synchron CX 5 Delta (07763)

Beckman Synchron CX 7 Delta (07764)

Bio-Chem Laboratory Systems ATAC 8000

(07658)

Boehringer Mannheim Hitachi 917 (07765)

Johnson & Johnson CDI Ektachem 250

(31019)

Johnson & Johnson CDI Ektachem 400

(31020)

Johnson & Johnson CDI Ektachem 500

(31021)

Johnson & Johnson CDI Ektachem 550 XRC

(31022)
35742 Federal Register / Vol. 61, No. 131 / Monday, July 8, 1996 / Notices

Johnson & Johnson CDI Ektachem 700

(31023)

Johnson & Johnson CDI Ektachem 700

Analyzer C Series (31024)

Johnson & Johnson CDI Ektachem 700 P

(31025)

Johnson & Johnson CDI Ektachem 700 XR

(31026)

Johnson & Johnson CDI Ektachem 750 XRC

(31027)

Johnson & Johnson CDI Ektachem 950 IRC

(31028)

Johnson & Johnson CDI Ektachem DT II

(31030)

Johnson & Johnson CDI Ektachem DT SC

Module (31031)

Roche Cobas INTEGRA (55179)

Analyte: Carbon Dioxide, Total (CO2) (1003)

Test System, Assay, Examination:

Beckman Synchron CX 5 Delta (07763)

Beckman Synchron CX 7 Delta (07764)

Bio-Chem Laboratory Systems ATAC 8000

(07658)

Boehringer Mannheim Hitachi 917 (07765)

Johnson & Johnson CDI Ektachem 250

(31019)

Johnson & Johnson CDI Ektachem 400

(31020)

Johnson & Johnson CDI Ektachem 500

(31021)

Johnson & Johnson CDI Ektachem 550 XRC

(31022)

Johnson & Johnson CDI Ektachem 700

(31023)

Johnson & Johnson CDI Ektachem 700

Analyzer C Series (31024)

Johnson & Johnson CDI Ektachem 700 XR

(31026)

Johnson & Johnson CDI Ektachem 750 XRC

(31027)

Johnson & Johnson CDI Ektachem 950 IRC

(31028)

Johnson & Johnson CDI Ektachem DT II

(31030)

Johnson & Johnson CDI Ektachem DTE

Module (31033)

Roche Cobas INTEGRA (55179)

Analyte: Cerebrospinal Fluid (CSF) Protein

(1014)

Test System, Assay, Examination:

Beckman Synchron CX 4 Delta (07762)

Beckman Synchron CX 5 Delta (07763)

Beckman Synchron CX 7 Delta (07764)

Boehringer Mannheim Hitachi 917 (07765)

Johnson & Johnson CDI Ektachem 250

(31019)

Johnson & Johnson CDI Ektachem 400

(31020)

Johnson & Johnson CDI Ektachem 500

(31021)

Johnson & Johnson CDI Ektachem 550 XRC

(31022)

Johnson & Johnson CDI Ektachem 700

(31023)

Johnson & Johnson CDI Ektachem 700

Analyzer C Series (31024)

Johnson & Johnson CDI Ektachem 700 XR

(31026)

Johnson & Johnson CDI Ektachem 750 XRC

(31027)

Johnson & Johnson CDI Ektachem 950 IRC

(31028)

Analyte: Chloride (1018)

Test System, Assay, Examination:

AVL OMNI Combi Analyzer (04609)

Beckman Synchron CX 5 Delta (07763)

Beckman Synchron CX 7 Delta (07764)

Bio-Chem Laboratory Systems ATAC 8000

(07658)

Boehringer Mannheim Hitachi 917 (07765)

Johnson & Johnson CDI Ektachem 250

(31019)

Johnson & Johnson CDI Ektachem 400

(31020)

Johnson & Johnson CDI Ektachem 500

(31021)

Johnson & Johnson CDI Ektachem 550 XRC

(31022)

Johnson & Johnson CDI Ektachem 700

(31023)

Johnson & Johnson CDI Ektachem 700

Analyzer C Series (31024)

Johnson & Johnson CDI Ektachem 700 XR

(31026)

Johnson & Johnson CDI Ektachem 750 XRC

(31027)

Johnson & Johnson CDI Ektachem 950 IRC

(31028)

Johnson & Johnson CDI Ektachem DT II

(31030)

Johnson & Johnson CDI Ektachem DTE

Module (31033)

Medica EasyStat Na/K/Cl (40249)

Nova Stat Profile Ultra F (43115)

Nova Stat Profile Ultra G (43116)

Nova Stat Profile Ultra H (43117)

Radiometer ABL System 605 (55196)

Radiometer ABL System 615 (55197)

Radiometer ABL System 625 (55198)

Radiometer EML 105 (55187)

Roche Cobas INTEGRA (55179)

Select Medical Systems Selecta 20/60

(58349)

Analyte: Cholesterol (1020)

Test System, Assay, Examination:

Abaxis Piccolo Portable Blood Analyzer

(04608)

Actimed Laboratories ENA.C.T Total

Cholesterol Test (04573)

Beckman Synchron CX 4 Delta (07762)

Beckman Synchron CX 5 Delta (07763)

Beckman Synchron CX 7 Delta (07764)

Bio-Chem Laboratory Systems ATAC 8000

(07658)

Boehringer Mannheim Accutrend GC

Cholesterol Test (07600)

Boehringer Mannheim Hitachi 917 (07765)

Johnson & Johnson CDI Ektachem 250

(31019)

Johnson & Johnson CDI Ektachem 400

(31020)

Johnson & Johnson CDI Ektachem 500

(31021)

Johnson & Johnson CDI Ektachem 550 XRC

(31022)

Johnson & Johnson CDI Ektachem 700

(31023)

Johnson & Johnson CDI Ektachem 700

Analyzer C Series (31024)

Johnson & Johnson CDI Ektachem 700 P

(31025)

Johnson & Johnson CDI Ektachem 700 XR

(31026)

Johnson & Johnson CDI Ektachem 750 XRC

(31027)

Johnson & Johnson CDI Ektachem 950 IRC

(31028)

Johnson & Johnson CDI Ektachem DT 60

(31029)

Johnson & Johnson CDI Ektachem DT II

(31030)

Roche Cobas INTEGRA (55179)

Select Medical Systems Selecta 20/60

(58349)

Analyte: Cholinesterase (1021)

Test System, Assay, Examination:

Beckman Synchron CX 4 Delta (07762)

Beckman Synchron CX 5 Delta (07763)

Beckman Synchron CX 7 Delta (07764)

Boehringer Mannheim Hitachi 917 (07765)

Instrumentation Laboratory ILAB 1800

(28323)

Instrumentation Laboratory ILAB 900

(28322)

Johnson & Johnson CDI Ektachem 250

(31019)

Johnson & Johnson CDI Ektachem 500

(31021)

Johnson & Johnson CDI Ektachem 550 XRC

(31022)

Johnson & Johnson CDI Ektachem 700

(31023)

Johnson & Johnson CDI Ektachem 700

Analyzer C Series (31024)

Johnson & Johnson CDI Ektachem 700 XR

(31026)

Johnson & Johnson CDI Ektachem 750 XRC

(31027)

Johnson & Johnson CDI Ektachem 950 IRC

(31028)

Johnson & Johnson CDI Ektachem DT II

(31030)

Johnson & Johnson CDI Ektachem DT SC

Module (31031)

Roche Cobas INTEGRA (55179)

Analyte: Creatine Kinase (CK) (1034)

Test System, Assay, Examination:

Beckman Synchron CX 4 Delta (07762)

Beckman Synchron CX 5 Delta (07763)

Beckman Synchron CX 7 Delta (07764)

Bio-Chem Laboratory Systems ATAC 8000

(07658)

Boehringer Mannheim Hitachi 917 (07765)

Johnson & Johnson CDI Ektachem 250

(31019)

Johnson & Johnson CDI Ektachem 500

(31021)

Johnson & Johnson CDI Ektachem 550 XRC

(31022)

Johnson & Johnson CDI Ektachem 700

(31023)

Johnson & Johnson CDI Ektachem 700

Analyzer C Series (31024)

Johnson & Johnson CDI Ektachem 700 P

(31025)

Johnson & Johnson CDI Ektachem 700 XR

(31026)

Johnson & Johnson CDI Ektachem 750 XRC

(31027)

Johnson & Johnson CDI Ektachem 950 IRC

(31028)

Johnson & Johnson CDI Ektachem DT II

(31030)

Johnson & Johnson CDI Ektachem DT SC

Module (31031)

PrismaSystems PROCHEM (49105)

Roche Cobas INTEGRA (55179)

Select Medical Systems Selecta 20/60

(58349)

Analyte: Creatine Kinase MB Fraction

(CKMB) (1002)

Test System, Assay, Examination:

Beckman Synchron CX 4 Delta (07762)
Federal Register / Vol. 61, No. 131 / Monday, July 8, 1996 / Notices 35743

Beckman Synchron CX 5 Delta (07763)

Beckman Synchron CX 7 Delta (07764)

Bio-Chem Laboratory Systems ATAC 8000

(07658)

Boehringer Mannheim Hitachi 917 (07765)

Instrumentation Laboratory ILAB 1800

(28323)

Instrumentation Laboratory ILAB 900

(28322)

Johnson & Johnson CDI Ektachem 250

(31019)

Johnson & Johnson CDI Ektachem 500

(31021)

Johnson & Johnson CDI Ektachem 550 XRC

(31022)

Johnson & Johnson CDI Ektachem 700

(31023)

Johnson & Johnson CDI Ektachem 700

Analyzer C Series (31024)

Johnson & Johnson CDI Ektachem 700 P

(31025)

Johnson & Johnson CDI Ektachem 700 XR

(31026)

Johnson & Johnson CDI Ektachem 750 XRC

(31027)

Johnson & Johnson CDI Ektachem 950 IRC

(31028)

Johnson & Johnson CDI Ektachem DT II

(31030)

Johnson & Johnson CDI Ektachem DT SC

Module (31031)

Organon Teknika AuraFlex (46152)

Princeton BioMeditech Cardiac STATus

CK-MB/Myoglobin (49156)

Roche Cobas INTEGRA (55179)

Technicon Immuno 1 System (61042)

Analyte: Creatinine (1035)

Test System, Assay, Examination:

Abaxis Piccolo Portable Blood Analyzer

(04608)

Beckman Synchron CX 4 Delta (07762)

Beckman Synchron CX 5 Delta (07763)

Beckman Synchron CX 7 Delta (07764)

Bio-Chem Laboratory Systems ATAC 8000

(07658)

Boehringer Mannheim Hitachi 917 (07765)

Johnson & Johnson CDI Ektachem 250

(31019)

Johnson & Johnson CDI Ektachem 400

(31020)

Johnson & Johnson CDI Ektachem 500

(31021)

Johnson & Johnson CDI Ektachem 550 XRC

(31022)

Johnson & Johnson CDI Ektachem 700

(31023)

Johnson & Johnson CDI Ektachem 700

Analyzer C Series (31024)

Johnson & Johnson CDI Ektachem 700 P

(31025)

Johnson & Johnson CDI Ektachem 700 XR

(31026)

Johnson & Johnson CDI Ektachem 750 XRC

(31027)

Johnson & Johnson CDI Ektachem 950 IRC

(31028)

Johnson & Johnson CDI Ektachem DT 60

(31029)

Johnson & Johnson CDI Ektachem DT II

(31030)

Johnson & Johnson CDI Ektachem DT SC

Module (31031)

Roche Cobas INTEGRA (55179)

Select Medical Systems Selecta 20/60

(58349)

Analyte: Deoxyhemoglobin (Reduced

Hemoglobin) (1318)

Test System, Assay, Examination:

AVL OMNI Combi Analyzer (04609)

Instrumentation Laboratory IL682 COOximeter System (28368)

Nova Co-Oximeter (43114)

Radiometer ABL 520 (55055)

Radiometer ABL 620 (55137)

Radiometer ABL System 625 (55198)

Analyte: Ferritin (1902)

Test System, Assay, Examination:

Behring Nephelometer (07273)

Behring Nephelometer 100 (07272)

Behring Nephelometer II (07563)

Bio-Chem Laboratory Systems ATAC 8000

(07658)

Schiapparelli Biosystems ACE (58288)

Analyte: Folate (Folic acid) (1907)

Test System, Assay, Examination:

Abbott IMX (04056)

Schiapparelli Biosystems ACE (58288)

Technicon Immuno 1 System (61042)

Analyte: Folate, Red Blood Cell (RBC Folate)

(1930)

Test System, Assay, Examination:

Technicon Immuno 1 (with UIW) (61229)

Analyte: Fructosamine (1914)

Test System, Assay, Examination:

Bio-Chem Laboratory Systems ATAC 6000

(07189)

Boehringer Mannheim Hitachi 917 (07765)

LXN Fructosamine Test System (37106)

Roche Cobas INTEGRA (55179)

Analyte: Gamma Glutamyl Transferase

(GGT) (2201)

Test System, Assay, Examination:

Beckman Synchron CX 4 Delta (07762)

Beckman Synchron CX 5 Delta (07763)

Beckman Synchron CX 7 Delta (07764)

Bio-Chem Laboratory Systems ATAC 8000

(07658)

Boehringer Mannheim Hitachi 917 (07765)

Johnson & Johnson CDI Ektachem 250

(31019)

Johnson & Johnson CDI Ektachem 500

(31021)

Johnson & Johnson CDI Ektachem 550 XRC

(31022)

Johnson & Johnson CDI Ektachem 700

(31023)

Johnson & Johnson CDI Ektachem 700

Analyzer C Series (31024)

Johnson & Johnson CDI Ektachem 700 P

(31025)

Johnson & Johnson CDI Ektachem 700 XR

(31026)

Johnson & Johnson CDI Ektachem 750 XRC

(31027)

Johnson & Johnson CDI Ektachem 950 IRC

(31028)

Johnson & Johnson CDI Ektachem DT II

(31030)

Johnson & Johnson CDI Ektachem DT SC

Module (31031)

Roche Cobas INTEGRA (55179)

Select Medical Systems Selecta 20/60

(58349)

Analyte: Glucose (2203)

Test System, Assay, Examination:

Abaxis Piccolo Portable Blood Analyzer

(04608)

Beckman Synchron CX 4 Delta (07762)

Beckman Synchron CX 5 Delta (07763)

Beckman Synchron CX 7 Delta (07764)

Bio-Chem Laboratory Systems ATAC 8000

(07658)

Boehringer Mannheim Hitachi 917 (07765)

Instrumentation Laboratory IL BGGE (IL

1660) (28438)

Johnson & Johnson CDI Ektachem 250

(31019)

Johnson & Johnson CDI Ektachem 400

(31020)

Johnson & Johnson CDI Ektachem 500

(31021)

Johnson & Johnson CDI Ektachem 550 XRC

(31022)

Johnson & Johnson CDI Ektachem 700

(31023)

Johnson & Johnson CDI Ektachem 700

Analyzer C Series (31024)

Johnson & Johnson CDI Ektachem 700 P

(31025)

Johnson & Johnson CDI Ektachem 700 XR

(31026)

Johnson & Johnson CDI Ektachem 750 XRC

(31027)

Johnson & Johnson CDI Ektachem 950 IRC

(31028)

Johnson & Johnson CDI Ektachem DT 60

(31029)

Johnson & Johnson CDI Ektachem DT II

(31030)

Nova Stat Profile Ultra B (43109)

Nova Stat Profile Ultra C (43110)

Nova Stat Profile Ultra G (43116)

Nova Stat Profile Ultra H (43117)

Nova Stat Profile Ultra J (43119)

Nova Stat Profile Ultra K (43120)

Radiometer ABL System 605 (55196)

Radiometer ABL System 615 (55197)

Radiometer ABL System 625 (55198)

Radiometer EML 105 (55187)

Roche Cobas INTEGRA (55179)

Select Medical Systems Selecta 20/60

(58349)

Analyte: Glutaraldehyde (2224)

Test System, Assay, Examination:

Boehringer Mannheim Hitachi 717 (07163)

Analyte: Glycated Hemoglobin, Total (2221)

Test System, Assay, Examination:

Bio-Rad Variant (07498)

Helena Laboratories ColumnMate II

(25198)

Analyte: Glycosylated Hemoglobin (Hgb

A1C) (2204)

Test System, Assay, Examination:

Boehringer Mannheim Hitachi 917 (07765)

Analyte: HDL Cholesterol (2550)

Test System, Assay, Examination:

Abbott Spectrum (Canyon Cantrol tube)

(04610)

Abbott Spectrum (Ref Diag Magnetic HDL

Sep) (04595)

Abbott Spectrum (Sigma ISOSPIN) (04632)

Abbott Spectrum EPX (Ref Diag Magnetic

HDL Sep) (04596)

Abbott Spectrum EPX (Sigma ISOSPIN)

(04633)

Abbott TDX (Ref Diag Magnetic HDL Sep)

(04597)

Abbott VP (Sigma ISOSPIN) (04634)
35744 Federal Register / Vol. 61, No. 131 / Monday, July 8, 1996 / Notices

Baxter Paramax (Ref Diag Magnetic HDL

Sep) (07605)

Beckman CX (Canyon Cantrol tube) (07646)

Beckman Synchron CX 4 (Ref Diag

Magnetic HDL Sep) (07606)

Beckman Synchron CX 4 (Sigma ISOSPIN)

(07698)

Beckman Synchron CX 4 CE (Sigma

ISOSPIN) (07699)

Beckman Synchron CX 5 (Ref Diag

Magnetic HDL Sep) (07607)

Beckman Synchron CX 5 (Sigma ISOSPIN)

(07700)

Beckman Synchron CX 5 CE (Ref Diag

Magnetic HDL Sep) (07609)

Beckman Synchron CX 5 CE (Sigma

ISOSPIN) (07701)

Beckman Synchron CX 7 (Ref Diag

Magnetic HDL Sep) (07608)

Bio-Chem Laboratory Systems ATAC 6000

(Sigma ISOSPIN) (07702)

Bio-Chem Laboratory Systems ATAC 8000

(07658)

Boehringer Mannheim Hitachi (Canyon

Cantrol tube) (07647)

Boehringer Mannheim Hitachi 704 (Ref

Diag Magnetic HDL Sep) (07610)

Boehringer Mannheim Hitachi 704 (Sigma

ISOSPIN) (07703)

Boehringer Mannheim Hitachi 705 (Ref

Diag Magnetic HDL Sep) (07611)

Boehringer Mannheim Hitachi 705 (Sigma

ISOSPIN) (07704)

Boehringer Mannheim Hitachi 717 (Ref

Diag Magnetic HDL Sep) (07612)

Boehringer Mannheim Hitachi 717 (Sigma

ISOSPIN) (07705)

Boehringer Mannheim Hitachi 736 (Ref

Diag Magnetic HDL Sep) (07613)

Boehringer Mannheim Hitachi 736 (Sigma

ISOSPIN) (07706)

Boehringer Mannheim Hitachi 737 (Ref

Diag Magnetic HDL Sep) (07614)

Boehringer Mannheim Hitachi 737 (Sigma

ISOSPIN) (07707)

Boehringer Mannheim Hitachi 747 (Ref

Diag Magnetic HDL Sep) (07615)

Boehringer Mannheim Hitachi 747 (Sigma

ISOSPIN) (07708)

Boehringer Mannheim Hitachi 911 (Ref

Diag Magnetic HDL Sep) (07616)

Boehringer Mannheim Hitachi 911 (Sigma

ISOSPIN) (07709)

Boehringer Mannheim Hitachi 914 (Ref

Diag Magnetic HDL Sep) (07617)

ChemTrak AccuMeter HDL Cholesterol

Test (10311)

Ciba Corning 550 Express (Ref Diag

Magnetic HDL Sep) (10288)

Ciba Corning 550 Express (Sigma ISOSPIN)

(10322)

Ciba Corning 570 Alliance (Sigma

ISOSPIN) (10323)

Coulter Dacos (Ref Diag Magnetic HDL

Sep) (10289)

Coulter Dacos (Sigma ISOSPIN) (10324)

Du Pont ACA (Ref Diag Magnetic HDL Sep)

(13360)

Du Pont Dimension (Ref Diag Magnetic

HDL Sep) (13361)

EM Diagnostic Systems EPOS (Sigma

ISOSPIN) (16113)

Electronucleonics Gem-Profiler (Sigma

ISOSPIN) (16114)

Electronucleonics Gemini (Sigma ISOSPIN)

(16115)

Electronucleonics Gemstar (Sigma

ISOSPIN) (16116)

Electronucleonics Gemstar II (Sigma

ISOSPIN) (16117)

Instrumentation Lab. ILAB 900 (Ref Diag

Magnetic HDL Sep) (28378)

Instrumentation Lab.IL Monarch 1000 (Ref

Diag Magn HDL Sep) (28375)

Instrumentation Lab.IL Monarch 2000 (Ref

Diag Magn HDL Sep) (28376)

Instrumentation Lab.IL Monarch Plus (Ref

Diag Magn HDL Sep) (28377)

Instrumentation Laboratory IL Monarch

1000 (Sigma ISOSPIN) (28414)

Instrumentation Laboratory IL Monarch

2000 (Sigma ISOSPIN) (28415)

Instrumentation Laboratory IL Monarch

Plus (Sigma ISOSPIN) (28416)

Instrumentation Laboratory ILAB 1800

(Sigma ISOSPIN) (28421)

Instrumentation Laboratory ILAB 900

(Sigma ISOSPIN) (28420)

Johnson & Johnson CDI Ektachem (Canyon

Cantrol tube) (31034)

Johnson & Johnson CDI Ektachem 250

(31019)

Johnson & Johnson CDI Ektachem 250

(DMA One Shots) (31035)

Johnson & Johnson CDI Ektachem 250

(MHS SPINPRO) (31037)

Johnson & Johnson CDI Ektachem 250 (Ref

Diag Magn HDL Sep) (31038)

Johnson & Johnson CDI Ektachem 400

(31020)

Johnson & Johnson CDI Ektachem 400

(DMA One Shots) (31039)

Johnson & Johnson CDI Ektachem 400

(MHS SPINPRO) (31040)

Johnson & Johnson CDI Ektachem 400 (Ref

Diag Magn HDL Sep) (31041)

Johnson & Johnson CDI Ektachem 500

(31021)

Johnson & Johnson CDI Ektachem 500

(DMA One Shots) (31042)

Johnson & Johnson CDI Ektachem 500

(MHS SPINPRO) (31044)

Johnson & Johnson CDI Ektachem 500 (Ref

Diag Magn HDL Sep) (31045)

Johnson & Johnson CDI Ektachem 550 XRC

(31022)

Johnson & Johnson CDI Ektachem 550 XRC

Anal (DMA One Shots) (31046)

Johnson & Johnson CDI Ektachem 700

(31023)

Johnson & Johnson CDI Ektachem 700

(DMA One Shots) (31047)

Johnson & Johnson CDI Ektachem 700

(MHS SPINPRO) (31049)

Johnson & Johnson CDI Ektachem 700 (Ref

Diag Magn HDL Sep) (31050)

Johnson & Johnson CDI Ektachem 700

Analyzer C Series (31024)

Johnson & Johnson CDI Ektachem 700 C

Series (DMA One Shots) (31051)

Johnson & Johnson CDI Ektachem 700 P

(31025)

Johnson & Johnson CDI Ektachem 700 P

(DMA One Shots) (31052)

Johnson & Johnson CDI Ektachem 700 P

(MHS SPINPRO) (31053)

Johnson & Johnson CDI Ektachem 700 XR

(31026)

Johnson & Johnson CDI Ektachem 700 XR

(DMA One Shots) (31054)

Johnson & Johnson CDI Ektachem 700 XR

(MHS SPINPRO) (31055)

Johnson & Johnson CDI Ektachem 750 XRC

(31027)

Johnson & Johnson CDI Ektachem 750 XRC

(DMA One Shots) (31056)

Johnson & Johnson CDI Ektachem 950 IRC

(31028)

Johnson & Johnson CDI Ektachem DT 60

(31029)

Johnson & Johnson CDI Ektachem DT 60

(DMA One Shots) (31057)

Johnson & Johnson CDI Ektachem DT 60

(MHS SPINPRO) (31059)

Johnson & Johnson CDI Ektachem DT 60

(Ref Diag Magn HDL Sep) (31060)

Johnson & Johnson CDI Ektachem DT II

(31030)

Johnson & Johnson CDI Ektachem DT II

(DMA One Shots) (31061)

Johnson & Johnson CDI Ektachem DT II

(Ref Diag Magn HDL Sep) (31062)

Kodak Ektachem (Canyon Cantrol tube)

(34088)

Kodak Ektachem 250 (Ref Diag Magnetic

HDL Sep) (34072)

Kodak Ektachem 400 (Ref Diag Magnetic

HDL Sep) (34073)

Kodak Ektachem 500 (Ref Diag Magnetic

HDL Sep) (34074)

Kodak Ektachem 700 (Ref Diag Magnetic

HDL Sep) (34075)

Kodak Ektachem DT 60 (Ref Diag Magnetic

HDL Sep) (34070)

Kodak Ektachem DT II (Ref Diag Magnetic

HDL Sep) (34071)

LSI ASCA Chemistry System (Sigma

ISOSPIN) (37103)

Olympus AU 5000 (Ref Diag Magnetic HDL

Sep) (46171)

Olympus AU 5000 (Sigma ISOSPIN)

(46196)

Olympus AU 5021 (Sigma ISOSPIN)

(46197)

Olympus AU 5031 (Sigma ISOSPIN)

(46198)

Olympus AU 5041 (Sigma ISOSPIN)

(46199)

Olympus AU 5061 (Sigma ISOSPIN)

(46200)

Olympus AU 5121 (Sigma ISOSPIN)

(46201)

Olympus AU 5131 (Sigma ISOSPIN)

(46202)

Olympus AU 5200 (Ref Diag Magnetic HDL

Sep) (46172)

Olympus AU 5200 (Sigma ISOSPIN)

(46203)

Olympus AU 5211 (Sigma ISOSPIN)

(46204)

Olympus AU 5221 (Sigma ISOSPIN)

(46205)

Olympus AU 5223 (Sigma ISOSPIN)

(46206)

Olympus AU 5231 (Sigma ISOSPIN)

(46207)

Olympus AU 800 (Ref Diag Magnetic HDL

Sep) (46170)

Olympus AU 800 (Sigma ISOSPIN) (46208)

Olympus Demand (Ref Diag Magnetic HDL

Sep) (46169)

Olympus Demand (Sigma ISOSPIN)

(46209)

Olympus Reply (Ref Diag Magnetic HDL

Sep) (46168)

Olympus Reply (Sigma ISOSPIN) (46210)

Olympus Reply/AU560 (Sigma ISOSPIN)

(46211)
Federal Register / Vol. 61, No. 131 / Monday, July 8, 1996 / Notices 35745

Prisma Systems PROCHEM (Ref Diag

Magnetic HDL Sep) (49128)

Roche Cobas (Canyon Cantrol tube) (55160)

Roche Cobas Bio (Ref Diag Magnetic HDL

Sep) (55148)

Roche Cobas Bio (Sigma ISOSPIN) (55180)

Roche Cobas FARA (Ref Diag Magnetic

HDL Sep) (55150)

Roche Cobas FARA (Sigma ISOSPIN)

(55181)

Roche Cobas FARA II (Sigma ISOSPIN)

(55182)

Roche Cobas INTEGRA (55179)

Roche Cobas Mira (Ref Diag Magnetic HDL

Sep) (55149)

Roche Cobas Mira (Sigma ISOSPIN)

(55183)

Roche Cobas Mira Plus (Sigma ISOSPIN)

(55184)

Roche Cobas Mira S (Sigma ISOSPIN)

(55185)

Schiapparelli Biosystems ACE (Ref Diag

Magnetic HDL Sep) (58354)

Technicon AXON (Ref Diag Magnetic HDL

Sep) (61170)

Technicon AXON (Sigma ISOSPIN)

(61214)

Technicon Assist (Sigma ISOSPIN) (61213)

Technicon Chem 1 (Ref Diag Magnetic HDL

Sep) (61175)

Technicon DAX 24 (Ref Diag Magnetic

HDL Sep) (61171)

Technicon DAX 48 (Ref Diag Magnetic

HDL Sep) (61172)

Technicon DAX 72 (Ref Diag Magnetic

HDL Sep) (61173)

Technicon DAX 96 (Ref Diag Magnetic

HDL Sep) (61174)

Technicon RA 1000 (Ref Diag Magnetic

HDL Sep) (61177)

Technicon RA 1000 (Sigma ISOSPIN)

(61215)

Technicon RA 2000 (Ref Diag Magnetic

HDL Sep) (61178)

Technicon RA 500 (Ref Diag Magnetic HDL

Sep) (61176)

Technicon RA 500 (Sigma ISOSPIN)

(61216)

Technicon RA XT (Ref Diag Magnetic HDL

Sep) (61179)

Technicon RA XT (Sigma ISOSPIN)

(61217)

Wako Diagnostics 30R (Ref Diag Magnetic

HDL Sep) (70170)

Wako Diagnostics 30R (Sigma ISOSPIN)

(70176)

Analyte: Haptoglobin (2511)

Test System, Assay, Examination:

Roche Cobas INTEGRA (55179)

Analyte: Hemoglobin F (2516)

Test System, Assay, Examination:

Radiometer ABL 520 (55055)

Radiometer ABL 620 (55137)

Radiometer ABL System 625 (55198)

Analyte: Hemoglobin Fractions (2544)

Test System, Assay, Examination:

Bio-Rad Variant (07498)

Primus Variant System 99 (49159)

Analyte: Iron (2814)

Test System, Assay, Examination:

Beckman Synchron CX 4 Delta (07762)

Beckman Synchron CX 5 Delta (07763)

Beckman Synchron CX 7 Delta (07764)

Bio-Chem Laboratory Systems ATAC 8000

(07658)

Boehringer Mannheim Hitachi 917 (07765)

Johnson & Johnson CDI Ektachem 250

(31019)

Johnson & Johnson CDI Ektachem 400

(31020)

Johnson & Johnson CDI Ektachem 500

(31021)

Johnson & Johnson CDI Ektachem 550 XRC

(31022)

Johnson & Johnson CDI Ektachem 700

(31023)

Johnson & Johnson CDI Ektachem 700

Analyzer C Series (31024)

Johnson & Johnson CDI Ektachem 700 XR

(31026)

Johnson & Johnson CDI Ektachem 750 XRC

(31027)

Johnson & Johnson CDI Ektachem 950 IRC

(31028)

Johnson & Johnson CDI Ektachem DT SC

Module (31031)

Roche Cobas INTEGRA (55179)

Analyte: Iron Binding Capacity, Unsat.

(UIBC) No Pretreat. (2823)

Test System, Assay, Examination:

Boehringer Mannheim Hitachi 917 (07765)

Olympus AU 5000 (46001)

Olympus AU 5200 (46143)

Olympus AU 800 (46110)

Roche Cobas INTEGRA (55179)

Roche Cobas Mira (55044)

Roche Cobas Mira Plus (55096)

Roche Cobas Mira S (55045)

Analyte: LDL Cholesterol (3748)

Test System, Assay, Examination:

Abbott Spectrum (Genzyme immunosep

tube) (04612)

Abbott Spectrum EPX (Genzyme

immunosep tube) (04611)

Abbott Spectrum II (Genzyme immunosep

tube) (04613)

Abbott VP (Genzyme immunosep tube)

(04614)

Baxter Paramax (Genzyme immunosep

tube) (07657)

Beckman Synchron CX 4 (Genzyme

immunosep tube) (07659)

Beckman Synchron CX 5 (Genzyme

immunosep tube) (07660)

Bio-Chem Lab. Sys. ATAC 2000/2100

(Genzyme immunosep tube) (07656)

Bio-Chem Lab. Sys. ATAC 6000 (Genzyme

immunosep tube) (07655)

Boehringer Mannheim Hitachi 704

(Genzyme immunosep tube) (07648)

Boehringer Mannheim Hitachi 705

(Genzyme immunosep tube) (07649)

Boehringer Mannheim Hitachi 717

(Genzyme immunosep tube) (07650)

Boehringer Mannheim Hitachi 736

(Genzyme immunosep tube) (07651)

Boehringer Mannheim Hitachi 737

(Genzyme immunosep tube) (07652)

Boehringer Mannheim Hitachi 747

(Genzyme immunosep tube) (07653)

Boehringer Mannheim Hitachi 911

(Genzyme immunosep tube) (07654)

Ciba Corning 550 Express (Genzyme

immunosep tube) (10302)

Coulter Dacos (Genzyme immunosep tube)

(10301)

Coulter Optichem 120 (Genzyme

immunosep tube) (10303)

DuPont Dimension (Genzyme immunosep

tube/Dedicated channel) (13377)

DuPont Dimension AR (Genzyme

immunosep tube/Dedicated chan)

(13378)

EM Diagnostic Systems EPOS (Genzyme

immunosep tube) (16101)

Electronucleonics Gem-Profiler (Genzyme

immunosep tube) (16102)

Electronucleonics GemStar (Genzyme

immunosep tube) (16103)

Electronucleonics GemStar II (Genzyme

immunosep tube) (16104)

Instrumentation Lab.IL Monarch

1000(Genzyme immunosep tube) (28391)

Instrumentation Lab.IL Monarch

2000(Genzyme immunosep tube) (28393)

Instrumentation Lab.IL Monarch

Plus(Genzyme immunosep tube) (28392)

Johnson & Johnson CDI Ektachem DT II

(31030)

Kodak Ektachem DT II (34057)

LSI ASCA Chemistry System (Genzyme

Immunosep tube) (37099)

Olympus AU 5000 (Genzyme immunosep

tube) (46189)

Olympus AU 800 (Genzyme immunosep

tube) (46190)

Olympus Demand (Genzyme immunosep

tube) (46191)

Olympus Reply (Genzyme immunosep

tube) (46192)

Roche Cobas Bio (Genzyme immunosep

tube) (55161)

Roche Cobas FARA (Genzyme immunosep

tube) (55162)

Roche Cobas FARA II (Genzyme

immunosep tube) (55163)

Roche Cobas Mira (Genzyme immunosep

tube) (55164)

Schiapparelli Biosystems ACE (Genzyme

immunosep tube) (58366)

Technicon AXON (Genzyme immunosep

tube) (61193)

Technicon Assist (Genzyme immunosep

tube) (61188)

Technicon Chem 1 (Genzyme immunosep

tube/Dedicated channel) (61189)

Technicon RA 1000 (Genzyme immunosep

tube) (61191)

Technicon RA 500 (Genzyme immunosep

tube) (61190)

Technicon RA XT (Genzyme immunosep

tube) (61192)

Analyte: Lactate Dehydrogenase (LDH)

(3701)

Test System, Assay, Examination:

Beckman Synchron CX 4 Delta (07762)

Beckman Synchron CX 5 Delta (07763)

Beckman Synchron CX 7 Delta (07764)

Bio-Chem Laboratory Systems ATAC 8000

(07658)

Boehringer Mannheim Hitachi 917 (07765)

Johnson & Johnson CDI Ektachem 250

(31019)

Johnson & Johnson CDI Ektachem 400

(31020)

Johnson & Johnson CDI Ektachem 500

(31021)

Johnson & Johnson CDI Ektachem 550 XRC

(31022)

Johnson & Johnson CDI Ektachem 700

(31023)

Johnson & Johnson CDI Ektachem 700

Analyzer C Series (31024)
35746 Federal Register / Vol. 61, No. 131 / Monday, July 8, 1996 / Notices

Johnson & Johnson CDI Ektachem 700 P

(31025)

Johnson & Johnson CDI Ektachem 700 XR

(31026)

Johnson & Johnson CDI Ektachem 750 XRC

(31027)

Johnson & Johnson CDI Ektachem 950 IRC

(31028)

Johnson & Johnson CDI Ektachem DT II

(31030)

Johnson & Johnson CDI Ektachem DT SC

Module (31031)

Roche Cobas INTEGRA (55179)

Select Medical Systems Selecta 20/60

(58349)

Analyte: Lactate Dehydrogenase Heart

Fraction (LDH–1) (3702)

Test System, Assay, Examination:

Boehringer Mannheim Hitachi 917 (07765)

Roche Cobas INTEGRA (55179)

Analyte: Lactic Acid (Lactate) (3704)

Test System, Assay, Examination:

Beckman Synchron CX 4 Delta (07762)

Beckman Synchron CX 5 Delta (07763)

Beckman Synchron CX 7 Delta (07764)

Boehringer Mannheim Accusport Lactate

Monitoring System (07663)

Johnson & Johnson CDI Ektachem 250

(31019)

Johnson & Johnson CDI Ektachem 500

(31021)

Johnson & Johnson CDI Ektachem 550 XRC

(31022)

Johnson & Johnson CDI Ektachem 700

(31023)

Johnson & Johnson CDI Ektachem 700

Analyzer C Series (31024)

Johnson & Johnson CDI Ektachem 700 XR

(31026)

Johnson & Johnson CDI Ektachem 750 XRC

(31027)

Johnson & Johnson CDI Ektachem 950 IRC

(31028)

Johnson & Johnson CDI Ektachem DT 60

(31029)

Johnson & Johnson CDI Ektachem DT II

(31030)

Nova Stat Profile Ultra A (43108)

Nova Stat Profile Ultra C (43110)

Nova Stat Profile Ultra H (43117)

Nova Stat Profile Ultra K (43120)

Analyte: Leucine Aminopeptidase (LAP)

(3709)

Test System, Assay, Examination:

Beckman Synchron CX 4 Delta (07762)

Beckman Synchron CX 5 Delta (07763)

Beckman Synchron CX 7 Delta (07764)

Analyte: Lipase (3711)

Test System, Assay, Examination:

Beckman Synchron CX 4 CE (07174)

Beckman Synchron CX 4 Delta (07762)

Beckman Synchron CX 5 CE (07491)

Beckman Synchron CX 5 Delta (07763)

Beckman Synchron CX 7 (07073)

Beckman Synchron CX 7 Delta (07764)

Boehringer Mannheim Hitachi 917 (07765)

Instrumentation Laboratory ILAB 1800

(28323)

Instrumentation Laboratory ILAB 900

(28322)

Johnson & Johnson CDI Ektachem 250

(31019)

Johnson & Johnson CDI Ektachem 400

(31020)

Johnson & Johnson CDI Ektachem 500

(31021)

Johnson & Johnson CDI Ektachem 550 XRC

(31022)

Johnson & Johnson CDI Ektachem 700

(31023)

Johnson & Johnson CDI Ektachem 700

Analyzer C Series (31024)

Johnson & Johnson CDI Ektachem 700 P

(31025)

Johnson & Johnson CDI Ektachem 700 XR

(31026)

Johnson & Johnson CDI Ektachem 750 XRC

(31027)

Johnson & Johnson CDI Ektachem 950 IRC

(31028)

Johnson & Johnson CDI Ektachem DT 60

(31029)

Johnson & Johnson CDI Ektachem DT II

(31030)

Roche Cobas INTEGRA (55179)

Analyte: Magnesium (4002)

Test System, Assay, Examination:

Beckman Synchron CX 4 Delta (07762)

Beckman Synchron CX 5 Delta (07763)

Beckman Synchron CX 7 Delta (07764)

Bio-Chem Laboratory Systems ATAC 8000

(07658)

Boehringer Mannheim Hitachi 917 (07765)

Johnson & Johnson CDI Ektachem 250

(31019)

Johnson & Johnson CDI Ektachem 400

(31020)

Johnson & Johnson CDI Ektachem 500

(31021)

Johnson & Johnson CDI Ektachem 550 XRC

(31022)

Johnson & Johnson CDI Ektachem 700

(31023)

Johnson & Johnson CDI Ektachem 700

Analyzer C Series (31024)

Johnson & Johnson CDI Ektachem 700 P

(31025)

Johnson & Johnson CDI Ektachem 700 XR

(31026)

Johnson & Johnson CDI Ektachem 750 XRC

(31027)

Johnson & Johnson CDI Ektachem 950 IRC

(31028)

Johnson & Johnson CDI Ektachem DT 60

(31029)

Johnson & Johnson CDI Ektachem DT II

(31030)

Roche Cobas INTEGRA (55179)

Select Medical Systems Selecta 20/60

(58349)

Analyte: Magnesium, Ionized (4018)

Test System, Assay, Examination:

Nova Stat Profile Ultra C (43110)

Analyte: Methemoglobin (4032)

Test System, Assay, Examination:

AVL OMNI Combi Analyzer (04609)

Instrumentation Laboratory IL682 COOximeter System (28368)

Nova Co-Oximeter (43114)

Radiometer ABL 520 (55055)

Radiometer ABL 620 (55137)

Radiometer ABL System 625 (55198)

Radiometer OSM 3 (55059)

Analyte: Microprotein, CSF (4026)

Test System, Assay, Examination:

Beckman Synchron CX 4 Delta (07762)

Beckman Synchron CX 5 Delta (07763)

Beckman Synchron CX 7 Delta (07764)

Analyte: Microprotein, Urine (4027)

Test System, Assay, Examination:

Beckman Synchron CX 4 Delta (07762)

Beckman Synchron CX 5 Delta (07763)

Beckman Synchron CX 7 Delta (07764)

Analyte: Myoglobin (4023)

Test System, Assay, Examination:

Princeton BioMeditech Cardiac STATus

CK–MB/Myoglobin (49156)

Sanofi Pasteur Access Immunoassay

System (58257)

Analyte: Oxyhemoglobin/Oxygen Saturation

(4604)

Test System, Assay, Examination:

A–VOX Systems AVOXimeter 1000

(04537)

A–VOX Systems AVOXimeter 2000

(04538)

AVL OMNI Combi Analyzer (04609)

Instrumentation Laboratory IL682 COOximeter System (28368)

Nova Co-Oximeter (43114)

Nova Stat Profile Ultra A (43108)

Nova Stat Profile Ultra B (43109)

Nova Stat Profile Ultra C (43110)

Nova Stat Profile Ultra E (43112)

Nova Stat Profile Ultra F (43115)

Nova Stat Profile Ultra G (43116)

Nova Stat Profile Ultra H (43117)

Nova Stat Profile Ultra I (43118)

Nova Stat Profile Ultra J (43119)

Nova Stat Profile Ultra K (43120)

Radiometer ABL 510 (55054)

Radiometer ABL System 615 (55197)

Radiometer ABL System 625 (55198)

Analyte: Phosphorus (4906)

Test System, Assay, Examination:

Beckman Synchron CX 4 Delta (07762)

Beckman Synchron CX 5 Delta (07763)

Beckman Synchron CX 7 Delta (07764)

Bio-Chem Laboratory Systems ATAC 8000

(07658)

Boehringer Mannheim Hitachi 917 (07765)

Johnson & Johnson CDI Ektachem 250

(31019)

Johnson & Johnson CDI Ektachem 400

(31020)

Johnson & Johnson CDI Ektachem 500

(31021)

Johnson & Johnson CDI Ektachem 550 XRC

(31022)

Johnson & Johnson CDI Ektachem 700

(31023)

Johnson & Johnson CDI Ektachem 700

Analyzer C Series (31024)

Johnson & Johnson CDI Ektachem 700 P

(31025)

Johnson & Johnson CDI Ektachem 700 XR

(31026)

Johnson & Johnson CDI Ektachem 750 XRC

(31027)

Johnson & Johnson CDI Ektachem 950 IRC

(31028)

Johnson & Johnson CDI Ektachem DT 60

(31029)

Johnson & Johnson CDI Ektachem DT II

(31030)

Roche Cobas INTEGRA (55179)

Select Medical Systems Selecta 20/60

(58349)
Federal Register / Vol. 61, No. 131 / Monday, July 8, 1996 / Notices 35747

Analyte: Potassium (4910)

Test System, Assay, Examination:

AVL OMNI Combi Analyzer (04609)

Abaxis Piccolo Portable Blood Analyzer

(04608)

Beckman Synchron CX 5 Delta (07763)

Beckman Synchron CX 7 Delta (07764)

Bio-Chem Laboratory Systems ATAC 8000

(07658)

Boehringer Mannheim Hitachi 917 (07765)

Du Pont Na+K+Plus Analyzer (13394)

Instrumentation Laboratory IL BGGE (IL

1660) (28438)

Johnson & Johnson CDI Ektachem 250

(31019)

Johnson & Johnson CDI Ektachem 400

(31020)

Johnson & Johnson CDI Ektachem 500

(31021)

Johnson & Johnson CDI Ektachem 550 XRC

(31022)

Johnson & Johnson CDI Ektachem 700

(31023)

Johnson & Johnson CDI Ektachem 700

Analyzer C Series (31024)

Johnson & Johnson CDI Ektachem 700 XR

(31026)

Johnson & Johnson CDI Ektachem 750 XRC

(31027)

Johnson & Johnson CDI Ektachem 950 IRC

(31028)

Johnson & Johnson CDI Ektachem DT II

(31030)

Johnson & Johnson CDI Ektachem DTE

Module (31033)

Medica EasyStat Na/K (40248)

Medica EasyStat Na/K/Cl (40249)

Nova Stat Profile Ultra B (43109)

Nova Stat Profile Ultra C (43110)

Nova Stat Profile Ultra F (43115)

Nova Stat Profile Ultra G (43116)

Nova Stat Profile Ultra H (43117)

Nova Stat Profile Ultra I (43118)

Nova Stat Profile Ultra J (43119)

Nova Stat Profile Ultra K (43120)

Radiometer ABL System 605 (55196)

Radiometer ABL System 615 (55197)

Radiometer ABL System 625 (55198)

Radiometer EML 105 (55187)

Roche Cobas INTEGRA (55179)

SenDx 100 pH, Blood Gas and Electrolyte

Analysis System (58390)

Analyte: Protein, Total (4921)

Test System, Assay, Examination:

Abaxis Piccolo Portable Blood Analyzer

(04608)

Beckman Synchron CX 4 Delta (07762)

Beckman Synchron CX 5 Delta (07763)

Beckman Synchron CX 7 Delta (07764)

Bio-Chem Laboratory Systems ATAC 8000

(07658)

Boehringer Mannheim Hitachi 917 (07765)

Johnson & Johnson CDI Ektachem 250

(31019)

Johnson & Johnson CDI Ektachem 400

(31020)

Johnson & Johnson CDI Ektachem 500

(31021)

Johnson & Johnson CDI Ektachem 550 XRC

(31022)

Johnson & Johnson CDI Ektachem 700

(31023)

Johnson & Johnson CDI Ektachem 700

Analyzer C Series (31024)

Johnson & Johnson CDI Ektachem 700 P

(31025)

Johnson & Johnson CDI Ektachem 700 XR

(31026)

Johnson & Johnson CDI Ektachem 750 XRC

(31027)

Johnson & Johnson CDI Ektachem 950 IRC

(31028)

Johnson & Johnson CDI Ektachem DT 60

(31029)

Johnson & Johnson CDI Ektachem DT II

(31030)

Roche Cobas INTEGRA (55179)

Select Medical Systems Selecta 20/60

(58349)

Analyte: Protein, Total (urine) (4972)

Test System, Assay, Examination:

Boehringer Mannheim Hitachi 917 (07765)

Analyte: Reduced Hemoglobin

(Deoxyhemoglobin) (5523)

Test System, Assay, Examination:

Radiometer OSM 3 (55059)

Analyte: Sodium (5805)

Test System, Assay, Examination:

AVL OMNI Combi Analyzer (04609)

Beckman Synchron CX 5 Delta (07763)

Beckman Synchron CX 7 Delta (07764)

Bio-Chem Laboratory Systems ATAC 8000

(07658)

Boehringer Mannheim Hitachi 917 (07765)

Du Pont Na+K+Plus Analyzer (13394)

Instrumentation Laboratory IL BGGE (IL

1660) (28438)

Johnson & Johnson CDI Ektachem 250

(31019)

Johnson & Johnson CDI Ektachem 400

(31020)

Johnson & Johnson CDI Ektachem 500

(31021)

Johnson & Johnson CDI Ektachem 550 XRC

(31022)

Johnson & Johnson CDI Ektachem 700

(31023)

Johnson & Johnson CDI Ektachem 700

Analyzer C Series (31024)

Johnson & Johnson CDI Ektachem 700 XR

(31026)

Johnson & Johnson CDI Ektachem 750 XRC

(31027)

Johnson & Johnson CDI Ektachem 950 IRC

(31028)

Johnson & Johnson CDI Ektachem DT II

(31030)

Johnson & Johnson CDI Ektachem DTE

Module (31033)

Medica EasyStat Na/K (40248)

Medica EasyStat Na/K/Cl (40249)

Nova Stat Profile Ultra A (43108)

Nova Stat Profile Ultra B (43109)

Nova Stat Profile Ultra C (43110)

Nova Stat Profile Ultra E (43112)

Nova Stat Profile Ultra F (43115)

Nova Stat Profile Ultra G (43116)

Nova Stat Profile Ultra H (43117)

Nova Stat Profile Ultra I (43118)

Nova Stat Profile Ultra J (43119)

Nova Stat Profile Ultra K (43120)

Radiometer ABL System 605 (55196)

Radiometer ABL System 615 (55197)

Radiometer ABL System 625 (55198)

Radiometer EML 105 (55187)

Roche Cobas INTEGRA (55179)

SenDx 100 pH, Blood Gas and Electrolyte

Analysis System (58390)

Analyte: Sulfhemoglobin (5836)

Test System, Assay, Examination:

AVL OMNI Combi Analyzer (04609)

Analyte: Transferrin (6114)

Test System, Assay, Examination:

Beckman Synchron CX 4 Delta (07762)

Beckman Synchron CX 5 Delta (07763)

Beckman Synchron CX 7 Delta (07764)

Boehringer Mannheim Hitachi 917 (07765)

Roche Cobas INTEGRA (55179)

Analyte: Triglyceride (6118)

Test System, Assay, Examination:

Beckman Synchron CX 4 Delta (07762)

Beckman Synchron CX 5 Delta (07763)

Beckman Synchron CX 7 Delta (07764)

Bio-Chem Laboratory Systems ATAC 8000

(07658)

Boehringer Mannheim Hitachi 917 (07765)

Johnson & Johnson CDI Ektachem 250

(31019)

Johnson & Johnson CDI Ektachem 400

(31020)

Johnson & Johnson CDI Ektachem 500

(31021)

Johnson & Johnson CDI Ektachem 550 XRC

(31022)

Johnson & Johnson CDI Ektachem 700

(31023)

Johnson & Johnson CDI Ektachem 700

Analyzer C Series (31024)

Johnson & Johnson CDI Ektachem 700 P

(31025)

Johnson & Johnson CDI Ektachem 700 XR

(31026)

Johnson & Johnson CDI Ektachem 750 XRC

(31027)

Johnson & Johnson CDI Ektachem 950 IRC

(31028)

Johnson & Johnson CDI Ektachem DT 60

(31029)

Johnson & Johnson CDI Ektachem DT II

(31030)

Roche Cobas INTEGRA (55179)

Select Medical Systems Selecta 20/60

(58349)

Analyte: Troponin T, Cardiac (cTnT) (6154)

Test System, Assay, Examination:

Boehringer Mannheim CARDIAC T Rapid

Assay (07690)

Analyte: Urea (BUN) (6403)

Test System, Assay, Examination:

Abaxis Piccolo Portable Blood Analyzer

(04608)

Beckman Synchron CX 4 Delta (07762)

Beckman Synchron CX 5 Delta (07763)

Beckman Synchron CX 7 Delta (07764)

Bio-Chem Laboratory Systems ATAC 8000

(07658)

Boehringer Mannheim Hitachi 917 (07765)

Johnson & Johnson CDI Ektachem 250

(31019)

Johnson & Johnson CDI Ektachem 400

(31020)

Johnson & Johnson CDI Ektachem 500

(31021)

Johnson & Johnson CDI Ektachem 550 XRC

(31022)

Johnson & Johnson CDI Ektachem 700

(31023)

Johnson & Johnson CDI Ektachem 700

Analyzer C Series (31024)

Johnson & Johnson CDI Ektachem 700 P

(31025)
35748 Federal Register / Vol. 61, No. 131 / Monday, July 8, 1996 / Notices

Johnson & Johnson CDI Ektachem 700 XR

(31026)

Johnson & Johnson CDI Ektachem 750 XRC

(31027)

Johnson & Johnson CDI Ektachem 950 IRC

(31028)

Johnson & Johnson CDI Ektachem DT 60

(31029)

Johnson & Johnson CDI Ektachem DT II

(31030)

Nova Stat Profile Ultra F (43115)

Nova Stat Profile Ultra G (43116)

Nova Stat Profile Ultra H (43117)

Nova Stat Profile Ultra I (43118)

Nova Stat Profile Ultra J (43119)

Nova Stat Profile Ultra K (43120)

Roche Cobas INTEGRA (55179)

Select Medical Systems Selecta 20/60

(58349)

Analyte: Uric Acid (6404)

Test System, Assay, Examination:

Beckman Synchron CX 4 Delta (07762)

Beckman Synchron CX 5 Delta (07763)

Beckman Synchron CX 7 Delta (07764)

Bio-Chem Laboratory Systems ATAC 8000

(07658)

Boehringer Mannheim Hitachi 917 (07765)

Johnson & Johnson CDI Ektachem 250

(31019)

Johnson & Johnson CDI Ektachem 400

(31020)

Johnson & Johnson CDI Ektachem 500

(31021)

Johnson & Johnson CDI Ektachem 550 XRC

(31022)

Johnson & Johnson CDI Ektachem 700

(31023)

Johnson & Johnson CDI Ektachem 700

Analyzer C Series (31024)

Johnson & Johnson CDI Ektachem 700 P

(31025)

Johnson & Johnson CDI Ektachem 700 XR

(31026)

Johnson & Johnson CDI Ektachem 750 XRC

(31027)

Johnson & Johnson CDI Ektachem 950 IRC

(31028)

Johnson & Johnson CDI Ektachem DT 60

(31029)

Johnson & Johnson CDI Ektachem DT II

(31030)

Roche Cobas INTEGRA (55179)

Select Medical Systems Selecta 20/60

(58349)

Analyte: Vitamin B12 (6707)

Test System, Assay, Examination:

Boehringer Mannheim Hitachi 911 (07377)

PB Diagnostics Systems OPUS (49001)

BB Diagnostics Systems OPUS Magnum

(49097)

BB Diagnostics Systems OPUS PLUS

(49098)

Schiapparelli Biosystems ACE (58288)

Analyte: pH, Urine (4978)

Test System, Assay, Examination:

Boehringer Mannheim Hitachi 704 (DRI

pH-Detect) (07750)

Boehringer Mannheim Hitachi 717 (DRI

pH-Detect) (07751)

Boehringer Mannheim Hitachi 747 (DRI

pH-Detect) (07752)

Boehringer Mannheim Hitachi 747 (STC

Auto-Lyte) (07767)

Boehringer Mannheim Hitachi 911 (DRI

pH-Detect) (07753)

Olympus AU 5000 (DRI pH-Detect) (46216)

Speciality/Subspeciality: General

Immunology

Analyte: Allergen Specific IgE (0417)

Test System, Assay, Examination:

Quidel QuickVue One-Step Allergen

Screen (52028)

Analyte: Alpha-1-Acid Glycoprotein

(Orosomucoid) (0420)

Test System, Assay, Examination:

Roche Cobas INTEGRA (55179)

Analyte: Alpha-1-Antitrypsin (0421)

Test System, Assay, Examination:

Roche Cobas INTEGRA (55179)

Analyte: Anti-DNA Antibodies (0435)

Test System, Assay, Examination:

Hycor HY-TEC Anti-dsDNA (25251)

Analyte: Anti-DNP Antibodies (0436)

Test System, Assay, Examination:

Immunostics immuno/sle (screening)

(28424)

Immunostics immuno/sle (semiquantitative) (28425)

Analyte: Anti-ENA Antibodies (0507)

Test System, Assay, Examination:

Hycor HY-TEC ENA Screen(6)(SS-A,SSB,Sm,Sm/RNP,Scl-70,Jo-1) (25248)

Analyte: Anti-Jo-1 (0438)

Test System, Assay, Examination:

Hycor HY-TEC Anti-Jo-1 (25253)

Analyte: Anti-RNP-Sm Antibodies (0502)

Test System, Assay, Examination:

Hycor HY-TEC Anti-Sm/RNP (25255)

Analyte: Anti-SS-A/Ro (0446)

Test System, Assay, Examination:

Hycor HY-TEC Anti-SS-A (25247)

Analyte: Anti-SS-B/La (0447)

Test System, Assay, Examination:

Hycor HY-TEC Anti-SS-B (25249)

Analyte: Anti-Scl-70 (0448)

Test System, Assay, Examination:

Hycor HY-TEC Anti-Scl-70 (25252)

Analyte: Anti-Sm (Smith) (0450)

Test System, Assay, Examination:

Hycor HY-TEC Anti-Sm (25254)

Analyte: Anti-Streptolysin O (ASO) (0452)

Test System, Assay, Examination:

Beckman Synchron CX 4 Delta (07762)

Beckman Synchron CX 5 Delta (07763)

Beckman Synchron CX 7 Delta (07764)

Immunostics immuno/aSO (qualitative)

(28427)

Immunostics immuno/aSO (semiquantitative) (28426)

Olympus AU 800 (46110)

Olympus Reply (46089)

Roche Cobas INTEGRA (55179)

Analyte: Anti-Thyroglobulin Antibodies

(0453)

Test System, Assay, Examination:

Organon Teknika AuraFlex (46152)

Analyte: Beta-2 microglobulin (0703)

Test System, Assay, Examination:

Instrumentation Laboratory ILAB 1800

(28323)

Instrumentation Laboratory ILAB 900

(28322)

Organon Teknika AuraFlex (46152)

Analyte: Bladder Tumor Associated

Analytes (0737)

Test System, Assay, Examination:

Bard BTA Test Kit (07736)

Analyte: C-Reactive Protein (CRP) (1001)

Test System, Assay, Examination:

Beckman Synchron CX 4 Delta (07762)

Beckman Synchron CX 5 Delta (07763)

Beckman Synchron CX 7 Delta (07764)

Boehringer Mannheim Hitachi 917 (07765)

Johnson & Johnson CDI Ektachem 250

(31019)

Johnson & Johnson CDI Ektachem 950 IRC

(31028)

Randox Laboratories CRP Latex Test

(55202)

Roche Cobas INTEGRA (55179)

Analyte: CD4 Positive Lymphocytes (1116)

Test System, Assay, Examination:

Biometric Imaging IMAGN 2000 (absolute

count) (07599)

Biometric Imaging Volumet 1000 (absolute

count) (07735)

Analyte: CD8 Positive Lymphocytes (1118)

Test System, Assay, Examination:

Biometric Imaging IMAGN 2000 (absolute

count) (07599)

Biometric Imaging Volumet 1000 (absolute

count) (07735)

Analyte: Complement C3 (1029)

Test System, Assay, Examination:

Boehringer Mannheim Hitachi 917 (07765)

Roche Cobas INTEGRA (55179)

Analyte: Complement C4 (1030)

Test System, Assay, Examination:

Boehringer Mannheim Hitachi 917 (07765)

Roche Cobas INTEGRA (55179)

Analyte: Complement, Total (1046)

Test System, Assay, Examination:

Boehringer Mannheim Hitachi 704 (07161)

Boehringer Mannheim Hitachi 717 (07163)

Boehringer Mannheim Hitachi 747 (07166)

Boehringer Mannheim Hitachi 917 (07765)

Instrumentation Laboratory ILAB 1800

(28323)

Instrumentation Laboratory ILAB 900

(28322)

Olympus AU 800 (46110)

Olympus Reply/AU560 (46129)

Roche Cobas FARA II (55041)

Roche Cobas Mira (55044)

Wako Diagnostics 30R (70002)

Analyte: Febrile Agglutinins (1901)

Test System, Assay, Examination:

Immunostics immuno/febrile antigens

(rapid slide test) (28430)

Immunostics immuno/febrile antigens (test

tube titration) (28431)

SA Scientific SAS Febrile Antigen Set

(slide) (58391)

SA Scientific SAS Febrile Antigen Set

(tube) (58392)
Federal Register / Vol. 61, No. 131 / Monday, July 8, 1996 / Notices 35749

Analyte: Helicobacter Pylori Antibodies

(2513)

Test System, Assay, Examination:

Cortecs Ltd Helisal Rapid Blood Test

(10317)

Orion Diagnostica Pyloriset Dry (46157)

Quidel QuickVue One-Step H. pylori Test

(52027)

Washington Biotechnology PS II (70172)

Analyte: Hepatitis B Surface Antigen

(HBsAg) (2524)

Test System, Assay, Examination:

Abbott IMX (04056)

Analyte: Immunoglobulins IgA (2803)

Test System, Assay, Examination:

Beckman Synchron CX 4 Delta (07762)

Beckman Synchron CX 5 Delta (07763)

Beckman Synchron CX 7 Delta (07764)

Boehringer Mannheim Hitachi 917 (07765)

Olympus AU 800 (46110)

Roche Cobas INTEGRA (55179)

Analyte: Immunoglobulins IgE (2805)

Test System, Assay, Examination:

Pharmacia CAP System/AutoCap

Phadiatop FEIA (49158)

Analyte: Immunoglobulins IgG (2806)

Test System, Assay, Examination:

Beckman Synchron CX 4 Delta (07762)

Beckman Synchron CX 5 Delta (07763)

Beckman Synchron CX 7 Delta (07764)

Boehringer Mannheim Hitachi 917 (07765)

Olympus AU 800 (46110)

Roche Cobas INTEGRA (55179)

Analyte: Immunoglobulins IgM (2808)

Test System, Assay, Examination:

Beckman Synchron CX 4 Delta (07762)

Beckman Synchron CX 5 Delta (07763)

Beckman Synchron CX 7 Delta (07764)

Boehringer Mannheim Hitachi 917 (07765)

Olympus AU 800 (46110)

Roche Cobas INTEGRA (55179)

Analyte: Infectious Mononucleosis

Antibodies (Mono) (2809)

Test System, Assay, Examination:

Immunostics immuno/color-im Test

(28432)

Immunostics immuno/lex-im Test (28433)

Worldwide Medical First Check Mono

(70189)

Analyte: Lyme Disease Antibodies (Borrelia

Burgdorferi Abs) (3714)

Test System, Assay, Examination:

General Biometrics ImmunoDOT Borrelia

DotBlot G Test (22178)

General Biometrics ImmunoDOT Borrelia

DotBlot M Test (22177)

Vitek Systems VIDAS Lyme IgG and IgM

(LYT) (67097)

Analyte: Mycoplasma pneumoniae

Antibodies (4016)

Test System, Assay, Examination:

Shared Systems M. pneumoniae Rapid

Latex (qualitative) (58355)

Shared Systems M. pneumoniae Rapid

Latex (semi-quant.) (58356)

Analyte: Rheumatoid Factor (RF) (5508)

Test System, Assay, Examination:

Hycor HY–TEC Anti-RF (25250)

Immunostics immuno/ra (screening)

(28423)

Immunostics immuno/ra (semiquantitative) (28422)

Olympus AU 800 (46110)

Olympus Reply (46089)

Polymedco Rheumatoid Factors (RF) Latex

Agglutination (49157)

Shared Systems Chromalex Rheumatoid

Factor Latex Test Sys. (58382)

Analyte: Rubella Antibodies (5510)

Test System, Assay, Examination:

Abbott AxSYM Rubella IgM (04630)

Abbott IMX Rubella IgM (04638)

Sanofi Pasteur Access Immunoassay

System (58257)

Seradyn ColorSlide Rubella (58369)

Technicon Immuno 1 Rubella IgG (61227)

Worldwide Medical First Check Rubella

(70183)

Analyte: Thyroid Peroxidase Autoantibodies

(TPO) (6135)

Test System, Assay, Examination:

Organon Teknika AuraFlex (46152)

Analyte: Toxoplasma Gondii Antibodies

(6113)

Test System, Assay, Examination:

Abbott IMX Toxo IgG (04639)

Abbott IMX Toxo IgM (04593)

Cirrus Diagnostics Immulite (10159)

Sanofi Pasteur Access Immunoassay

System Toxo IgG (58376)

Analyte: Troponin-I (Cardiac) (6153)

Test System, Assay, Examination:

Baxter Stratus II (07051)

Baxter Stratus IIntellect (07376)

PB Diagnostics Systems OPUS (49001)

PB Diagnostics Systems OPUS Magnum

(49097)

PB Diagnostics Systems OPUS PLUS

(49098)

Speciality/Subspeciality: Hematology

Analyte: APTT Factor Substitution (0517)

Test System, Assay, Examination:

Medical Laboratory MLA Electra 1400C

(40208)

Analyte: Activated Partial Thromboplastin

Time (APTT) (0409)

Test System, Assay, Examination:

Bio/Data Microsample Coagulation

Analyzer, MCA 310 (07597)

Cardiovascular Diagnostics TAS Analyzer

HMT (10279)

Instrumentation Laboratory IL ACL Futura

System (28395)

Medical Laboratory MLA Electra 1400C

(40208)

Analyte: Coagulation Index, Native Whole

Blood (1130)

Test System, Assay, Examination:

Haemoscope Thromboelastograph 3000S

(TEG 3000S) (25257)

Analyte: Fibrinogen (1905)

Test System, Assay, Examination:

Bio/Data Microsample Coagulation

Analyzer, MCA 310 (07597)

Instrumentation Laboratory IL ACL Futura

System (28395)

Medical Laboratory MLA Electra 1400C

(40208)

Analyte: Hematocrit (2514)

Test System, Assay, Examination:

AVL OMNI Combi Analyzer (04609)

Becton Dickinson QBC AccuRead (07747)

BioChem Immunosystems Baker System

9100+ (07711)

BioChem Immunosystems Baker System

9110+ (07712)

BioChem Immunosystems Baker System

9118+ (07713)

BioChem Immunosystems Baker System

9120+ (07714)

Coulter MD II Series Analyzer (10318)

Instrumentation Laboratory IL BGGE (IL

1660) (28438)

Nova Stat Profile Ultra A (43108)

Nova Stat Profile Ultra B (43109)

Nova Stat Profile Ultra C (43110)

Nova Stat Profile Ultra E (43112)

Nova Stat Profile Ultra F (43115)

Nova Stat Profile Ultra G (43116)

Nova Stat Profile Ultra H (43117)

Nova Stat Profile Ultra I (43118)

Nova Stat Profile Ultra J (43119)

Nova Stat Profile Ultra K (43120)

Roche Cobas MICROS CT16 (55175)

Roche Cobas MICROS CT18 (55177)

Roche Cobas MICROS CT5 (55171)

Roche Cobas MICROS CT8 (55173)

Roche Cobas MICROS OT16 (55176)

Roche Cobas MICROS OT18 (55178)

Roche Cobas MICROS OT5 (55172)

Roche Cobas MICROS OT8 (55174)

SenDx 100 pH, Blood Gas and Electrolyte

Analysis System (58390)

Sysmex F–520 (58370)

Sysmex F–820 (58371)

Sysmex SF–3000 (58360)

Texas International Laboratories Hematil

18 (61205)

Analyte: Hemoglobin (2515)

Test System, Assay, Examination:

AVL OMNI Combi Analyzer (04609)

American Optical AO Hb-Meter

Hemoglobinometer (04620)

Becton Dickinson QBC AccuRead (07747)

BioChem Immunosystems Baker System

9100+ (07711)

BioChem Immunosystems Baker System

9110+ (07712)

BioChem Immunosystems Baker System

9118+ (07713)

BioChem Immunosystems Baker System

9120+ (07714)

Coulter MD II Series Analyzer (10318)

Danam Datacell 18MS (13356)

Instrumentation Laboratory IL682 COOximeter System (28368)

Johnson & Johnson CDI Ektachem DT 60

(31029)

Radiometer ABL 620 (55137)

Radiometer ABL System 615 (55197)

Radiometer ABL System 625 (55198)

Radiometer OSM 3 (55059)

Roche Cobas MICROS CT16 (55175)

Roche Cobas MICROS CT18 (55177)

Roche Cobas MICROS CT5 (55171)

Roche Cobas MICROS CT8 (55173)

Roche Cobas MICROS OT16 (55176)

Roche Cobas MICROS OT18 (55178)

Roche Cobas MICROS OT5 (55172)

Roche Cobas MICROS OT8 (55174)
35750 Federal Register / Vol. 61, No. 131 / Monday, July 8, 1996 / Notices

Sysmex F–520 (58370)

Sysmex F–820 (58371)

Sysmex SF–3000 (58360)

Texas International Laboratories Hematil

18 (61205)

Analyte: Leukocytes, Fecal (3723)

Test System, Assay, Examination:

All Methylene Blue Wet Mount Preps for

Fecal Leukocytes (04657)

Analyte: Lupus Anticoagulants (3728)

Test System, Assay, Examination:

Bio/Data Microsample Coagulation

Analyzer, MCA 310 (07597)

Analyte: Platelet Aggregation (4928)

Test System, Assay, Examination:

Centocor AggreStat (10328)

Analyte: Platelet Count (4908)

Test System, Assay, Examination:

Becton Dickinson QBC AccuRead (07747)

BioChem Immunosystems Baker System

9100+ (07711)

BioChem Immunosystems Baker System

9110+ (07712)

BioChem Immunosystems Baker System

9118+ (07713)

BioChem Immunosystems Baker System

9120+ (07714)

Coulter MD II Series Analyzer (10318)

Danam Datacell 18MS (13356)

Roche Cobas MICROS CT16 (55175)

Roche Cobas MICROS CT18 (55177)

Roche Cobas MICROS CT8 (55173)

Roche Cobas MICROS OT16 (55176)

Roche Cobas MICROS OT18 (55178)

Roche Cobas MICROS OT8 (55174)

Sysmex F–820 (58371)

Sysmex SF–3000 (58360)

Texas International Laboratories Hematil

18 (61205)

Analyte: Prothrombin Time (PT) (4922)

Test System, Assay, Examination:

Bio/Data Microsample Coagulation

Analyzer, MCA 310 (07597)

Instrumentation Laboratory IL ACL Futura

System (28395)

International Technidyne Factor VI Pt+

(28360)

International Technidyne Hemochron 400

HNPT (28355)

International Technidyne Hemochron 401

HNPT (28356)

International Technidyne Hemochron 800

HNPT (28357)

International Technidyne Hemochron 8000

HNPT (28359)

International Technidyne Hemochron 801

HNPT (28358)

International Technidyne ProTIME

Microcoagulation System (28387)

Medical Laboratory MLA Electra 1400C

(40208)

Analyte: Prothrombin Time Factor

Substitution (4976)

Test System, Assay, Examination:

Medical Laboratory MLA Electra 1400C

(40208)

Analyte: Red Blood Cell Count (Erythrocyte

Count) (RBC) (5502)

Test System, Assay, Examination:

BioChem Immunosystems Baker System

9100+ (07711)

BioChem Immunosystems Baker System

9110+ (07712)

BioChem Immunosystems Baker System

9118+ (07713)

BioChem Immunosystems Baker System

9120+ (07714)

Coulter MD II Series Analyzer (10318)

Danam Datacell 18MS (13356)

Roche Cobas MICROS CT16 (55175)

Roche Cobas MICROS CT18 (55177)

Roche Cobas MICROS CT5 (55171)

Roche Cobas MICROS CT8 (55173)

Roche Cobas MICROS OT16 (55176)

Roche Cobas MICROS OT18 (55178)

Roche Cobas MICROS OT5 (55172)

Roche Cobas MICROS OT8 (55174)

Sysmex F–520 (58370)

Sysmex F–820 (58371)

Sysmex SF–3000 (58360)

Texas International Laboratories Hematil

18 (61205)

Analyte: Reticulocyte Count (5506)

Test System, Assay, Examination:

Abbott Cell-Dyn 3500 R (04666)

Becton Dickinson FACSCalibur (with retic

count software) (07640)

Becton Dickinson FACSort (with retic

count software) (07638)

Analyte: Semen (5822)

Test System, Assay, Examination:

Medical Electronic Systems Sperm Quality

Analyzer (40221)

Analyte: Thrombin Time (6105)

Test System, Assay, Examination:

Bio/Data Microsample Coagulation

Analyzer, MCA 310 (07597)

Medical Laboratory MLA Electra 1400C

(40208)

Analyte: White Blood Cell Count (Leukocyte

Count) (WBC) (7002)

Test System, Assay, Examination:

Becton Dickinson QBC AccuRead (07747)

BioChem Immunosystems Baker System

9100+ (07711)

BioChem Immunosystems Baker System

9110+ (07712)

BioChem Immunosystems Baker System

9118+ (07713)

BioChem Immunosystems Baker System

9120+ (07714)

Coulter MD II Series Analyzer (10318)

Danam Datacell 18MS (13356)

Roche Cobas MICROS CT16 (55175)

Roche Cobas MICROS CT18 (55177)

Roche Cobas MICROS CT5 (55171)

Roche Cobas MICROS CT8 (55173)

Roche Cobas MICROS OT16 (55176)

Roche Cobas MICROS OT18 (55178)

Roche Cobas MICROS OT5 (55172)

Roche Cobas MICROS OT8 (55174)

Sysmex F–520 (58370)

Sysmex F–820 (58371)

Sysmex SF–3000 (58360)

Texas International Laboratories Hematil

18 (61205)

Analyte: White Blood Cell Differential (WBC

Diff) (7001)

Test System, Assay, Examination:

Becton Dickinson QBC AccuRead (07747)

BioChem Immunosystems Baker System

9100+ (07711)

BioChem Immunosystems Baker System

9110+ (07712)

BioChem Immunosystems Baker System

9118+ (07713)

BioChem Immunosystems Baker System

9120+ (07714)

Coulter MD II Series Analyzer (10318)

Danam Datacell 18MS (13356)

Roche Cobas MICROS CT16 (55175)

Roche Cobas MICROS CT18 (55177)

Roche Cobas MICROS OT16 (55176)

Roche Cobas MICROS OT18 (55178)

Sysmex F–820 (58371)

Sysmex SF–3000 (58360)

Texas International Laboratories Hematil

18 (61205)

Speciality/Subspeciality: Mycology

Analyte: Yeast, C. Albicans Only (7602)

Test System, Assay, Examination:

BioMerieux Vitek Albicans ID (07773)

Speciality/Subspeciality: Toxicology /

TDM

Analyte: Acetaminophen (0406)

Test System, Assay, Examination:

Abbott AxSYM (04532)

Johnson & Johnson CDI Ektachem 250

(31019)

Johnson & Johnson CDI Ektachem 500

(31021)

Johnson & Johnson CDI Ektachem 550 XRC

(31022)

Johnson & Johnson CDI Ektachem 700

(31023)

Johnson & Johnson CDI Ektachem 750 XRC

(31027)

Johnson & Johnson CDI Ektachem 950 IRC

(31028)

Roche Cobas INTEGRA (55179)

Analyte: Amikacin (0425)

Test System, Assay, Examination:

Roche Cobas INTEGRA (55179)

Analyte: Amphetamines (0428)

Test System, Assay, Examination:

Beckman Synchron CX 4 (CEDIA DAU/

automated curve) (07754)

Beckman Synchron CX 4 Delta (07762)

Beckman Synchron CX 5 (CEDIA DAU/

automated curve) (07755)

Beckman Synchron CX 5 Delta (07763)

Beckman Synchron CX 7 (CEDIA DAU/

automated curve) (07756)

Beckman Synchron CX 7 Delta (07764)

Boehringer Mannheim Hitachi 704 (CEDIA

DAU/automated curve) (07757)

Boehringer Mannheim Hitachi 717 (CEDIA

DAU/automated curve) (07758)

Boehringer Mannheim Hitachi 747 (CEDIA

DAU/automated curve) (07759)

Boehringer Mannheim Hitachi 911 (CEDIA

DAU/automated curve) (07760)

Boehringer Mannheim Hitachi 917 (07765)

Du Pont Dimension AR (13087)

Du Pont Dimension XL (13355)

Fingerprint Biotech FINGERPRINT–DOA

Screening Device (19023)

Olympus AU 5000 (CEDIA DAU/

automated curve) (46217)

Princeton BioMeditech AbuSign AMP

(49150)

Princeton BioMeditech AccuSign AMP

(49152)
Federal Register / Vol. 61, No. 131 / Monday, July 8, 1996 / Notices 35751

Princeton BioMeditech BioSign AMP

(49153)

Princeton BioMeditech DOA–AMP (49151)

Roche Cobas INTEGRA (55179)

Worldwide Medical First Check AMP

(70187)

Worldwide Medical First Check Panel 4

(TCH/OPI/COC/AMP) (70188)

Analyte: Barbiturates (0701)

Test System, Assay, Examination:

Abbott AxSYM (04532)

Beckman Synchron CX 4 (CEDIA DAU/

automated curve) (07754)

Beckman Synchron CX 4 Delta (07762)

Beckman Synchron CX 5 (CEDIA DAU/

automated curve) (07755)

Beckman Synchron CX 5 Delta (07763)

Beckman Synchron CX 7 (CEDIA DAU/

automated curve) (07756)

Beckman Synchron CX 7 Delta (07764)

Boehringer Mannheim Hitachi 704 (CEDIA

DAU/automated curve) (07757)

Boehringer Mannheim Hitachi 717 (CEDIA

DAU/automated curve) (07758)

Boehringer Mannheim Hitachi 747 (CEDIA

DAU/automated curve) (07759)

Boehringer Mannheim Hitachi 911 (07377)

Boehringer Mannheim Hitachi 911 (CEDIA

DAU/automated curve) (07760)

Boehringer Mannheim Hitachi 917 (07765)

Du Pont Dimension AR (13087)

Du Pont Dimension XL (13355)

Olympus AU 5000 (CEDIA DAU/

automated curve) (46217)

Roche Cobas INTEGRA (55179)

Analyte: Benzodiazepines (0702)

Test System, Assay, Examination:

Beckman Synchron CX 4 (CEDIA DAU/

automated curve) (07754)

Beckman Synchron CX 4 Delta (07762)

Beckman Synchron CX 5 (CEDIA DAU/

automated curve) (07755)

Beckman Synchron CX 5 Delta (07763)

Beckman Synchron CX 7 (CEDIA DAU/

automated curve) (07756)

Beckman Synchron CX 7 Delta (07764)

Boehringer Mannheim Hitachi 704 (CEDIA

DAU/automated curve) (07757)

Boehringer Mannheim Hitachi 717 (CEDIA

DAU/automated curve) (07758)

Boehringer Mannheim Hitachi 747 (CEDIA

DAU/automated curve) (07759)

Boehringer Mannheim Hitachi 911 (07377)

Boehringer Mannheim Hitachi 911 (CEDIA

DAU/automated curve) (07760)

Boehringer Mannheim Hitachi 917 (07765)

Du Pont Dimension AR (13087)

Du Pont Dimension XL (13355)

Olympus AU 5000 (CEDIA DAU/

automated curve) (46217)

Roche Cobas INTEGRA (55179)

Sun Biomedical Labs Visualine II

Benzodiazepines (58389)

Analyte: Cannabinoids (THC) (1009)

Test System, Assay, Examination:

Beckman Synchron CX 4 (CEDIA DAU/

automated curve) (07754)

Beckman Synchron CX 4 Delta (07762)

Beckman Synchron CX 5 (CEDIA DAU/

automated curve) (07755)

Beckman Synchron CX 5 Delta (07763)

Beckman Synchron CX 7 (CEDIA DAU/

automated curve) (07756)

Beckman Synchron CX 7 Delta (07764)

Boehringer Mannheim FRONTLINE

CANNABIS (07771)

Boehringer Mannheim Hitachi 704 (CEDIA

DAU/automated curve) (07757)

Boehringer Mannheim Hitachi 717 (CEDIA

DAU/automated curve) (07758)

Boehringer Mannheim Hitachi 747 (CEDIA

DAU/automated curve) (07759)

Boehringer Mannheim Hitachi 911 (07377)

Boehringer Mannheim Hitachi 911 (CEDIA

DAU/automated curve) (07760)

Boehringer Mannheim Hitachi 917 (07765)

Du Pont Dimension AR (13087)

Du Pont Dimension XL (13355)

Fingerprint Biotech FINGERPRINT–DOA

Screening Device (19023)

Olympus AU 5000 (CEDIA DAU/

automated curve) (46217)

Princeton BioMeditech AbuSign DOA 2

(THC/COC) (49160)

Princeton BioMeditech AbuSign DOA 3

(THC/OPI/COC) (49161)

Princeton BioMeditech AbuSign DOA 4

(THC/OPI/COC/MET) (49162)

Roche Cobas INTEGRA (55179)

Sun Biomedical Labs Visualine II

Cannabinoids (58364)

Worldwide Medical First Check Panel 2

(THC/COC) (70179)

Worldwide Medical First Check Panel 3

(THC/OPI/COC) (70180)

Worldwide Medical First Check Panel 4

(TCH/OPI/COC/AMP) (70188)

Worldwide Medical First Check Panel 4

(THC/OPI/COC/MET) (70178)

Worldwide Medical First Check THC

(70185)

Analyte: Carbamazepine (1010)

Test System, Assay, Examination:

Beckman Synchron CX 4 Delta (07762)

Beckman Synchron CX 5 Delta (07763)

Beckman Synchron CX 7 Delta (07764)

Boehringer Mannheim Hitachi 747 (07166)

Boehringer Mannheim Hitachi 917 (07765)

Olympus AU 5000 (46001)

Olympus AU 5200 (46143)

Roche Cobas INTEGRA (55179)

Analyte: Carboxyhemoglobin (1012)

Test System, Assay, Examination:

AVL OMNI Combi Analyzer (04609)

Instrumentation Laboratory IL682 COOximeter System (28368)

Nova Co-Oximeter (43114)

Radiometer ABL System 625 (55198)

Analyte: Cocaine Metabolites (1023)

Test System, Assay, Examination:

Abbott AxSYM (04532)

Applied Biotech SureStep Drug Screen

Cocaine Test (04665)

Beckman Synchron CX 4 (CEDIA DAU/

automated curve) (07754)

Beckman Synchron CX 4 Delta (07762)

Beckman Synchron CX 5 (CEDIA DAU/

automated curve) (07755)

Beckman Synchron CX 5 Delta (07763)

Beckman Synchron CX 7 (CEDIA DAU/

automated curve) (07756)

Beckman Synchron CX 7 Delta (07764)

Boehringer Mannheim FRONTLINE

COCAINE (07770)

Boehringer Mannheim Hitachi 704 (CEDIA

DAU/automated curve) (07757)

Boehringer Mannheim Hitachi 717 (CEDIA

DAU/automated curve) (07758)

Boehringer Mannheim Hitachi 747 (CEDIA

DAU/automated curve) (07759)

Boehringer Mannheim Hitachi 911 (CEDIA

DAU/automated curve) (07760)

Boehringer Mannheim Hitachi 917 (07765)

Du Pont Dimension AR (13087)

Du Pont Dimension XL (13355)

Fingerprint Biotech FINGERPRINT-DOA

Screening Device (19023)

Olympus AU 5000 (CEDIA DAU/

automated curve) (46217)

Princeton BioMeditech AbuSign DOA 2

(THC/COC) (49160)

Princeton BioMeditech AbuSign DOA 3

(THC/OPI/COC) (49161)

Princeton BioMeditech AbuSign DOA 4

(THC/OPI/COC/MET) (49162)

Roche Cobas INTEGRA (55179)

Sun Biomedical Labs Visualine II Cocaine

(58361)

Technical Chem. & Prod. One Step Urine

DoA Cocaine (61208)

Worldwide Medical First Check COC

(70184)

Worldwide Medical First Check Panel 2

(THC/COC) (70179)

Worldwide Medical First Check Panel 3

(THC/OPI/COC) (70180)

Worldwide Medical First Check Panel 4

(TCH/OPI/COC/AMP) (70188)

Worldwide Medical First Check Panel 4

(THC/OPI/COC/MET) (70178)

Analyte: Digitoxin (1303)

Test System, Assay, Examination:

Abbott AxSYM (04532)

Analyte: Digoxin (1304)

Test System, Assay, Examination:

Abbott IMX (04056)

Beckman Synchron CX 4 (Emit 2000)

(07675)

Beckman Synchron CX 4 CE (Emit 2000)

(07677)

Beckman Synchron CX 4 Delta (07762)

Beckman Synchron CX 5 (Emit 2000)

(07679)

Beckman Synchron CX 5 CE (Emit 2000)

(07681)

Beckman Synchron CX 5 Delta (07763)

Beckman Synchron CX 7 (Emit 2000)

(07683)

Beckman Synchron CX 7 Delta (07764)

Bio-Chem Laboratory Systems ATAC 8000

(07658)

Boehringer Mannheim Hitachi 704 (Emit

2000) (07669)

Boehringer Mannheim Hitachi 717 (Emit

2000) (07671)

Boehringer Mannheim Hitachi 911 (Emit

2000) (07673)

Boehringer Mannheim Hitachi 917 (07765)

Du Pont ACA III (DGN A) (13390)

Du Pont ACA IV (DGN A) (13391)

Du Pont ACA Star (DGN A) (13400)

Du Pont ACA V (DGN A) (13392)

Instrumentation Laboratory IL Monarch

1000(IL Test Digoxin) (28400)

Instrumentation Laboratory IL Monarch

2000(IL Test Digoxin) (28401)

Instrumentation Laboratory IL Monarch

Plus(IL Test Digoxin) (28402)

Instrumentation Laboratory ILAB 1800

(28323)

Instrumentation Laboratory ILAB 900

(28322)
35752 Federal Register / Vol. 61, No. 131 / Monday, July 8, 1996 / Notices

Jonhson & Johnson CDI Ektachem 250

(31019)

Jonhson & Johnson CDI Ektachem 950 IRC

(31028)

Roche Cobas INTEGRA (55179)

Roche Cobas Mira (Emit 2000) (55166)

Roche Cobas Mira Plus (Emit 2000) (55170)

Roche Cobas Mira S (Emit 2000) (55168)

Technicon RA 1000 (Bayer Digoxin DGN)

(61200)

Technicon RA 2000 (Bayer Digoxin DGN)

(61201)

Technicon RA 500 (Bayer Digoxin DGN)

(61202)

Technicon RA XT (Bayer Digoxin DGN)

(61203)

Analyte: Ethanol (Alcohol) (1608)

Test System, Assay, Examination:

Abbott AxSYM (04532)

Beckman Synchron CX 4 Delta (07762)

Beckman Synchron CX 5 Delta (07763)

Beckman Synchron CX 7 Delta (07764)

Boehringer Mannheim Hitachi 704 (whole

blood) (07738)

Boehringer Mannheim Hitachi 717 (whole

blood) (07739)

Boehringer Mannheim Hitachi 737 (whole

blood) (07740)

Boehringer Mannheim Hitachi 747 (whole

blood) (07741)

Boehringer Mannheim Hitachi 911 (whole

blood) (07742)

Boehringer Mannheim Hitachi 914 (whole

blood) (07743)

Boehringer Mannheim Hitachi 917 (07765)

Jonhson & Johnson CDI Ektachem 500

(31021)

Jonhson & Johnson CDI Ektachem 700

(31023)

Jonhson & Johnson CDI Ektachem 700 XR

(31026)

Jonhson & Johnson CDI Ektachem 950 IRC

(31028)

Roche Cobas INTEGRA (55179)

Analyte: Ethanol (Alcohol), Whole Blood

(1632)

Test System, Assay, Examination:

Boehringer Mannheim Hitachi 917 (07765)

Analyte: Gentamicin (2202)

Test System, Assay, Examination:

Beckman Synchron CX 4 Delta (07762)

Beckman Synchron CX 5 Delta (07763)

Beckman Synchron CX 7 Delta (07764)

Boehringer Mannheim Hitachi 917 (07765)

Ciba Corning ACS 180 (10046)

Roche Cobas INTEGRA (55179)

Analyte: Lidocaine (3710)

Test System, Assay, Examination:

Roche Cobas INTEGRA (55179)

Analyte: Lithium (3712)

Test System, Assay, Examination:

Johnson & Johnson CDI Ektachem 250

(31019)

Johnson & Johnson CDI Ektachem 400

(31020)

Johnson & Johnson CDI Ektachem 500

(31021)

Johnson & Johnson CDI Ektachem 550 XRC

(31022)

Johnson & Johnson CDI Ektachem 700

(31023)

Johnson & Johnson CDI Ektachem 700

Analyzer C Series (31024)

Johnson & Johnson CDI Ektachem 700 P

(31025)

Johnson & Johnson CDI Ektachem 700 XR

(31026)

Johnson & Johnson CDI Ektachem 750 XRC

(31027)

Johnson & Johnson CDI Ektachem 950 IRC

(31028)

Johnson & Johnson CDI Ektachem DT 60

(31029)

Johnson & Johnson CDI Ektachem DT II

(31030)

Johnson & Johnson CDI Ektachem DT SC

Module (31031)

Johnson & Johnson CDI Ektachem DTE

Module (31033)

Roche Cobas INTEGRA (55179)

Analyte: Lysergic Acid Diethylamide (LSD)

(3715)

Test System, Assay, Examination:

Boehringer Mannheim Hitachi 911 (CEDIA

DAU/automated curve) (07760)

Analyte: Methadone (4003)

Test System, Assay, Examination:

Abbott AxSYM (04532)

Beckman Synchron CX 4 Delta (07762)

Beckman Synchron CX 5 Delta (07763)

Beckman Synchron CX 7 Delta (07764)

Boehringer Mannheim Hitachi 704 (CEDIA

DAU/automated curve) (07757)

Boehringer Mannheim Hitachi 717 (CEDIA

DAU/automated curve) (07758)

Boehringer Mannheim Hitachi 747 (CEDIA

DAU/automated curve) (07759)

Boehringer Mannheim Hitachi 911 (CEDIA

DAU/automated curve) (07760)

Boehringer Mannheim Hitachi 917 (07765)

Boehringer Mannheim Hitachi 917 (CEDIA

DAU/automated curve) (07769)

Du Pont Dimension AR (13087)

Du Pont Dimension XL (13355)

Roche Cobas INTEGRA (55179)

Analyte: Methamphetamine/Amphetamine

(4036)

Test System, Assay, Examination:

Abbott AxSYM (04532)

Analyte: Methamphetamines (4004)

Test System, Assay, Examination:

Princeton BioMeditech AbuSign DOA 4

(THC/OPI/COC/MET) (49162)

Princeton BioMeditech AccuSign MET

(49163)

Worldwide Medical First Check Panel 4

(THC/OPI/COC/MET) (70178)

Analyte: Methaqualone (4005)

Test System, Assay, Examination:

Beckman Synchron CX 4 Delta (07762)

Beckman Synchron CX 5 Delta (07763)

Beckman Synchron CX 7 Delta (07764)

Roche Cobas INTEGRA (55179)

Analyte: N-Acetylprocainamide (NAPA)

(4301)

Test System, Assay, Examination:

Abbott AxSYM (04532)

Roche Cobas INTEGRA (55179)

Analyte: Opiates (4601)

Test System, Assay, Examination:

Abbott AxSYM (04532)

Beckman Synchron CX 4 (CEDIA DAU/

automated curve) (07754)

Beckman Synchron CX 4 Delta (07762)

Beckman Synchron CX 5 (CEDIA DAU/

automated curve) (07755)

Beckman Synchron CX 5 Delta (07763)

Beckman Synchron CX 7 (CEDIA DAU/

automated curve) (07756)

Beckman Synchron CX 7 Delta (07764)

Boehringer Mannheim FRONTLINE

OPIATES (07772)

Boehringer Mannheim Hitachi 704 (CEDIA

DAU/automated curve) (07757)

Boehringer Mannheim Hitachi 717 (CEDIA

DAU/automated curve) (07758)

Boehringer Mannheim Hitachi 747 (CEDIA

DAU/automated curve) (07759)

Boehringer Mannheim Hitachi 911 (CEDIA

DAU/automated curve) (07760)

Boehringer Mannheim Hitachi 917 (07765)

Du Pont Dimension AR (13087)

Du Pont Dimension XL (13355)

Fingerprint Biotech FINGERPRINT—DOA

Screening Device (19023)

Olympus AU 5000 (CEDIA DAU/

automated curve) (46217)

Princeton BioMeditech AbuSign DOA 3

(THC/OPI/COC) (49161)

Princeton BioMeditech AbuSign DOA 4

(THC/OPI/COC/MET) (49162)

Roche Cobas INTEGRA (55179)

Technical Chem. & Prod. One Step Urine

DoA Opiate (61207)

Worldwide Medical First Check MOP

(70186)

Worldwide Medical First Check Panel 3

(THC/OPI/COC) (70180)

Worldwide Medical First Check Panel 4

(TCH/OPI/COC/AMP) (70188)

Worldwide Medical First Check Panel 4

(THC/OPI/COC/MET) (70178)

Analyte: Phencyclidine (PCP) (4901)

Test System, Assay, Examination:

Abbott AxSYM (04532)

Beckman Synchron CX 4 (CEDIA DAU/

automated curve) (07754)

Beckman Synchron CX 4 Delta (07762)

Beckman Synchron CX 5 (CEDIA DAU/

automated curve) (07755)

Beckman Synchron CX 5 Delta (07763)

Beckman Synchron CX 7 (CEDIA DAU/

automated curve) (07756)

Beckman Synchron CX 7 Delta (07764)

Boehringer Mannheim Hitachi 704 (CEDIA

DAU/automated curve) (07757)

Boehringer Mannheim Hitachi 717 (CEDIA

DAU/automated curve) (07758)

Boehringer Mannheim Hitachi 747 (CEDIA

DAU/automated curve) (07759)

Boehringer Mannheim Hitachi 911 (07377)

Boehringer Mannheim Hitachi 911 (CEDIA

DAU/automated curve) (07760)

Boehringer Mannheim Hitachi 917 (07765)

Du Pont Dimension AR (13087)

Du Pont Dimension XL (13355)

Fingerprint Biotech FINGERPRINT—DOA

Screening Device (19023)

Olympus AU 5000 (CEDIA DAU/

automated curve) (46217)

Roche Cobas INTEGRA (55179)

Analyte: Phenobarbital (4902)

Test System, Assay, Examination:

Beckman Synchron CX 4 Delta (07762)

Beckman Synchron CX 5 Delta (07763)
Federal Register / Vol. 61, No. 131 / Monday, July 8, 1996 / Notices 35753

Beckman Synchron CX 7 Delta (07764)

Boehringer Mannheim Hitachi 917 (07765)

Roche Cobas INTEGRA (55179)

Analyte: Phenytoin (4903)

Test System, Assay, Examination:

Beckman Synchron CX 4 Delta (07762)

Beckman Synchron CX 5 Delta (07763)

Beckman Synchron CX 7 Delta (07764)

Boehringer Mannheim Hitachi 917 (07765)

Instrumentation Laboratory ILAB 1800

(28323)

Instrumentation Laboratory ILAB 900

(28322)

Johnson & Johnson CDI Ektachem 250

(31019)

Johnson & Johnson CDI Ektachem 950 IRC

(31028)

Roche Cobas INTEGRA (55179)

Analyte: Phenytoin, Free (4904)

Test System, Assay, Examination:

Roche Cobas FARA II (55041)

Roche Cobas INTEGRA (55179)

Analyte: Primidone (4912)

Test System, Assay, Examination:

Roche Cobas INTEGRA (55179)

Analyte: Procainamide (4913)

Test System, Assay, Examination:

Abbott AxSYM (04532)

PB Diagnostics Systems OPUS Magnum

(49097)

PB Diagnostics Systems OPUS PLUS

(49098)

Roche Cobas INTEGRA (55179)

Analyte: Propoxyphene (4917)

Test System, Assay, Examination:

Beckman Synchron CX 4 (CEDIA DAU/

automated curve) (07754)

Beckman Synchron CX 4 Delta (07762)

Beckman Synchron CX 5 (CEDIA DAU/

automated curve) (07755)

Beckman Synchron CX 5 Delta (07763)

Beckman Synchron CX 7 (CEDIA DAU/

automated curve) (07756)

Beckman Synchron CX 7 Delta (07764)

Boehringer Mannheim Hitachi 704 (CEDIA

DAU/automated curve) (07757)

Boehringer Mannheim Hitachi 717 (CEDIA

DAU/automated curve) (07758)

Boehringer Mannheim Hitachi 747 (CEDIA

DAU/automated curve) (07759)

Boehringer Mannheim Hitachi 911 (07377)

Boehringer Mannheim Hitachi 911 (CEDIA

DAU/automated curve) (07760)

Boehringer Mannheim Hitachi 917 (07765)

Roche Cobas INTEGRA (55179)

Analyte: Quinidine (5202)

Test System, Assay, Examination:

Roche Cobas INTEGRA (55179)

Analyte: Salicylates (5801)

Test System, Assay, Examination:

Abbott AxSYM (04532)

Beckman Synchron CX 4 Delta (07762)

Beckman Synchron CX 5 Delta (07763)

Beckman Synchron CX 7 Delta (07764)

Boehringer Mannheim Hitachi 917 (07765)

Johnson & Johnson CDI Ektachem 250

(31019)

Johnson & Johnson CDI Ektachem 500

(31021)

Johnson & Johnson CDI Ektachem 550 XRC

(31022)

Johnson & Johnson CDI Ektachem 700

(31023)

Johnson & Johnson CDI Ektachem 700

Analyzer C Series (31024)

Johnson & Johnson CDI Ektachem 700 XR

(31026)

Johnson & Johnson CDI Ektachem 750 XRC

(31027)

Johnson & Johnson CDI Ektachem 950 IRC

(31028)

Olympus AU 5000 (46001)

Olympus AU 5200 (46143)

Roche Cobas INTEGRA (55179)

Analyte: Theophylline (6104)

Test System, Assay, Examination:

Beckman Synchron CX 4 Delta (07762)

Beckman Synchron CX 5 Delta (07763)

Beckman Synchron CX 7 Delta (07764)

Bio-Chem Laboratory Systems ATAC 8000

(07658)

Boehringer Mannheim Hitachi 917 (07765)

Ciba Corning ACS 180 (10046)

Cirrus Diagnostics Immulite (10159)

Johnson & Johnson CDI Ektachem 250

(31019)

Johnson & Johnson CDI Ektachem 500

(31021)

Johnson & Johnson CDI Ektachem 550 XRC

(31022)

Johnson & Johnson CDI Ektachem 700

(31023)

Johnson & Johnson CDI Ektachem 700

Analyzer C Series (31024)

Johnson & Johnson CDI Ektachem 700 XR

(31026)

Johnson & Johnson CDI Ektachem 750 XRC

(31027)

Johnson & Johnson CDI Ektachem 950 IRC

(31028)

Johnson & Johnson CDI Ektachem DT II

(31030)

Johnson & Johnson CDI Ektachem DT SC

Module (31031)

Roche Cobas INTEGRA (55179)

Analyte: Tobramycin (6112)

Test System, Assay, Examination:

Beckman Synchron CX 4 Delta (07762)

Beckman Synchron CX 5 Delta (07763)

Beckman Synchron CX 7 Delta (07764)

Boehringer Mannheim Hitachi 917 (07765)

Analyte: Tricyclic Antidepressants (6117)

Test System, Assay, Examination:

Abbott AxSYM (04532)

Analyte: Valproic Acid (6701)

Test System, Assay, Examination:

Boehringer Mannheim Hitachi 917 (07765)

Roche Cobas INTEGRA (55179)

Analyte: Valproic Acid, Free (6702)

Test System, Assay, Examination:

Roche Cobas FARA II (55041)

Roche Cobas INTEGRA (55179)

Analyte: Vancomycin (6703)

Test System, Assay, Examination:

Ciba Corning ACS 180 (10046)

Roche Cobas INTEGRA (55179)

Speciality/Subspeciality: Urinalysis

Analyte: Urinary Sediment Microscopic

Elements (6405)

Test System, Assay, Examination:

DAVSTAR Cen-Slide System (13396)

Dia Sys R/S 1000 (13397)

Dia Sys R/S 2000 (13398)

Analyte: Urine Qualitative Dipstick

Chemistries (6406)

Test System, Assay, Examination:

Boehringer Mannheim Chemstrip Criterion

Urine Analyzer (07716)

Speciality/Subspeciality: Virology

Analyte: Herpes Simplex (2529)

Test System, Assay, Examination:

Johnson & Johnson CDI SureCell (direct

antigen/visual) (31063)

Analyte: Rotavirus (5509)

Test System, Assay, Examination:

Vitek Systems Vidas (67038)

Complexity: High

Speciality/Subspeciality: Bacteriology

Analyte: Aerobic &/or Anaerobic OrganismsUnlimited Sources (0412)

Test System, Assay, Examination:

AB Biodisk Etest (including culture)

(04592)

All Antimicrobial Suscept. (disk diffusion/

dilution) fr cult (04637)

All Conventional Organism Identification

(ID) from culture (04636)

Becton Dickinson BBL CRYSTAL ANR ID

System (inc. culture) (07561)

Difco DrySlide NEISSERIA (including

culture) (13407)

Analyte: Aerobic Organisms From Urine

Specimens Only (0468)

Test System, Assay, Examination:

Culture Kits, Inc. Uri-Two

(nonconfirmatory ID) (10333)

Analyte: Chlamydia (1016)

Test System, Assay, Examination:

Abbott IMX Select (04229)

Abbott LCx Chlamydia trachomatis Assay

(04541)

DAKO IDEIA Chlamydia Blocking Reagents

(13322)

Sanofi Pasteur Access Immunoassay

System (58257)

Analyte: Enterococcus (1612)

Test System, Assay, Examination:

Becton Dickinson Enterococcus Screening

Test (inc. culture) (07715)

Analyte: Escherichia Coli (1604)

Test System, Assay, Examination:

LMD Laboratories E. coli 0157 ELISA

Assay (dir. ag/spectro) (37092)

LMD Laboratories E. coli 0157 ELISA

Assay (dir. ag/visual) (37091)

Meridian Premier EHEC

(spectrophotometric) (40205)

Meridian Premier EHEC (visual) (40204)

Analyte: Haemophilus Influenzae, Type B

(2510)

Test System, Assay, Examination:

Becton Dickinson Drtgen Meningitis

Combo (inc. culture) (07726)

Analyte: Moraxella Catarrhalis (4037)

Test System, Assay, Examination:
35754 Federal Register / Vol. 61, No. 131 / Monday, July 8, 1996 / Notices

Difco DrySlide CATARRALIS (including

culture) (13408)

Analyte: Neisseria Gonorrhoeae (4302)

Test System, Assay, Examination:

Abbott LCx Neisseria gonorrhoeae Assay

(04545)

Analyte: Neisseria Meningitidis, Group A

(4304)

Test System, Assay, Examination:

Becton Dickinson Drtgen Meningitis

Combo (inc. culture) (07726)

Becton Dickinson Drtgen Neisseria

Meningitis (inc. culture) (07727)

Analyte: Neisseria Meningitidis, Group B

(4306)

Test System, Assay, Examination:

Becton Dickinson Drtgen Meningitis

Combo (inc. culture) (07726)

Analyte: Neisseria Meningitidis, Group C

(4308)

Test System, Assay, Examination:

Becton Dickinson Drtgen Meningitis

Combo (inc. culture) (07726)

Becton Dickinson Drtgen Neisseria

Meningitis (inc. culture) (07727)

Analyte: Neisseria Meningitidis, Group

W135 (4311)

Test System, Assay, Examination:

Becton Dickinson Drtgen Meningitis

Combo (inc. culture) (07726)

Becton Dickinson Drtgen Neisseria

Meningitis (inc. culture) (07727)

Analyte: Neisseria Meningitidis, Group Y

(4312)

Test System, Assay, Examination:

Becton Dickinson Drtgen Meningitis

Combo (inc. culture) (07726)

Becton Dickinson Drtgen Neisseria

Meningitis (inc. culture) (07727)

Analyte: Salmonella (5802)

Test System, Assay, Examination:

SA Scientific SAS Salmonella H Antisera

(including culture) (58363)

Analyte: Shigella (5804)

Test System, Assay, Examination:

SA Scientific SAS Shigella Antisera

(including culture) (58387)

Analyte: Staphylococcus (5807)

Test System, Assay, Examination:

Murex Staphaurex Plus (including culture)

(40200)

Analyte: Streptococcus Pneumoniae (5808)

Test System, Assay, Examination:

Becton Dickinson Drtgen Meningitis

Combo (inc. culture) (07726)

Analyte: Streptococcus, Group A (5810)

Test System, Assay, Examination:

Abbott TestPack +Plus Strep A with OBC

(inc. culture) (04626)

Becton Dickinson Directigen 1–2–3 Group

A Strep (inc cult.) (07662)

Johnson & Johnson CDI SureCell (including

culture) (31065)

Analyte: Streptococcus, Group B (5811)

Test System, Assay, Examination:

Becton Dickinson Drtgen Meningitis

Combo (inc. culture) (07726)

Speciality/Subspeciality: Endocrinology

Analyte: 17 Alpha-OH Progesterone (0109)

Test System, Assay, Examination:

Neometrics ACCUSCREEN 17alphahydroxyprogesterone RIA Kit (43105)

Analyte: 5-Hydroxyindolacetic Acid, Urine

(5–HIAA) (0101)

Test System, Assay, Examination:

Bio-Rad Urinary 5–HIAA by HPLC (07687)

Analyte: Androstenedione (0460)

Test System, Assay, Examination:

Diagnostic Products Corp. Coat-A-Count

Dir. Androstenedione (13411)

Analyte: Angiotensin I (0479)

Test System, Assay, Examination:

Pharmaceutical Discovery A–I

Photodiagnostic (49155)

Analyte: Angiotensin II (0520)

Test System, Assay, Examination:

ALPCO Angiotensin II RIA (04631)

Analyte: Calcitonin (1041)

Test System, Assay, Examination:

CIS–US ELSA–hCT (10312)

Nichols Institute Chemiluminescence

Calcitonin Assay (43113)

Analyte: Catecholamines, Urine (1055)

Test System, Assay, Examination:

Bio-Rad MDMS/CDMS (07778)

Analyte: Collagen Type I, C-telopeptides

(1131)

Test System, Assay, Examination:

Diagnostic Systems DSL 10–1700 ACTIVE

CrossLaps ELISA (13416)

Analyte: Collagen Type I, Crosslink

Deoxypyridinoline (Dpd) (1127)

Test System, Assay, Examination:

Metra Biosystems PYRILINKS–D (40251)

Analyte: Collagen Type I, Crosslink Ntelopeptides (NTx) (1125)

Test System, Assay, Examination:

Ostex International Osteomark (46193)

Analyte: Collagen Type I, Crosslink

Pyridinium (Pyd, Dpd) (1126)

Test System, Assay, Examination:

Metra Biosystems PYRILINKS (40250)

Metra Biosystems PYRILINKS Polyclonal

(40252)

Analyte: Cortisol, Urine (Extraction

Procedure) (1095)

Test System, Assay, Examination:

Ciba Corning ACS 180 (10046)

Analyte: Dehydroepiandrosterone (DHEA)

(1309)

Test System, Assay, Examination:

Diagnostic Systems DSL 10–9000 ACTIVE

DHEA EIA (13410)

Analyte: Estradiol (1605)

Test System, Assay, Examination:

Diagnostic Systems Ultra Sensitive

Estradiol RIA (13412)

Analyte: Estriol-unconjugated (1607)

Test System, Assay, Examination:

Diagnostic Systems ACTIVE Ultra-Sens.

Unconjugated Estriol (13409)

Analyte: Follicle Stimulating Hormone (FSH)

(1908)

Test System, Assay, Examination:

Johnson & Johnson CDL Amerlite Analyzer

(31016)

Analyte: HCG, Beta, Serum, Quantitative

(2502)

Test System, Assay, Examination:

Johnson & Johnson CDL Amerlite Analyzer

(31016)

Analyte: HCG, Total, Serum, Quantitative

(2555)

Test System, Assay, Examination:

Diagnostic Systems DSL 8300 ACTIVE

INTACT hCG IRMA (13419)

Analyte: HCG, Urine, Quantitative (2534)

Test System, Assay, Examination:

Johnson & Johnson CDL Amerlite Analyzer

(31016)

Analyte: Human Growth Hormone (GH)

(2547)

Test System, Assay, Examination:

Diagnostic Systems DSL 10–1900 ACTIVE

hGH ELISA (13415)

Analyte: Insulin-like Growth Factor-1 (IGF–

1) (2818)

Test System, Assay, Examination:

Diagnostic Systems Active IGF–1 ELISA

(13381)

Diagnostic Systems DSL 2800 ACTIVE Noextrac.IGF–1 C–T IRMA (13418)

ImmunoDiagnostic Systems OCTEIA IGF–

1 IEMA Kit (28385)

Nichols Institute Insulin-Like Growth

Factor I (IGF–I,IRMA) (43106)

Analyte: Insulin-like Growth Factor Bind.

Protein3 (IGFBP–3) (2832)

Test System, Assay, Examination:

Diagnostic Systems Active IGFBP–3 ELISA

(13382)

Nichols Institute IGFBP–3

Radioimmunoassay Kit (43104)

Analyte: Luteinizing Hormone (LH) (3713)

Test System, Assay, Examination:

Diagnostic Systems DSL 4600 ACTIVE LH

Coated-Tube IRMA (13417)

Nichols Institute Chemiluminescence LH

Assay (43107)

Analyte: Metanephrines, Urine (4025)

Test System, Assay, Examination:

Bioanalytical Systems Urinary

Metanephrine Kit (07686)

Analyte: Parathyroid Hormone—Intact

(4924)

Test System, Assay, Examination:

CIS–US ELSA–PTH (10299)

Diagnostic Systems Active I–PTH ELISA

Kit (13402)

Scantibodies Laboratory Intact PTH Assay

(58348)

Analyte: Prolactin (4915)

Test System, Assay, Examination:
Federal Register / Vol. 61, No. 131 / Monday, July 8, 1996 / Notices 35755

Diagnostic Systems DSL 4500 ACTIVE

Prolactin Ctd-Tube IRMA (13414)

Johnson & Johnson CDL Amerlite Analyzer

(31016)

Analyte: Testosterone, Free (6122)

Test System, Assay, Examination:

Diagnostic Systems ACTIVE Free

Testosterone RIA (13393)

Analyte: Thyroid Stimulating Hormone

(TSH) (Neonatal) (6107)

Test System, Assay, Examination:

Diagnostic Products Corp. Coat-A-Count

IRMA (13109)

Analyte: Thyroid Stimulating Hormone—

High Sens. (TSH–HS) (6108)

Test System, Assay, Examination:

Johnson & Johnson CDL Amerlite Analyzer

(31016)

Analyte: Thyroxine (T4) (6109)

Test System, Assay, Examination:

Biomerica T4 Microwell EIA (07635)

Diagnostic Systems DSL–3200 ACTIVE

Thyroxine RIA (13406)

Analyte: Thyroxine (T4), Neonatal (6123)

Test System, Assay, Examination:

Wallac Oy DELFIA Neonatal Thyroxine

(T4) Kit (70168)

Analyte: Thyroxine Binding Globulin (TBG)

(6110)

Test System, Assay, Examination:

Johnson & Johnson CDL Amerlite Analyzer

(31016)

Analyte: Thyroxine, Free (FT4) (6111)

Test System, Assay, Examination:

Johnson & Johnson CDL Amerlite Analyzer

(31016)

Analyte: Triiodothyronine (T3) (6119)

Test System, Assay, Examination:

Biomerica T3 Microwell EIA (07774)

Diagnostic Systems DSL 3100 ACTIVE T3

Coated-Tube RIA (13413)

Analyte: Triiodothyronine, Free (FT3) (6121)

Test System, Assay, Examination:

Roche Cobas Core Free T3 EIA (manual)

(55135)

Speciality/Subspeciality: General

Chemistry

Analyte: 1–Methylhistidine (0107)

Test System, Assay, Examination:

Waters Pico-Tag Amino Acid Analysis

System (70171)

Analyte: 3–Methylhistidine (0108)

Test System, Assay, Examination:

Waters Pico-Tag Amino Acid Analysis

System (70171)

Analyte: Acid Phosphatase (0407)

Test System, Assay, Examination:

Horizon Acid Phosphatase Manual

Procedure (25222)

Analyte: Alanine (0511)

Test System, Assay, Examination:

Waters Pico-Tag Amino Acid Analysis

System (70171)

Analyte: Alanine Aminotransferase (ALT)

(SGPT) (0404)

Test System, Assay, Examination:

HiChem Alanine Transaminase (ALT)

Reagent Kit (manual) (25227)

Horizon ALT (SGPT) Manual Procedure

(25216)

MeDiTech Alanine Aminotransferase

(ALT) (manual) (40216)

Ortho ALT Microwell Test System

(manual) (46167)

Analyte: Albumin (0414)

Test System, Assay, Examination:

Horizon Serum Albumin Manual

Procedure (25204)

Analyte: Alkaline Phosphatase (ALP) (0416)

Test System, Assay, Examination:

Horizon Alkaline Phosphatase (pNPP Rate)

Manual Procedure (25205)

MeDiTech Alkaline Phosphatase (ALP)

(manual) (40240)

Analyte: Alkaline Phosphatase Bone Specific

(BAP) (0518)

Test System, Assay, Examination:

Metra Biosystems Alkphase-B (40227)

Analyte: Alpha-Amino-n-butyric Acid (0512)

Test System, Assay, Examination:

Waters Pico-Tag Amino Acid Analysis

System (70171)

Analyte: Alpha-Hydroxybutyrate

Dehydrogenase (HBDH) (0419)

Test System, Assay, Examination:

TECO Diagnostics HBDH Reagent Set

(manual) (61152)

Analyte: Ammonia, Plasma/Serum (0427)

Test System, Assay, Examination:

Boehringer Mannheim Ammonia (manual)

(07766)

Analyte: Amylase (0429)

Test System, Assay, Examination:

Horizon Amylase Manual Procedure

(25207)

Analyte: Anserine (0514)

Test System, Assay, Examination:

Waters Pico-Tag Amino Acid Analysis

System (70171)

Analyte: Apolipoprotein A1 (0462)

Test System, Assay, Examination:

Horizon Apolipoprotein A–1 (APO A–1)

Manual Procedure (25221)

Randox Laboratories Test Kit (manual)

(55106)

Analyte: Apolipoprotein B (0457)

Test System, Assay, Examination:

Horizon Apolipoprotein B (APO B) Manual

Procedure (25220)

Randox Laboratories Test Kit (manual)

(55106)

Analyte: Arginine (0515)

Test System, Assay, Examination:

Waters Pico-Tag Amino Acid Analysis

System (70171)

Analyte: Asparagine (0509)

Test System, Assay, Examination:

Waters Pico-Tag Amino Acid Analysis

System (70171)

Analyte: Aspartate Aminotransferase (AST)

(SGOT) (0405)

Test System, Assay, Examination:

HiChem Aspartate Transaminase (AST)

(manual) (25234)

Horizon AST (SGOT) Manual Procedure

(25215)

MeDiTech Aspartate Aminotranspherase

(AST) (manual)) (40241)

Analyte: Beta-Alanine (0732)

Test System, Assay, Examination:

Waters Pico-Tag Amino Acid Analysis

System (70171)

Analyte: Bilirubin, Total (0706)

Test System, Assay, Examination:

Horizon Total Bilirubin Manual Procedure

(25199)

Analyte: Calcium, Total (1005)

Test System, Assay, Examination:

Horizon Calcium (Liquid) Manual

Procedure (25208)

Synermed Calcium (manual) (58375)

Analyte: Carbon Dioxide, Total (CO2) (1003)

Test System, Assay, Examination:

Randox Laboratories CO2 (TOTAL)

(manual) (55201)

TECO Diagnostics Carbon Dioxide

(manual) (61150)

TRACE Scientific CO2–DST (manual)

(61212)

Analyte: Cerebrospinal Fluid (CSF) Protein

(1014)

Test System, Assay, Examination:

Randox Laboratories Test Kit (manual)

(55106)

Analyte: Chloride (1018)

Test System, Assay, Examination:

Horizon Chloride Manual Procedure

(25209)

Analyte: Cholesterol (1020)

Test System, Assay, Examination:

Horizon Cholesterol Manual Procedure

(25210)

Analyte: Citrulline (1105)

Test System, Assay, Examination:

Waters Pico-Tag Amino Acid Analysis

System (70171)

Analyte: Creatine Kinase (CK) (1034)

Test System, Assay, Examination:

Horizon Creatine Kinase Manual Procedure

(25211)

MeDiTech Creatine Kinase (CK) (manual)

(40220)

Analyte: Creatine Kinase MB Fraction

(CKMB) (1002)

Test System, Assay, Examination:

Horizon Creatine Kinase MB Manual

Procedure (25203)

Analyte: Creatinine (1035)

Test System, Assay, Examination:

Chimera CR Perfect Urine Creatinine

(manual) (10295)

Horizon Creatinine Manual Procedure

(25206)

Analyte: Ferritin (1902)

Test System, Assay, Examination:
35756 Federal Register / Vol. 61, No. 131 / Monday, July 8, 1996 / Notices

United Biotech UBI MAGIWEL Ferritin

Quantitative (64032)

Analyte: Folate, Red Blood Cell (RBC Folate)

(1930)

Test System, Assay, Examination:

Technicon Immuno 1 (manual

calculations) (61230)

Analyte: Galactose, Total (2223)

Test System, Assay, Examination:

ICN ImmuChem Galactose Microwell

Enzyme Assay (28390)

Isolab Fluoroscan II Neonatal Chemistry

System (28367)

Analyte: Galactose-1–Phosphate Uridyl

Transferase (2215)

Test System, Assay, Examination:

Isolab Fluoroscan II Neonatal Chemistry

System (28367)

Analyte: Gamma Glutamyl Transferase

(GGT) (2201)

Test System, Assay, Examination:

Diagnostic Chemicals GGT Assay Kit

(13395)

HiChem Gamma-GT Reagent Kit (manual)

(25182)

Horizon Gamma Glutamyl Transpeptidase

Manual Procedure (25200)

Analyte: Glucose (2203)

Test System, Assay, Examination:

HiChem Glucose/HK Reagent Kit (manual)

(25235)

Horizon Glucose (Hexokinase) Manual

Procedure (25219)

Horizon Glucose (Oxidase) Manual

Procedure (25218)

Analyte: Glutamine (2218)

Test System, Assay, Examination:

Waters Pico-Tag Amino Acid Analysis

System (70171)

Analyte: Glycated Hemoglobin, Total (2221)

Test System, Assay, Examination:

Horizon Glycohemoglobin Manual

Procedure (25201)

Analyte: Glycine (2219)

Test System, Assay, Examination:

Waters Pico-Tag Amino Acid Analysis

System (70171)

Analyte: Glycosylated Hemoglobin (Hgb

A1C) (2204)

Test System, Assay, Examination:

Bio-Rad MDMS/CDMS (07778)

Analyte: HDL Cholesterol (2550)

Test System, Assay, Examination:

Beckman Synchron CX 4 Delta (07762)

Beckman Synchron CX 5 Delta (07763)

Beckman Synchron CX 7 Delta (07764)

Boehringer Mannheim Hitachi 917 (07765)

Horizon HDL Cholesterol Manual

Procedure (25226)

Sigma Diagnostics HDL ISOSPIN (manual)

(58388)

Analyte: Histidine (2563)

Test System, Assay, Examination:

Waters Pico-Tag Amino Acid Analysis

System (70171)

Analyte: Human Hemoglobin in Feces (2565)

Test System, Assay, Examination:

SmithKline HemeSelect (58403)

Analyte: Hydroxyproline (2560)

Test System, Assay, Examination:

Waters Pico-Tag Amino Acid Analysis

System (70171)

Analyte: Iron (2814)

Test System, Assay, Examination:

Horizon Iron/IBC Manual Procedure

(25224)

Analyte: Iron Binding Capacity (Post

Saturation/Separation) (2815)

Test System, Assay, Examination:

Beckman Synchron CX 4 Delta (07762)

Beckman Synchron CX 5 Delta (07763)

Beckman Synchron CX 7 Delta (07764)

Boehringer Mannheim Hitachi 917 (07765)

Johnson & Johnson CDI Ektachem 250

(31019)

Johnson & Johnson CDI Ektachem 400

(31020)

Johnson & Johnson CDI Ektachem 500

(31021)

Johnson & Johnson CDI Ektachem 550 XRC

(31022)

Johnson & Johnson CDI Ektachem 700

(31023)

Johnson & Johnson CDI Ektachem 700

Analyzer C Series (31024)

Johnson & Johnson CDI Ektachem 700 XR

(31026)

Johnson & Johnson CDI Ektachem 750 XRC

(31027)

Johnson & Johnson CDI Ektachem 950 IRC

(31028)

Analyte: Iron Binding Capacity, Unsat.

(UIBC) no pretreat. (2823)

Test System, Assay, Examination:

Horizon Iron/IBC Manual Procedure

(25224)

Reagents Applications RAICHEM Test Kit

(manual) (55075)

Analyte: Isoleucine (2833)

Test System, Assay, Examination:

Waters Pico-Tag Amino Acid Analysis

System (70171)

Analyte: LDL Cholesterol (3748)

Test System, Assay, Examination:

Abbott Vision (Genzyme immunosep tube/

HDL channel) (04615)

DuPont Dimension (Genzyme immunosep

tube/HDL channel) (13379)

DuPont Dimension AR (Genzyme

immunosep tube/HDL channel) (13380)

Johnson & Johnson CDI Ektachem 250

(Genzyme tube/chol slid) (31036)

Johnson & Johnson CDI Ektachem 500

(Genzyme tube/chol slid) (31043)

Johnson & Johnson CDI Ektachem 700

(Genzyme tube/Chol slid) (31048)

Johnson & Johnson CDI Ektachem DT 60

(Genzyme tube/HDLslid) (31058)

Kodak Ektachem 250 (Genzyme

immunosep tube/Choles. slide) (34089)

Kodak Ektachem 500 (Genzyme

immunosep tube/Choles. slide) (34090)

Kodak Ektachem 700 (Genzyme

immunosep tube/Choles. slide) (34091)

Kodak Ektachem DT 60 (Genzyme

immunosep tube/HDL slide) (34092)

Technicon Chem 1 (Genzyme immunosep

tube/HDL channel) (61194)

Analyte: Lactate Dehydrogenase (LDH)

(3701)

Test System, Assay, Examination:

Horizon Lactate Dehydrogenase (LDH)

Manual Procedure (25217)

MeDiTech Lactate Dehydrogenase (LD)

(manual) (40217)

Analyte: Leucine (3749)

Test System, Assay, Examination:

Waters Pico-Tag Amino Acid Analysis

System (70171)

Analyte: Lysine (3750)

Test System, Assay, Examination:

Waters Pico-Tag Amino Acid Analysis

System (70171)

Analyte: Methionine (4031)

Test System, Assay, Examination:

Waters Pico-Tag Amino Acid Analysis

System (70171)

Analyte: Microalbumin (4019)

Test System, Assay, Examination:

ALPCO ORGenTec Micro-Albumin PIN

Assay (04663)

Wako Micro-Albumin B (manual) (70173)

Analyte: Mucopolysaccharides, Urinary

(4038)

Test System, Assay, Examination:

Glyco FACE Qualitative Urinary

Carbohydrate Analysis Kit (22181)

Analyte: Oligosaccharides, Urinary (4607)

Test System, Assay, Examination:

Glyco FACE Qualitative Urinary

Carbohydrate Analysis Kit (22181)

Analyte: Phenylalanine (4942)

Test System, Assay, Examination:

Isolab Fluoroscan II Neonatal Chemistry

System (28367)

Waters Pico-Tag Amino Acid Analysis

System (70171)

Analyte: Phosphorus (4906)

Test System, Assay, Examination:

Horizon Inorganic Phosphorus Manual

Procedure (25202)

Analyte: Protein Fractions (4920)

Test System, Assay, Examination:

Sebia Hydragel Protein Kit (manual)

(58367)

Analyte: Protein, Total (4921)

Test System, Assay, Examination:

Horizon Total Protein Manual Procedure

(25214)

Analyte: Protein, Total (Urine) (4972)

Test System, Assay, Examination:

Randox Laboratories Test Kit (manual)

(55106)

Analyte: Taurine (6141)

Test System, Assay, Examination:

Waters Pico-Tag Amino Acid Analysis

System (70171)

Analyte: Thyroglobulin (6124)

Test System, Assay, Examination:
Federal Register / Vol. 61, No. 131 / Monday, July 8, 1996 / Notices 35757

ALPCO ORGenTec PIA Thyroglobulin EIA

(04616)

Analyte: Triglyceride (6118)

Test System, Assay, Examination:

Horizon Triglyceride (INT) Manual

Procedure (25223)

MeDiTech Triglycerides (Glycerol Blk)

(manual) (40218)

Analyte: Tyrosine (6143)

Test System, Assay, Examination:

Waters Pico-Tag Amino Acid Analysis

System (70171)

Analyte: Urea (BUN) (6403)

Test System, Assay, Examination:

HiChem BUN/Urea Reagent Kit (manual)

(25259)

Horizon Blood Urea Nitrogen (BUN)

Manual Procedure (25212)

MeDiTech Blood Urea Nitrogen (manual)

(40219)

Randox Laboratories Test Kit (manual)

(55106)

Analyte: Uric Acid (6404)

Test System, Assay, Examination:

Horizon Uric Acid Manual Procedure

(25213)

Analyte: Valine (6717)

Test System, Assay, Examination:

Waters Pico-Tag Amino Acid Analysis

System (70171)

Specialty/Subspecialty: General

Immunology

Analyte: Allergen Specific IgE (0417)

Test System, Assay, Examination:

Hycor HY–TEC Specific IgE EIA Assay

(25175)

Hycor Specific IgE EIA (25230)

Analyte: Anti-Cardiolipin Antibodies (0434)

Test System, Assay, Examination:

INOVA Diagnostics QUANTA Lite ACA

Screen (HRP) (28406)

INOVA Diagnostics QUANTA Lite IgA

ACA (HRP) (28407)

INOVA Diagnostics QUANTA Lite IgG

ACA (HRP) (28403)

INOVA Diagnostics QUANTA Lite IgM

ACA (28386)

Immco Diagnostics Anti-Cardiolipin IgA

Antibody (ACA) Test (28329)

Immco Diagnostics Anti-Cardiolipin IgG

Antibody (ACA) Test (28328)

Immco Diagnostics Anti-Cardiolipin IgM

Antibody (ACA) Test (28327)

Immuno Probe Cardiolipin A EIA (28389)

Immuno Probe Cardiolipin G EIA (28437)

Immuno Probe Cardiolipin G,M,A EIA

(28405)

Immuno Probe Cardiolipin IgG,M,A EIA

Test Kit (28405)

Immuno Probe Cardiolipin M EIA (28388)

MarDx Cardiolipin IgA EIA (40247)

MarDx Cardiolipin IgG EIA (40245)

MarDx Cardiolipin IgG,M,A EIA (40244)

MarDx Cardiolipin IgM EIA (40246)

elias usa Varelisa Cardiolipin Abs Screen

(16122)

Analyte: Anti-Centromere Antibodies (0487)

Test System, Assay, Examination:

elias usa Varelisa ANA Profile (16110)

Analyte: Anti-DNA Antibodies (0435)

Test System, Assay, Examination:

ALPCO ORGenTec Anti-dsDNA Elisa

Assay (04649)

ALPCO ORGenTec Anti-dsDNA Pin

Immuno Assay (04623)

INOVA Diagnostics QUANTA Lite ssDNA

SemiQuant. ELISA (28436)

MarDx Anti-dsDNA (Immunoglobulin) EIA

(40253)

elias usa Varelisa Combined DNA

Antibodies (16107)

elias usa Varelisa dsDNA Antibodies

(FARR version) (16100)

Analyte: Anti-ENA Antibodies (0507)

Test System, Assay, Examination:

ALPCO ORGenTec ENAScreen (SS–A,SS–

B,Sm,RNP/Sm,Scl-70,Jo1) (04650)

ALPCO ORGenTec ENAscreen PIN

Immuno Assay (04656)

Helix Diagnostics ENA+Screen

(RNP,Sm,SS–A,SS–B,Scl-70,Jo-1) (25241)

Hemagen ENA Screen 4 Kit (RNP, Sm, SS–

A, SS–B) (25228)

Hemagen ENA Screen 6 Kit (RNP, Sm, SS–

A, SS–B, Scl-70,Jo-1) (25229)

MarDx ENA EIA Test Kit (40212)

Analyte: Anti-Glomerular Basement

Membrane (GBM) Antibodies (0524)

Test System, Assay, Examination:

Scimedx GMB Antibody (computer

calculations) (58408)

Scimedx GMB Antibody (manual

calculations) (58409)

Analyte: Anti-Histone Antibodies (0437)

Test System, Assay, Examination:

TheraTest Laboratories EL–ANA Profiles

Test (61018)

elias usa Varelisa Histone Antibodies

(qualitative) (16106)

elias usa Varelisa Histone Antibodies

(semi-quantitative) (16105)

Analyte: Anti-Jo-1 (0438)

Test System, Assay, Examination:

ALPCO ORGenTec Anti-JO–1 PIN Immuno

Assay (04653)

Helix Diagnostics Anti-Jo–1 EIA Antibody

Test (25231)

elias usa Varelisa ANA Profile (16110)

Analyte: Anti-Mitochondrial Antibodies

(AMTA) (0439)

Test System, Assay, Examination:

MarDx Mitochondria EIA Test Kit (40211)

Analyte: Anti-Myeloperoxidase (MPO)

Antibodies (0505)

Test System, Assay, Examination:

INOVA Diagnostics QUANTA Lite MPO

ELISA (28439)

Scimedx MPO Antibody (auto reader w/

data reduction) (58405)

Scimedx MPO Antibody (manual) (58404)

elias usa Varelisa MPO–ANCA EIA

(qualitative) (16130)

elias usa Varelisa MPO–ANCA EIA (semiquantitative) (16129)

Analyte: Anti-Neutrophil Cytoplasm

Antibodies (0440)

Test System, Assay, Examination:

Scimedx Anti-PR3 Antibody EIA

(computer calculations) (58386)

Scimedx Anti-PR3 Antibody EIA (manual

calculations) (58385)

elias usa Varelisa PR3–ANCA EIA

(qualitative) (16124)

elias usa Varelisa PR3–ANCA EIA (semiquantitative) (16123)

Analyte: Anti-Nuclear Antibodies (ANA)

(0441)

Test System, Assay, Examination:

Immuno Concepts HEp-2000 Colorzyme

ANA–Ro Test System (28396)

Roche Image Titer (RIAS) Antinuclear

Antibody (ANA) Kit (55199)

TheraTest Laboratories EL-ANAscr (61220)

elias usa Varelisa ANA-Screen (4) (16111)

Analyte: Anti-Parietal Cell Antibodies (0442)

Test System, Assay, Examination:

elias usa Varelisa Parietal Cell Abs

(qualitative) (16109)

elias usa Varelisa Parietal Cell Abs (semiquantitative) (16108)

Analyte: Anti-Phosphatidylserine Antibodies

(0521)

Test System, Assay, Examination:

Reaads Anti-Phosphatidylserine SemiQuantitative Test Kit (55186)

Analyte: Anti-RNP-Sm Antibodies (0502)

Test System, Assay, Examination:

ALPCO ORGenTec Anti-RNP/Sm Pin

Immuno Assay (04647)

Hemagen RNP-Sm ENA Kit (qualitative)

(25189)

Hemagen RNP-Sm ENA Kit (semiquantitative) (25194)

elias usa Varelisa ANA Profile (16110)

Analyte: Anti-SS-A/Ro (0446)

Test System, Assay, Examination:

ALPCO ORGenTec Anti-SS-A(Ro) PIN

Immuno Assay (04651)

elias usa Varelisa ANA Profile (16110)

Analyte: Anti-SS-B/La (0447)

Test System, Assay, Examination:

ALPCO ORGenTec Anti-SS-B(La) Pin

Immuno Assay (04648)

elias usa Varelisa ANA Profile (16110)

Analyte: Anti-Scl-70 (0448)

Test System, Assay, Examination:

ALPCO ORGenTec Anti-Scl 70 PIN

Immuno Assay (04652)

Helix Diagnostics Anti-Scl-70 EIA

Antibody Test (25232)

TheraTest Laboratories EL-ANA Profiles

Test (61018)

Analyte: Anti-Serine Protease 3 (PR3)

Antibodies (0522)

Test System, Assay, Examination:

INOVA Diagnostics QUANTA Lite PR3

ELISA (28440)

Analyte: Anti-Sm (Smith) (0450)

Test System, Assay, Examination:

ALPCO ORGenTec Anti-Sm(Smith) Pin

Immuno Assay (04646)

elias usa Varelisa ANA Profile (16110)

Analyte: Anti-Thyroglobulin Antibodies

(0453)

Test System, Assay, Examination:
35758 Federal Register / Vol. 61, No. 131 / Monday, July 8, 1996 / Notices

ALPCO ORGenTec Anti-TG Elisa (04621)

ALPCO ORGenTec Anti-TG PIA (04618)

ALPCO ORGenTec Anti-TG/TPO PIA

Combikit (04617)

Bayer Serodia-ATG (07695)

Fujirebio Serodia-ATG (19024)

MarDx Thyroglobulin EIA Test Kit (40235)

Sheild Diagnostics DIASTAT Anti-Tg Kit

(qualitative) (58373)

Sheild Diagnostics DIASTAT Anti-Tg Kit

(quantitative) (58372)

Analyte: Anti-Thyroid Microsomal

Antibodies (AMA) (0455)

Test System, Assay, Examination:

Cogent Diagnostics AUTOSTAT II

Autoantibody Test Kit (10267)

MarDx Microsomal EIA (40242)

MarDx Microsomal EIA Test Kit (40242)

Analyte: Anti-Trypanosoma Cruzi

Antibodies (0503)

Test System, Assay, Examination:

Hemagen Chagas’ Kit (25159)

Analyte: Anti-U1-snRNP Antibodies (0501)

Test System, Assay, Examination:

elias usa Varelisa ANA Profile (16110)

Analyte: B1 positive Lymphocytes (0735)

Test System, Assay, Examination:

Coulter EPICS Profile (10329)

Coulter EPICS Profile II (10219)

Coulter EPICS XL (10330)

Coulter EPICS XL-MCL (10331)

Analyte: B4 positive Lymphocytes (0736)

Test System, Assay, Examination:

Coulter EPICS Profile (10329)

Coulter EPICS Profile II (10219)

Coulter EPICS XL (10330)

Coulter EPICS XL-MCL (10331)

Analyte: Beta-2 Microglobulin (0703)

Test System, Assay, Examination:

The Binding Site B2 Microglobulin RID Kit

(61233)

Analyte: C-Reactive Protein (CRP) (1001)

Test System, Assay, Examination:

Hemagen CRP 150 EIA (25256)

Analyte: C1–Esterase Inhibitor (C1INH)

(1051)

Test System, Assay, Examination:

Kent Radial Immunodiffusion Test (34010)

Analyte: CD3 (IgG1) Positive Lymphocytes

(1111)

Test System, Assay, Examination:

Coulter EPICS Profile (10329)

Coulter EPICS Profile II (10219)

Coulter EPICS XL (10330)

Coulter EPICS XL-MCL (10331)

Analyte: CD3 (IgG1)/B4 Positive

Lymphocytes (1112)

Test System, Assay, Examination:

Coulter EPICS Profile (10329)

Coulter EPICS Profile II (10219)

Coulter EPICS XL (10330)

Coulter EPICS XL-MCL (10331)

Analyte: CD3 (IgG1)/T4 Positive

Lymphocytes (1113)

Test System, Assay, Examination:

Coulter EPICS Profile (10329)

Coulter EPICS Profile II (10219)

Coulter EPICS XL (10330)

Coulter EPICS XL-MCL (10331)

Analyte: CD3 (IgG1)/T8 Positive

Lymphocytes (1114)

Test System, Assay, Examination:

Coulter EPICS Profile (10329)

Coulter EPICS Profile II (10219)

Coulter EPICS XL (10330)

Coulter EPICS XL-MCL (10331)

Analyte: CD3/CD19/CD45 Positive

Lymphocytes (1120)

Test System, Assay, Examination:

Becton Dickinson FACScan Flow

Cytometer (07497)

Becton Dickinson FACSort Flow Cytometer

(07637)

Analyte: CD3/CD4/CD45 Positive

Lymphocytes (1121)

Test System, Assay, Examination:

Becton Dickinson FACScan Flow

Cytometer (07497)

Becton Dickinson FACSort Flow Cytometer

(07637)

Analyte: CD3/T4/T8 Positive Lymphocytes

(1122)

Test System, Assay, Examination:

Coulter EPICS Profile (10329)

Coulter EPICS Profile II (10219)

Coulter EPICS XL (10330)

Coulter EPICS XL-MCL (10331)

Coulter Epics Flow Cytometer (10246)

Analyte: CD4 Protein (1124)

Test System, Assay, Examination:

T Cell Diagnostics TRAx CD4 Test Kit

(61195)

Analyte: Complement C1q (1064)

Test System, Assay, Examination:

Kent Radial Immunodiffusion Test (34010)

Analyte: Complement C5 (1031)

Test System, Assay, Examination:

The Binding Site Human Complement C5

RID (61206)

Analyte: Complement, Total (1046)

Test System, Assay, Examination:

Incstar Complement Activation EIA Test

System (CAE) (28404)

Analyte: Cytomegalovirus Antibodies (1039)

Test System, Assay, Examination:

Centocor CAPTIA CMV-M (10306)

Centocor CAPTIA CMV-TA (EIA) (10300)

Quest International SeraQuest CMV IgG

(52030)

Analyte: Epstein-Barr Virus Antibodies

(1603)

Test System, Assay, Examination:

Granbio Inc. EBNA IgG EIA Kit (22180)

Gull Laboratories EBNA IgG (Quantitative)

ELISA Test (22168)

Gull Laboratories EBV–EA(D) IgG ELISA

(qualitative) (22172)

Gull Laboratories EBV–EA(D) IgG ELISA

(quantitative) (22169)

Immuno Probe EBNA IgG ELISA (28411)

Incstar EBNA IgG ELISA (28372)

Incstar EBV VCA IgG ELISA (28371)

Incstar EBV VCA IgM ELISA (28373)

MRL Diagnostics EBNA RIFA Antibody

Test (40202)

Zeus EBNA IgG ELISA Test System (79048)

Zeus EBV–VCA IgM ELISA Test System

(79046)

Analyte: Helicobacter Pylori Antibodies

(2513)

Test System, Assay, Examination:

Enteric Products HM–CAP EIA Test

(16076)

Analyte: Hepatitis B Surface Antigen

(HBsAg) (2524)

Test System, Assay, Examination:

Abbott IMX HBsAg Confirmatory (04658)

Analyte: Immunoglobulins IgA (2803)

Test System, Assay, Examination:

Randox Laboratories IgA (manual) (55203)

Analyte: Immunoglobulins IgE (2805)

Test System, Assay, Examination:

Hycor HY–TEC Total IgE EIA Assay

(25174)

Analyte: Immunoglobulins IgG (2806)

Test System, Assay, Examination:

Randox Laboratories IgG (manual) (55205)

Analyte: Immunoglobulins IgM (2808)

Test System, Assay, Examination:

Randox Laboratories IgM (manual) (55204)

Analyte: Leukocyte Common Antigen (LCA)

(3756)

Test System, Assay, Examination:

BioTek Sol’n TechMate/ChemMate Spc.

Stain LCA–CD45 (tissue) (07538)

Analyte: MY4 Positive Lymphocytes (4033)

Test System, Assay, Examination:

Coulter EPICS Profile (10329)

Coulter EPICS Profile II (10219)

Coulter EPICS XL (10330)

Coulter EPICS XL–MCL (10331)

Analyte: Mo2 Positive Lymphocytes (4034)

Test System, Assay, Examination:

Coulter EPICS Profile (10329)

Coulter EPICS Profile II (10219)

Coulter EPICS XL (10330)

Coulter EPICS XL–MCL (10331)

Analyte: Rheumatoid Factor (RF) (5508)

Test System, Assay, Examination:

TheraTest Laboratories EL–RF/3 (IgM–IgG–

IgA) Kit (61157)

Analyte: Rubella Antibodies (5510)

Test System, Assay, Examination:

Centocor CAPTIA Rubella–G (10305)

Centocor CAPTIA Rubella–M (10304)

Analyte: T1 Positive Lymphocytes (6157)

Test System, Assay, Examination:

Coulter EPICS Profile (10329)

Coulter EPICS Profile II (10219)

Coulter EPICS XL (10330)

Coulter EPICS XL–MCL (10331)

Analyte: T11 Positive Lymphocytes (6146)

Test System, Assay, Examination:

Coulter EPICS Profile (10329)

Coulter EPICS Profile II (10219)

Coulter EPICS XL (10330)

Coulter EPICS XL–MCL (10331)
Federal Register / Vol. 61, No. 131 / Monday, July 8, 1996 / Notices 35759

Analyte: T11/B1 Positive Lymphocytes

(6147)

Test System, Assay, Examination:

Coulter EPICS Profile (10329)

Coulter EPICS Profile II (10219)

Coulter EPICS XL (10330)

Coulter EPICS XL–MCL (10331)

Analyte: T11/B4 Positive Lymphocytes

(6148)

Test System, Assay, Examination:

Coulter EPICS Profile (10329)

Coulter EPICS Profile II (10219)

Coulter EPICS XL (10330)

Coulter EPICS XL–MCL (10331)

Analyte: T3 Positive Lymphocytes (6149)

Test System, Assay, Examination:

Coulter EPICS Profile (10329)

Coulter EPICS Profile II (10219)

Coulter EPICS XL (10330)

Coulter EPICS XL–MCL (10331)

Analyte: T4 Positive Lymphocytes (6150)

Test System, Assay, Examination:

Coulter EPICS Profile (10329)

Coulter EPICS Profile II (10219)

Coulter EPICS XL (10330)

Coulter EPICS XL–MCL (10331)

Analyte: T4/T8 Positive Lymphocytes (6151)

Test System, Assay, Examination:

Coulter EPICS Profile (10329)

Coulter EPICS Profile II (10219)

Coulter EPICS XL (10330)

Coulter EPICS XL–MCL (10331)

Analyte: T8 Positive Lymphocytes (6152)

Test System, Assay, Examination:

Coulter EPICS Profile (10329)

Coulter EPICS Profile II (10219)

Coulter EPICS XL (10330)

Coulter EPICS XL–MCL (10331)

Analyte: Thyroid Peroxidase Autoantibodies

(TPO) (6135)

Test System, Assay, Examination:

ALPCO ORGenTec Anti-TG/TPO PIA

Combikit (04617)

ALPCO ORGenTec Anti-TPO Elisa (04622)

ALPCO ORGenTec Anti-TPO PIA (04619)

Biomerica Anti-Thyroid Peroxidase (AntiTPO) ELISA (07728)

Shield Diagnostics DIASTAT Anti-TPO Kit

(qualitative) (58377)

Shield Diagnostics DIASTAT Anti-TPO Kit

(semi-quantitative) (58378)

Analyte: Toxoplasma Gondii Antibodies

(6113)

Test System, Assay, Examination:

BioWhittaker TOXOSTAT Test (07564)

Centocor CAPTIA Toxo-G (10308)

Centocor CAPTIA Toxo-M (10307)

Analyte: Treponema pallidum Antibodies

(Includes Reagin) (6115)

Test System, Assay, Examination:

ADI Visuwell Syphilis Antibody (04546)

BIOMIRA Diagnostics Visuwell Reagin II

(07688)

Centocor CAPTIA Syphilis-G (10310)

Centocor CAPTIA Syphilis-M (10309)

ANALYTE: Varicella-Zoster Virus

Antibodies (6704)

Test System, Assay, Examination:

Gull Laboratories VZV IgG ELISA Test

(22170)

Speciality/Subspeciality: Hematology

Analyte: Activated Partial Thromboplastin

Time (APTT) (0409)

Test System, Assay, Examination:

Behring Pathromtin SL APTT (manual)

(07777)

Ortho SynthASil APTT (manual) (46195)

Analyte: Alpha-2–Antiplasmin (0463)

Test System, Assay, Examination:

Medical Laboratory MLA Electra 1400C

(40208)

ANALYTE: Antithrombin III (ATIII) (0456)

Test System, Assay, Examination:

Helena Laboratories Chrom Z–AT (manual)

(25242)

Helena Laboratories PACKS–4 (25029)

Instrumentation Laboratory IL ACL Futura

System (28395)

Medical Laboratory MLA Electra 1400C

(40208)

Analyte: Coagulation Factors (1044)

Test System, Assay, Examination:

Behring Fibrintimer A (07516)

Bio/Data Microsample Coagulation

Analyzer, MCA 310 (07597)

Helena Laboratories Chrom Z-Factor VIII:C

(manual) (25239)

Helena Laboratories PACKS–4 (25029)

Medical Laboratory MLA Electra 1400C

(40208)

Pharmacia Hepar Chromogenix Coamatic

Factor VIII (49149)

Analyte: Coagulation Index, Modified Whole

Blood (1128)

Test System, Assay, Examination:

Haemoscope Thromboelastograph 3000S

(TEG 3000S) (25257)

Analyte: Coagulation Index, Modified/

Recalcified PRP/PPP (1129)

Test System, Assay, Examination:

Haemoscope Thromboelastograph 3000S

(TEG 3000S) (25257)

Analyte: Fibrin Split Products (Fibrin

Degradation) (1904)

Test System, Assay, Examination:

AGEN Dimertest Gold EIA (04580)

Analyte: Fibrinogen (1905)

Test System, Assay, Examination:

Bio/Data MCA 210 (von Clauss

Methodology) (07696)

Bio/Data MCA 310 (von Clauss

Methodology) (07697)

Analyte: Heparin (2518)

Test System, Assay, Examination:

American Bioproducts ROTACHROM

HBPM/LMWH (04583)

American Bioproducts ROTACHROM

Heparin (04584)

American Bioproducts STACHROM

Heparin Assay (04560)

American Bioproducts STACLOT Heparin

(manual) (04582)

Chromogenix COACUTE Heparin (manual)

(10313)

Analyte: Lupus Anticoagulants (3728)

Test System, Assay, Examination:

Becton Dickinson BBL Fibrometer

(Am.Diag.DDVtest/DVVconfrm) (07691)

Bio/Data MCA 210 (Am. Diagnostica

DVVtest/DVVconfirm) (07692)

Bio/Data MCA 310 (Am. Diagnostica

DVVtest/DVVconfirm) (07693)

Diagnostica Stago ST4 (Am.Diagnostica

DDVtest/DVVconfirm) (13405)

General Diagnostics Coag-A-Mate X2

(Am.Diag.DVVtest/confrm) (22179)

Instrumentation Laboratory IL ACL

300(Am.Diag.DVVtest/cfrm) (28412)

Instrumentation Laboratory IL ACL

300+(Am.Diag.DVVtst/cfrm) (28413)

Medical Laboratory MLA Electra 700

(Am.Diag.DVVtest/confrm) (40228)

Medical Laboratory MLA Electra 800

(Am.Diag.DVVtest/confrm) (40229)

Medical Laboratory MLA Electra

900C(Am.Diag.DVVtest/confrm) (40230)

Medical Laboratory MLA

Electra1000C(Am.Diag.DVVtest/confrm)

(40231)

Analyte: Plasminogen (4907)

Test System, Assay, Examination:

Helena Laboratories Chrom Z-PLG

(manual) (25240)

Helena Laboratories PACKS–4 (25029)

Medical Laboratory MLA Electra 1400C

(40208)

Analyte: Plasminogen Activator Inhibitor

(PAI) (4936)

Test System, Assay, Examination:

Medical Laboratory MLA Electra 1400C

(40208)

Analyte: Platelet Count (4908)

Test System, Assay, Examination:

Coulter Z1 (10325)

Analyte: Protein C (4929)

Test System, Assay, Examination:

Helena Laboratories Chrom Z-Protein C

(manual) (25237)

Helena Laboratories PACKS–4 (25029)

Medical Laboratory MLA Electra 1400C

(40208)

Analyte: Protein C Resistance (4973)

Test System, Assay, Examination:

Chromogenix COATEST APC Resistance

(manual) (10286)

Analyte: Protein S (4930)

Test System, Assay, Examination:

Diagnostica Stago ASSERACHROM Free

Protein S (13404)

Diagnostica Stago ASSERACHROM Total

Protein S (13403)

Analyte: Prothrombin Time (PT) (4922)

Test System, Assay, Examination:

Helena Laboratories Thromboplastin

Reagent-LI (manual) (25244)

Ortho RecombiPlasTin II (manual) (46149)

Pacific Hemostasis ThromboScreen

Thromboplastin-DS (manual) (49154)

Analyte: Red Blood Cell Count (Erythrocyte

Count) (RBC) (5502)

Test System, Assay, Examination:

Coulter Z1 (10325)
35760 Federal Register / Vol. 61, No. 131 / Monday, July 8, 1996 / Notices

Analyte: Reptilase Time (5521)

Test System, Assay, Examination:

Biopool Venom Time Reagent (manual)

(07737)

Analyte: Reticulocyte Count (5506)

Test System, Assay, Examination:

Becton Dickinson FACSCalibur Flow

Cytometer (07639)

Becton Dickinson FACSort Flow Cytometer

(07637)

Analyte: White Blood Cell Count (Leukocyte

Count) (WBC) (7002)

Test System, Assay, Examination:

Coulter Z1 (10325)

Analyte: White Blood Cell Differential (WBC

Diff) (7001)

Test System, Assay, Examination:

IRIS The White IRIS Leukocyte Differential

Analyzer (28408)

Analyte: von Willebrand Factor (6708)

Test System, Assay, Examination:

American Diagnostica Rellplate vWF EID

Kit (04662)

Speciality/Subspeciality:

Mycobacteriology

Analyte: Mycobacteria (4024)

Test System, Assay, Examination:

Becton Dickinson BACTEC 9000MB

(07746)

Analyte: Mycobacterium Avium (4008)

Test System, Assay, Examination:

Gen-Probe AccuProbe—M. avium specific

(including culture) (22129)

Analyte: Mycobacterium Avium Complex

(4009)

Test System, Assay, Examination:

DynaGen MycoAKT Kit for M. avium

Complex (inc. culture) (13383)

Gen-Probe AccuProbe—M. avium complex

(including culture) (22128)

Syngene Snap Culture ID Diagnostic Kit/M.

avium complex (58069)

Analyte: Mycobacterium Gordonae (4011)

Test System, Assay, Examination:

Gen-Probe AccuProbe—M. gordonae

(including culture) (22130)

Analyte: Mycobacterium Intracellulare

(4012)

Test System, Assay, Examination:

Gen-Probe AccuProbe—M. intracellulare

specific (inc cult) (22131)

Analyte: Mycobacterium Kansasii (4014)

Test System, Assay, Examination:

DynaGen MycoAKT Kit for M. kansasii

(including culture) (13384)

Gen-Probe AccuProbe—M. kansasii

(including culture) (22127)

Analyte: Mycobacterium Tuberculosis

Complex (4015)

Test System, Assay, Examination:

Becton Dickinson BACTEC TB System

(NAP Differentiat. Test) (07084)

Becton Dickinson BACTEC TB System

(Susceptibility Test) (07222)

DynaGen MycoAKT Kit for M. tuberculosis

Complex (inc. cult) (13385)

Gen-Probe AccuProbe—M. tuberculosis

complex (inc culture) (22132)

Syngene Snap Culture ID Diagnostic Kit/M.

tuberculosis cplx (58152)

Speciality/Subspeciality: Mycology

Analyte: Fungi—Fungal Elements Only

(1910)

Test System, Assay, Examination:

Remel Calcofluor White Stain Kit (55206)

Analyte: Yeast (7601)

Test System, Assay, Examination:

Remel Calcofluor White Stain Kit (55206)

Speciality/Subspeciality: Parasitology

Analyte: Acanthamoeba (0523)

Test System, Assay, Examination:

Remel Calcofluor White Stain Kit (55206)

Analyte: Cryptosporidium (1109)

Test System, Assay, Examination:

Alexon ProSpecT Giardia/Crypto.

Microplate (dirAg/spectro) (04655)

Alexon ProSpecT Giardia/Crypto.

Microplate (dirAg/visual) (04654)

Analyte: Entamoeba Histolytica (1631)

Test System, Assay, Examination:

TechLab Entamoeba Test

(spectrophotometer) (61169)

TechLab Entamoeba Test (visual) (61168)

Analyte: Giardia lamblia (2222)

Test System, Assay, Examination:

Alexon ProSpecT Giardia/Crypto.

Microplate (dirAg/spectro) (04655)

Alexon ProSpecT Giardia/Crypto.

Microplate (dirAg/visual) (04654)

TechLab CeLLabs Giardia-Cel IF Test

(61218)

Trend Scientific Giardia Direct Detection

RS Test (61204)

Analyte: Microsporidia (4039)

Test System, Assay, Examination:

Remel Calcofluor White Stain Kit (55206)

Analyte: Pneumocystis (4926)

Test System, Assay, Examination:

DAKO Quick Staining Kit for

Pneumocystis carinii (13376)

Remel Calcofluor White Stain Kit (55206)

Speciality/Subspeciality: Toxicology /

TDM

Analyte: Amphetamines (0428)

Test System, Assay, Examination:

Beckman Synchron CX 4 (CEDIA DAU/

manual curve) (07722)

Beckman Synchron CX 5 (CEDIA DAU/

manual curve) (07723)

Beckman Synchron CX 7 (CEDIA DAU/

manual curve) (07724)

Boehringer Mannheim Hitachi 704 (CEDIA

DAU/manual curve) (07718)

Boehringer Mannheim Hitachi 717 (CEDIA

DAU/manual curve) (07719)

Boehringer Mannheim Hitachi 747 (CEDIA

DAU/manual curve) (07720)

Boehringer Mannheim Hitachi 911 (CEDIA

DAU/manual curve) (07721)

Olympus AU 5000 (CEDIA DAU/manual

curve) (46212)

STC Diagnostics Amphetamines M-Plate

EIA (Sudormed Patch) (58374)

Analyte: Barbiturates (0701)

Test System, Assay, Examination:

Beckman Synchron CX 4 (CEDIA DAU/

manual curve) (07722)

Beckman Synchron CX 5 (CEDIA DAU/

manual curve) (07723)

Beckman Synchron CX 7 (CEDIA DAU/

manual curve) (07724)

Boehringer Mannheim Hitachi 704 (CEDIA

DAU/manual curve) (07718)

Boehringer Mannheim Hitachi 717 (CEDIA

DAU/manual curve) (07719)

Boehringer Mannheim Hitachi 747 (CEDIA

DAU/manual curve) (07720)

Boehringer Mannheim Hitachi 911 (CEDIA

DAU/manual curve) (07721)

Olympus AU 5000 (CEDIA DAU/manual

curve) (46212)

Analyte: Benzodiazepines (0702)

Test System, Assay, Examination:

Beckman Synchron CX 4 (CEDIA DAU/

manual curve) (07722)

Beckman Synchron CX 5 (CEDIA DAU/

manual curve) (07723)

Beckman Synchron CX 7 (CEDIA DAU/

manual curve) (07724)

Bio-Rad REMEDi HS-Urine

Benzodiazepine Assay (07744)

Boehringer Mannheim Hitachi 704 (CEDIA

DAU/manual curve) (07718)

Boehringer Mannheim Hitachi 717 (CEDIA

DAU/manual curve) (07719)

Boehringer Mannheim Hitachi 747 (CEDIA

DAU/manual curve) (07720)

Boehringer Mannheim Hitachi 911 (CEDIA

DAU/manual curve) (07721)

Olympus AU 5000 (CEDIA DAU/manual

curve) (46212)

Analyte: Cannabinoids (THC) (1009)

Test System, Assay, Examination:

Beckman Synchron CX 4 (CEDIA DAU/

manual curve) (07722)

Beckman Synchron CX 5 (CEDIA DAU/

manual curve) (07723)

Beckman Synchron CX 7 (CEDIA DAU/

manual curve) (07724)

Boehringer Mannheim Hitachi 704 (CEDIA

DAU/manual curve) (07718)

Boehringer Mannheim Hitachi 717 (CEDIA

DAU/manual curve) (07719)

Boehringer Mannheim Hitachi 747 (CEDIA

DAU/manual curve) (07720)

Boehringer Mannheim Hitachi 911 (CEDIA

DAU/manual curve) (07721)

Meco Industries MECTEST Cannabinoid

Radioimmunoassay (40234)

Olympus AU 5000 (CEDIA DAU/manual

curve) (46212)

Analyte: Cocaine Metabolites (1023)

Test System, Assay, Examination:

Beckman Synchron CX 4 (CEDIA DAU/

manual curve) (07722)

Beckman Synchron CX 5 (CEDIA DAU/

manual curve) (07723)

Beckman Synchron CX 7 (CEDIA DAU/

manual curve) (07724)

Boehringer Mannheim Hitachi 704 (CEDIA

DAU/manual curve) (07718)

Boehringer Mannheim Hitachi 717 (CEDIA

DAU/manual curve) (07719)

Boehringer Mannheim Hitachi 747 (CEDIA

DAU/manual curve) (07720)

Boehringer Mannheim Hitachi 911 (CEDIA

DAU/manual curve) (07721)
Federal Register / Vol. 61, No. 131 / Monday, July 8, 1996 / Notices 35761

Meco Industries MECTEST Cocaine

Radioimmunoassay (40232)

Olympus AU 5000 (CEDIA DAU/manual

curve) (46212)

STC Diagnostics Cocaine M-Plate EIA

(Sudormed Patch) (58379)

Analyte: Digoxin (1304)

Test System, Assay, Examination:

Johnson & Johnson CDL Amerlite Analyzer

(31016)

Analyte: Drugs of Abuse (1307)

Test System, Assay, Examination:

Bio-Rad REMEDi HS Drug Profiling System

(07604)

Analyte: Lysergic Acid Diethylamide (LSD)

(3715)

Test System, Assay, Examination:

Boehringer Mannheim Hitachi 911 (CEDIA

DAU/manual curve) (07721)

STC Diagnostics LSD Micro-Plate EIA

(58395)

Analyte: Methadone (4003)

Test System, Assay, Examination:

Boehringer Mannheim Hitachi 704 (CEDIA

DAU/manual curve) (07718)

Boehringer Mannheim Hitachi 717 (CEDIA

DAU/manual curve) (07719)

Boehringer Mannheim Hitachi 747 (CEDIA

DAU/manual curve) (07720)

Boehringer Mannheim Hitachi 911 (CEDIA

DAU/manual curve) (07721)

Boehringer Mannheim Hitachi 917 (CEDIA

DAU/manual curve) (07768)

Analyte: Methamphetamine/Amphetamine

(4036)

Test System, Assay, Examination:

Sigma SIA Methamphetamine/

Amphetamine (58103)

Analyte: Methamphetamines (4004)

Test System, Assay, Examination:

STC Diagnostics Methamphetamine MPlate EIA (Sudormed Patch) (58381)

Analyte: Opiates (4601)

Test System, Assay, Examination:

Beckman Synchron CX 4 (CEDIA DAU/

manual curve) (07722)

Beckman Synchron CX 5 (CEDIA DAU/

manual curve) (07723)

Beckman Synchron CX 7 (CEDIA DAU/

manual curve) (07724)

Boehringer Mannheim Hitachi 704 (CEDIA

DAU/manual curve) (07718)

Boehringer Mannheim Hitachi 717 (CEDIA

DAU/manual curve) (07719)

Boehringer Mannheim Hitachi 747 (CEDIA

DAU/manual curve) (07720)

Boehringer Mannheim Hitachi 911 (CEDIA

DAU/manual curve) (07721)

Meco Industries MECTEST Opiate

Radioimmunoassay (40233)

Olympus AU 5000 (CEDIA DAU/manual

curve) (46212)

STC Diagnostics Opiates M-Plate EIA

(Sudormed Patch) (58380)

Analyte: Phencyclidine (PCP) (4901)

Test System, Assay, Examination:

Beckman Synchron CX 4 (CEDIA DAU/

manual curve) (07722)

Beckman Synchron CX 5 (CEDIA DAU/

manual curve) (07723)

Beckman Synchron CX 7 (CEDIA DAU/

manual curve) (07724)

Boehringer Mannheim Hitachi 704 (CEDIA

DAU/manual curve) (07718)

Boehringer Mannheim Hitachi 717 (CEDIA

DAU/manual curve) (07719)

Boehringer Mannheim Hitachi 747 (CEDIA

DAU/manual curve) (07720)

Boehringer Mannheim Hitachi 911 (CEDIA

DAU/manual curve) (07721)

Olympus AU 5000 (CEDIA DAU/manual

curve) (46212)

STC Diagnostics PCP M-Plate EIA

(Sudormed Patch) (58406)

Analyte: Propoxyphene (4917)

Test System, Assay, Examination:

Beckman Synchron CX 4 (CEDIA DAU/

manual curve) (07722)

Beckman Synchron CX 5 (CEDIA DAU/

manual curve) (07723)

Beckman Synchron CX 7 (CEDIA DAU/

manual curve) (07724)

Boehringer Mannheim Hitachi 704 (CEDIA

DAU/manual curve) (07718)

Boehringer Mannheim Hitachi 717 (CEDIA

DAU/manual curve) (07719)

Boehringer Mannheim Hitachi 747 (CEDIA

DAU/manual curve) (07720)

Boehringer Mannheim Hitachi 911 (CEDIA

DAU/manual curve) (07721)

Speciality/Subspeciality: Virology

Analyte: Coxsackie A24 Virus (1098)

Test System, Assay, Examination:

Light Diag. MAb Coxsackie A24 Virus (inc.

culture) (37073)

Analyte: Coxsackie A9 Virus (1097)

Test System, Assay, Examination:

Light Diag. MAb Coxsackie A9 Virus (inc.

culture) (37072)

Analyte: Coxsackie B1 Virus (1099)

Test System, Assay, Examination:

Light Diag. MAb Coxsackie B Virus Blend

(inc. culture) (37087)

Light Diag. MAb Coxsackie B1 Virus (inc.

culture) (37074)

Analyte: Coxsackie B2 Virus (1100)

Test System, Assay, Examination:

Light Diag. MAb Coxsackie B Virus Blend

(inc. culture) (37087)

Light Diag. MAb Coxsackie B2 Virus (inc.

culture) (37075)

Analyte: Coxsackie B3 Virus (1101)

Test System, Assay, Examination:

Light Diag. MAb Coxsackie B Virus Blend

(inc. culture) (37087)

Light Diag. MAb Coxsackie B3 Virus (inc.

culture) (37076)

Analyte: Coxsackie B4 Virus (1102)

Test System, Assay, Examination:

Light Diag. MAb Coxsackie B Virus Blend

(inc. culture) (37087)

Light Diag. MAb Coxsackie B4 Virus (inc.

culture) (37077)

Analyte: Coxsackie B5 Virus (1103)

Test System, Assay, Examination:

Light Diag. MAb Coxsackie B Virus Blend

(inc. culture) (37087)

Light Diag. MAb Coxsackie B5 Virus (inc.

culture) (37078)

Analyte: Coxsackie B6 Virus (1104)

Test System, Assay, Examination:

Light Diag. MAb Coxsackie B Virus Blend

(inc. culture) (37087)

Light Diag. MAb Coxsackie B6 Virus (inc.

culture) (37079)

Analyte: Cytomegalovirus (1038)

Test System, Assay, Examination:

Biotest Diagnostics CMV Brite (direct

antigen) (07661)

Analyte: Enterovirus 70 (1625)

Test System, Assay, Examination:

Light Diag. MAb Enterovirus 70 (inc.

culture) (37086)

Light Diag. MAb Enterovirus Blend (inc.

culture) (37084)

Analyte: Enterovirus 71 (1626)

Test System, Assay, Examination:

Light Diag. MAb Enterovirus 71 (inc.

culture) (37088)

Light Diag. MAb Enterovirus Blend (inc.

culture) (37084)

Analyte: Herpes Simplex (2529)

Test System, Assay, Examination:

Diagnostic Hybrids ELVIS HSV Kit (inc.

cell culture) (13318)

Johnson & Johnson CDI SureCell (including

cell culture) (31064)

Meridian Premier HSV Plus (direct

antigen/spectro.) (40238)

Meridian Premier HSV Plus (direct

antigen/visual) (40239)

Meridian Premier HSV Plus (inc. cell cult./

spectro.) (40237)

Meridian Premier HSV Plus (inc. cell cult./

visual) (40236)

Analyte: Poliovirus 1 (4966)

Test System, Assay, Examination:

Light Diag. MAb Poliovirus 1 (inc. culture)

(37080)

Light Diag. MAb Poliovirus Blend (inc.

culture) (37083)

Analyte: Poliovirus 2 (4967)

Test System, Assay, Examination:

Light Diag. MAb Poliovirus 2 (inc. culture)

(37081)

Light Diag. MAb Poliovirus Blend (inc.

culture) (37083)

Analyte: Poliovirus 3 (4968)

Test System, Assay, Examination:

Light Diag. MAb Poliovirus 3 (inc. culture)

(37082)

Light Diag. MAb Poliovirus Blend (inc.

culture) (37083)

Analyte: Varicella-Zoster Viruses (6705)

Test System, Assay, Examination:

Light Diag. Varicella-zoster Virus Direct

IFA (direct Ag) (37104)

Light Diag. Varicella-zoster Virus Direct

IFA (inc. cult.) (37105)

Complexity: Waived

Speciality/Subspeciality: Bacteriology

Analyte: Helicobacter Pylori (2512)

Test System, Assay, Examination:

Serim PyloriTek Test Kit (58338)
35762 Federal Register / Vol. 61, No. 131 / Monday, July 8, 1996 / Notices

Analyte: Streptococcus, Group A (From

Throat Only) (5828)

Test System, Assay, Examination:

Quidel QuickVue In-Line One-Step Strep A

Test (25 test kit) (52036)

Speciality/Subspeciality: Endocrinology

Analyte: Ovulation Test (LH) by Visual Color

Comparison (9461)

Test System, Assay, Examination:

Quidel Conceive Ovulation Predictor

(52029)

Syntron Bioresearch BeSure OneStep

Ovulation Predictor Kit (58365)

Analyte: Urine HCG by Visual Color

Comparison Tests (9642)

Test System, Assay, Examination:

3C Diagnostics MIT One-Step Immediate

Pregnancy Test (01001)

AmeriTek One step dBest Dipstick (04661)

AmeriTek One step dBest Disk (04659)

AmeriTek One step dBest Midstream

(04660)

Applied Biotech SureStrip hCG Pregnancy

Test (04635)

Bionike A/Q Pregnancy Test (07636)

Boehringer Mannheim Accu-Stat hCG

(07710)

Excel Scientific OneStep Urine/Serum hCG

Preg Module Test (16133)

Horizon Diagnostics Pregna-Plus hCG

(25225)

Immunostics immuno hCG Detector

Pregnancy Test (28418)

Immunostics immuno hCG Detector Stix

(28417)

International Newtech Develop. MiniStrip

HCG ONESTEP (28394)

Johnson & Johnson CDI SureCell hCGUrine (31067)

Johnson & Johnson CDI SureCell hCGUrine/Serum (31066)

Medix Biotech CONTRAST hCG Urine/

Serum Test (40215)

Medix Biotech Rapid hCG (urine/serum)

(40224)

Mizuho USA Quick Checker hCG

Pregnancy Test (40207)

Quidel CAMEO Home Pregnancy Test

(52031)

Quidel CARDS Q.S. hCG (52032)

Quidel Concise Performance Plus hCG

(52033)

Sea-Band Pregnancy Test (58362)

Selfcare early Pregnancy test (test cassett)

(58401)

Selfcare early Pregnancy test (test stick)

(58400)

Simex Medical DiagnoStrip hCG (58397)

Syntron Platform OneStep Pregnancy Test

(58407)

Worldwide Medical First Check hCG

(cassette) (70181)

Worldwide Medical First Check hCG (test

stick) (70182)

Wyntek Diagnostics OSOM Pregnancy Test

for Home Use (70175)

Wyntek Diagnostics OSOM hCG-Combo

Test (70177)

Wyntek Diagnostics OSOM hCG-Urine Test

(70174)

Speciality/Subspeciality: General

Chemistry

Analyte: Body Fluids (Other Than Blood) pH

(0731)

Test System, Assay, Examination:

All Qualitative Color Comparison pH

Testing (04542)

Analyte: Cholesterol (1020)

Test System, Assay, Examination:

Boehringer Mannheim Accu-Chek

InstantPlus Cholesterol (07776)

ChemTrak AccuMeter (10165)

Cholestech L.D.X. (10170)

Johnson & Johnson ADVANCED CARE

Cholesterol Test (31014)

Analyte: Fecal Occult Blood (9191)

Test System, Assay, Examination:

Dipro Diagnostics Hemdetect (13308)

Immunostics hema screen (28419)

Analyte: Gastric Occult Blood (2211)

Test System, Assay, Examination:

SmithKline Gastroccult (58217)

Analyte: Glucose (2203)

Test System, Assay, Examination:

Cholestech L.D.X. (10170)

HemoCue B-Glucose System (25112)

Analyte: Glucose Monitoring Devices (FDA

Cleared/Home Use) (9221)

Test System, Assay, Examination:

Bayer GLUCOMETER ELITE Blood Glucose

Meter (07685)

Bayer GLUCOMETER ENCORE QA+ Blood

Glucose Meter (07689)

Chronimed Supreme Blood Glucose Meter

(10315)

Chronimed Supreme Blood Glucose Test

Strips (10316)

Johnson & Johnson Lifescan ONE TOUCH

II Bld Glucose Monitor (31017)

Johnson & Johnson Lifescan ONE TOUCH

II Glucose Test Strips (31018)

LifeScan ONE TOUCH Profile Complete

Diabetes Tracking Sys. (37101)

Lifescan SureStep Blood Glucose

Monitoring System (37090)

MediSense MediSense 2 Blood Glucose

Testing System (40214)

MediSense Precision QID Blood Glucose

Testing System (40213)

Analyte: HDL Cholesterol (2550)

Test System, Assay, Examination:

Cholestech L.D.X. (10170)

Analyte: Microalbumin (4019)

Test System, Assay, Examination:

Boehringer Mannheim Chemstrip Micral

(urine dipstick) (07717)

Analyte: Triglyceride (6118)

Test System, Assay, Examination:

Cholestech L.D.X. (10170)

Speciality/Subspeciality: Hematology

Analyte: Erythrocyte Sedimentation Rate,

Nonautomated Waived (9161)

Test System, Assay, Examination:

Becton Dickinson SedItainer ESR System

(07694)

Analyte: Spun Microhematocrit (9581)

Test System, Assay, Examination:

StatSpin Technologies CritSpin (58368)

Vulcon Technologies Microspin 24 (67098)

Speciality/Subspeciality: Urinalysis

Analyte: Urine Dipstick or Tablet Analytes,

Nonautomated (9641)

Test System, Assay, Examination:

Chemtech Labs URISTRIP (10294)

Genesis Labs DIA SCREEN Urine Reagent

Strips (22176)

TECO Diagnostics Urine Reagent Strips 1

(61151)

TECO Diagnostics Urine Reagent Strips 8

(61187)

TECO Diagnostics Urine Reagent Strips 9

(61219)

Announcement of Boards Approved by

HHS

In the personnel regulations at

§ 493.1443(b)(3)(i), individuals with an

earned doctoral degree in a chemical,

physical, biological or clinical

laboratory science and certification by a

board approved by HHS may qualify as

a laboratory director. Under

§ 493.1455(a), individuals who meet the

director qualification requirements of

§ 493.1443(b)(3)(i) may qualify as a

clinical consultant. Under these

provisions, four boards have been

approved by HHS, and HHS has

authority to recognize any certification

board having comparable requirements.

The American Board of

Histocompatibility and Immunogenetics

(ABHI) and the American Board of

Medical Genetics (ABMG) applied for

approval and submitted documentation

on the education, training and

experience required for certification.

Both boards were determined to have

credentialing requirements comparable

to the boards currently approved by

HHS, and ABHI and ABMG were

subsequently notified that they meet

CLIA requirements for board approval.

In this Notice we are announcing HHS

approval of ABHI and ABMG

certification to qualify individuals as

laboratory directors and clinical

consultants under the CLIA regulations.

Individuals with a doctoral degree in a

chemical, physical, biological or clinical

laboratory science and certification by

ABHI or ABMG meet the CLIA

qualification requirements to serve as a

laboratory director or clinical

consultant.

[FR Doc. 96–17097 Filed 7–5–96; 8:45 am]

BILLING CODE 4163–18–P