25944 Federal Register / Vol. 60, No. 93 / Monday, May 15, 1995 / Notices

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Public Health Service

Specific List for Categorization of

Laboratory Test Systems, Assays, and

Examinations by Complexity

AGENCY: Public Health Service, 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.

A compiled list of approximately

12,000 specific clinical laboratory test

systems, assays, and examinations

categorized by level of complexity was

published in the Federal Register on

July 26, 1993 (58 FR 39860). This notice

contains responses to the comments

submitted on those aspects of the July

26, 1993 publication that were subject to

comment. This Notice also announces

approximately 2900 additional test

systems, assays, and examinations that

have been categorized since the

publication of the compiled test list.

Included in this list of additional

categorizations are those test systems

which received 510(k) or premarket

approval from the Food and Drug

Administration (FDA) during the period

from September 1, 1992 to March 15,

1995. Also included are additional test

systems that were cleared prior to that

period and noted by commenters as

missing from the compiled test list.

DATES: Effective date: The

categorizations on this list 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 June 14, 1995.

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 initially

categorized 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.

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, (404) 488–

7655.

SUPPLEMENTARY INFORMATION: All

requests for recategorization received

during the 30 day comment period

provided in the July 26, 1993 Federal

Register notice (59 FR 39860) resulted

in extensive review of available product

information and the original complexity

scoring for the individual test system,

assay, or examination under

consideration. If the requestor submitted

new information, the test system was

rescored taking into account the new

information. Any changes in

categorization or reasons for not making

changes are addressed in this Notice

under the section Comments and

Responses.

Comments in response to the July 26,

1993 Notice, that requested additional

laboratory tests be waived of specific

CLIA requirements, were deferred in

light of the moratorium declared on

classifying testing devices as waived

tests on February 18, 1993. The CDC

lifted the moratorium on waiver on

December 19, 1994, and has now

resumed reviewing requests for waiver

status. On the date that the moratorium

was lifted, a letter was sent to

manufacturers of laboratory testing

devices, that included guidelines that

manufacturers may use to submit their

requests for waiver. Requests for waiver

will be evaluated in the order in which

they are received.

The public has requested that test

categorization information be made

available electronically. CDC is

providing computer access to this

information via the Internet. For further

information regarding this capability,

please call (404) 488–7655.

Comments and Responses

Comment: A manufacturer requested

clarification of what determines

whether a testing device is subject to

CLIA regulations. The commenter had

concerns about measuring versus

monitoring devices and ‘‘in-vitro’’

versus ‘‘in-vivo’’ testing.

Response: All clinical laboratory tests

performed on materials derived from the

human body for the purpose of

providing information for the diagnosis,

prevention, or treatment of any disease,

or the assessment of the health of,

human beings are subject to CLIA

regulations. The term ‘‘derived from the

human body’’ refers to any specimen

that is expelled from the human body,

withdrawn by procedures such as

phlebotomy, or, in the case of blood,

diverted from the circulatory path. The

circulatory path is defined as either the

body’s normal circulatory blood flow or

a path established by a life-sustaining

apparatus such as the ‘‘heart-lung’’

machine. To be considered as a normal

circulatory path, the ‘‘heart-lung’’

machine blood flow must be for the

purpose of sustaining life and not for

the purpose of performing testing. The

examination of materials removed or

diverted from either of these circulatory

paths (normal or life sustaining) meets

the definition of ‘‘in-vitro’’ testing and

is subject to the CLIA regulations. An

example of this type of procedure is

‘‘ex-vivo’’ blood gas testing performed

on a specimen diverted or removed by

means of an indwelling radial catheter.

(This indwelling catheter has not been

established for the purpose of sustaining

life and is outside the circulatory flow.)

All tests that meet the definition of ‘‘invitro’’ testing are subject to CLIA

regulations. ‘‘In-vivo’’ testing, i.e. testing

that is not removed or diverted from a

normal or life sustaining circulatory

path, is not subject to CLIA regulation

at the present time. An example of this

type of testing is pulse oximetry. Please

note, however, that we are presently

investigating the definitional and

technical issues, and necessary

revisions to the regulations that would

make ‘‘in-vivo’’ testing subject to CLIA.

Should it be determined at a later date

that it is subject to CLIA, proper notice

and opportunity for public comment

will be provided before this testing is

subject to CLIA regulation.

The context in which the test results

are being evaluated, i.e. monitoring

versus measurement, is not a

consideration for test complexity.

Comment: A few manufacturers

commented that some of their test

systems should not be categorized for

certain analytes because the company

did not supply the reagents for

performing these tests on the

instruments listed.

Response: Although the company

which manufactures a test system may

not have developed an assay procedure

for a particular analyte, it is quite

possible that another company could

design an assay procedure that has been

cleared by the FDA for use on the test

system. In such a situation, the analyte

will be listed as being available on the

test system. If the assay developed by

the reagent manufacturer does not

perform as it should on the test system,

it is the responsibility of the laboratory

performing the testing or the

manufacturer of the test system to

inform the FDA.
Federal Register / Vol. 60, No. 93 / Monday, May 15, 1995 / Notices 25945

Comment: Abbott Laboratories

commented that the compiled list

published on July 26, 1993 in the

Federal Register did not specifically

state whether the analytes Toxoplasma

gondii Antibodies, Cytomegalovirus

Antibodies, and Rubella Antibodies on

the Abbott IMX were for determining

IgG, IgM, or total antibodies.

Response: The analyte nomenclature

for antibodies to cytomegalovirus,

toxoplasmosis, and rubella does not

specify that the antibodies are total, IgG,

or IgM antibodies. In those instances

where a kit is used to identify the

antibodies, the test system name will

frequently specify that the antibodies

being detected are either total

antibodies, or IgG or IgM specific

antibodies. When the test system name

does not include the specific antibody,

as is the case with the automated

analyzers, then the generic

nomenclature for the antibody can refer

to total or specific antibodies. We do not

see this nomenclature as a problem

because the test complexity for the

procedure will be the same regardless of

whether the antibodies being detected

are total are specific antibodies.

Comment: One organization, after

learning of the recommendation by the

Clinical Laboratory Improvement

Advisory Committee (CLIAC) and

subsequent move of some HDL

procedures from high to moderate

complexity, requested recategorization

of HDL procedures back to high

complexity. The organization felt that

all HDL procedures should receive a

complexity score of ‘‘3’’ for the criteria

‘‘Training and Experience’’ and

‘‘Calibration, Quality Control or

Proficiency Testing Materials.’’ Another

manufacturer requested that numerous

HDL procedures be recategorized from

high complexity to moderate

complexity. Other commenters

indicated that based upon the process

for recategorization of 16 HDL

procedures from high to moderate

complexity announced in the July 26,

1993 Notice, there were some

inconsistencies in the application of this

process to other HDL procedures. The

commenters felt that the reagent

preparation requirements for some of

the HDL procedures that remained high

complexity were not sufficiently

complicated to warrant a higher score

than those HDL procedures that were

recategorized to moderate complexity.

The commenters requested that the

scores of these HDL procedures be

lowered from ‘‘2’’ to ‘‘1’’ in the criterion

‘‘Reagents and Materials Preparation’’

and that these procedures be

recategorized from high complexity to

moderate complexity.

Response: In response to the

continuing concerns regarding the

categorization of HDL cholesterol, CDC

once again reassessed the assigned

scores for HDL as performed by

automated methods. The original CLIAC

discussion had focused on the question

of the training and experience, and

interpretation and judgment necessary

for the analyst to make appropriate

decisions (e.g., evaluation of the

supernatant’s turbidity in the

pretreatment precipitation step) during

the testing process. It was on this issue

that CDC determined that analyst

interaction was of a lesser degree for

some automated methods than for

others. Therefore, following the CLIAC

recommendation for reevaluation of

these score assignments, some HDL

procedures were recategorized from

high to moderate complexity. In

response to the comments on the July

26, 1993 test list that announced this

group of recategorizations, we have

reevaluated all HDL procedures for

consistency in applying the criteria

‘‘Reagents and Materials Preparation’’.

Under this criteria, a score of ‘‘1’’ is

assigned when the manufacturer

provides that analyst with an automated

method of adding quantitative amounts

of precipitating reagent to the sample so

that analyst intervention is minimal, or

when the manufacturer provides the

analyst with a dedicated tube containing

a single precipitating reagent. As a

result of reevaluating the application of

this criteria, the following HDL

procedures have been recategorized

from high complexity to moderate

complexity: Abbott TDX, Abbott TDX

FLX, Abbott Vision Non Whole Blood

HDL Procedure, and the BioAutoMed

ASCA.

Comment: One commenter

recommended the recategorization of

‘‘large’’ hematology analyzers and

microscopy procedures from moderate

to high complexity.

Response: Using the seven criteria

established for categorization,

automated hematology analyzers, in

general, scored as moderate complexity.

Although the large automated

instruments used in hematology apply

multiple principles in their operation,

the instruments do not require extensive

analyst intervention or highly

specialized knowledge for operation.

Microscopy procedures were also

categorized by complexity using the

criteria established for test

categorization. Those procedures which

do not require an extensive level of

knowledge or training to perform the

evaluation, or do not require an

extensive level of judgment or

interpretive skill to recognize or

enumerate the cellular elements under

evaluation, generally scored as moderate

complexity.

Comment: One manufacturer

requested recategorization of some

alpha-fetoprotein procedures from high

complexity to moderate complexity.

Response: Material serum alphafetoprotein (AFP) procedures require

extensive training, interpretation and

judgment. The analyst must use patient

information related to the weeks of

gestation in conjunction with the

procedure value to obtain a reportable

result. Amniotic fluid specimens for

AFP may require preanalytic testing to

determine the presence of interfering

substances which can lead to result

misinterpretation or they may need

manipulation of the sample to produce

a clear supernatant. Extensive

interpretive and judgment skills are also

necessary to resolve technical problems,

such as improper specimen collection,

or determine the need for repeat testing.

All of these considerations are in

addition to those related to the

methodology of the testing procedure.

At the present time, all procedures for

maternal serum AFP and amniotic fluid

AFP score in the high complexity

category.

Comment: On professional

organization voiced support for the high

complexity scores given to any test that

involves the interpretation of cultures

and requires multiple steps for the

achievement of accurate results. This

organization suggested that other tests

now categorized as moderate

complexity should be categorized as

high complexity for the same reasons.

The example given was the direct

Coombs test, which the organization

indicated would yield a false negative

result if the patient read blood cells

were washed insufficiently.

Response: We appreciate the

organization’s statement of support

concerning the categorization scores of

microbiology culture methods. In regard

to the direct antiglobulin test (DAT), or

direct Coombs, we feel that this assay is

appropriately categorized as moderate

complexity since the procedural skills

are easily acquired, the reagents are

stable and ready to use, and limited

knowledge and judgment is required.

The CLIA regulations to do relieve the

laboratory of its responsibility to

evaluate the competency of its staff or

provide sufficient training on

supervision for the correction of any

technical deficiencies. Training on

proper wash techniques to prevent false

negative DAT results should be an

integral part of the training of all

analysts performing these procedures.

We do not feel that the degree of
25946 Federal Register / Vol. 60, No. 93 / Monday, May 15, 1995 / Notices

decision making, interpretation, and

judgment required to perform a DAT

approaches the level required to isolate

and identify organisms from culture.

Comment: Several commenters

expressed confusion concerning the

categorization of rapid strep test kits.

Some referred to them as high

complexity procedures.

Response: Most of the tests that detect

streptococcal antigen directly from a

throat swab are categorized as moderate

complexity tests. They require some

knowledge, training and judgment to

accurately perform the procedure. They

are not categorized as high complexity

tests because they do not require the

level of knowledge, training, experience

and interpretative skill that is required

of a high complexity procedure such as

isolation and identification of an

organism from culture.

Comment: Several commenters

requested that throat and urine cultures,

and urine susceptibility testing be

recategorized from high to moderate

complexity. A few other commenters

agreed with high complexity

categorization of microbiology cultures

due to the advanced level of

interpretation, judgment, knowledge,

and experience required to obtain an

accurate result when performing these

procedures.

Response: Isolation, identification,

and susceptibility testing of

microorganisms from culture is a

complex process regardless of the

source of the culture. It requires

significant knowledge, training, and

interpretation for the selection and

performance of the individual test

components in this process, which may

include staining for microscopic

evaluation, subculturing, and

performing the appropriate biochemical

analyses. Taking these factors into

consideration when scoring for

complexity, these test systems are

appropriately categorized as high

complexity.

Comment: One commenter asked

whether the use of general microbiology

culture media, such as sheep blood agar,

was categorized. There has also been

some confusion as to whether

inoculation of primary culture media or

the determination of a ‘‘No growth’’

final culture result is considered a high

complexity test.

Response: Primary inoculation of

microbiology culture media (e.g. blood

agar, chocolate agar, MacConkey agar,

heart infusion broth) is not considered

a complete test system under the CLIA

regulations. The process of isolation and

identification from the primary culture

is considered a total test system. 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. We have previously stated that

if a culture is read even to the point of

providing a result of ‘‘No growth’’ it is

considered to be an identification from

culture, and, therefore, the laboratory

reporting the result must be certified to

perform the entire culture procedure. In

response to the confusion as to whether

the determination that there is either

growth or no growth on primary culture

plates, including the final reporting of a

‘‘No growth’’ culture result, falls into

the moderate or high complexity

category, we have created a new test

system designation, (22167) ‘‘Growth/

No Growth of Bacteria on Solid Culture

Media’’, which is categorized as

moderate complexity. This test system

designation applies to a result

determined after examining a culture

from any body site, that was initially

inoculated on solid culture agar or

media. It does not apply to cultures

inoculated into a broth medium such as

heart infusion broth, thioglycollate

medium, or to conventional broth blood

cultures. Final reports for this moderate

complexity test system are limited to

‘‘Growth’’, ‘‘Growth—referred for

identification or interpretation’’, or ‘‘No

growth’’. A result of ‘‘No growth’’ means

that there are NO bacterial colonies on

the media after incubation. The

presence of ‘‘normal flora’’,

contaminants, or any organism not

considered a pathogen could not be

interpreted or reported as ‘‘No growth’’.

Individual biochemical tests that are

performed as part of the total

identification process (e.g. oxidase,

catalase) are not categorized as separate

tests. Those test systems or kits that

usually contain a group of biochemical

or serological tests, and result in the

definitive identification of a

microorganism are categorized. Several

selective culture media that do not

require transfer from the initial plate,

and result in preliminary identification

of a specific microorganism, have been

categorized as moderate complexity

tests. The degree of training and

experience, judgment and interpretive

skills required to recognize one specific

colony type or reaction on these

selective media is significantly less than

what is required for selecting specific

colonies from the growth on primary

culture plates, and performing definitive

identification tests on pure cultures of

these organisms.

Comment: One commenter requested

that all of the test systems for

dermatophytes that have been

categorized and published as moderate

complexity should be recategorized as

high complexity due to the advanced

level of interpretation, judgment,

knowledge, and experience required to

obtain an accurate result.

Response: The test systems for

dermatophytes that have been

categorized as moderate complexity are

tests performed on selective media that

detect the presence or absence of

dermatophytes, but do not identify these

fungi. These test systems require

significantly less knowledge,

experience, interpretation, and

judgment than high complexity cultures

for isolation and complete identification

of fungi, in which organisms must be

transferred and identification

procedures performed. Based on the

information we have received to date,

we believe that the test systems for

dermatophytes using selective media are

appropriately categorized as moderate

complexity.

Comment: Several commenters

requested that the following analytes

and test systems be recategorized from

moderate to high complexity:

N. gonorrhoeae (from urogenital or

rectal only)

Test system—All presumpt. ID using

select, media, oxidase, and gram

stain

Streptococcus, group A (from throat

only)

Test system—All presumpt. ID w/

selective media, hemolysis, and

bacitracin

Response: These two tests for

presumptive identification of a single

microorganism on selective media from

culture of a specific body site were

placed in the moderate complexity

category because the knowledge,

training, interpretation and judgment

required is significantly less than that

needed to distinguish multiple

organisms and determine the presence

of pathogens, normal flora, or

contamination in a culture initially

inoculated on general nonselective

culture media. For these reasons, we

disagree with these commenters, and

these tests will remain categorized as

moderately complex.

Comment: One commenter requested

that Gram stain procedures performed

on endocervical specimens be

recatogorized from moderate to high

complexity.

Response: Gram stains from urethral

and endocervical smears are categorized

as moderate complexity procedures,

while Gram stains from other sources

are categorized as high complexity

procedures as determined by the scoring

criteria established for test

categorization. Smears from urethral

and endocervical sources do not tend to
Federal Register / Vol. 60, No. 93 / Monday, May 15, 1995 / Notices 25947

contain the variety of microorganisms or

cell types that can be seen on smears

taken from other sources. Therefore, the

knowledge, training and experience,

interpretation and judgment required to

interpret a Gram stained smear from

urethral or endocervical sources is not

as extensive as that required to interpret

gram stain smears from other sources.

Although we agree that there is a

difference in the interpretation and

judgment required for Gram stained

smears from urethral versus

endocervical sources, we do not believe

that difference is sufficient to place the

Gram stain evaluations performed on

endocervical smears into high

complexity. This issue was presented to,

and discussed by, CLIAC. The CLIAC

felt that CDC’s assessment of the level

of difficulty for performing the

evaluations was appropriate, thus the

Gram stain of endocervical smears will

remain in the moderate complexity

category.

Comment: One commenter requested

that the MAST CLA–1 Luminometer

System be recategorized from high to

moderate complexity. The commenter

noted that this is a different request

from earlier correspondence requesting

that the MAST Allergy Densitometer

System be recategorized from high to

moderate complexity.

Response: We would like to

emphasize that we assess the

complexity of every analyte on each

individual instrument and do not

categorize instruments by complexity

without analytes. Additionally, the

entire testing process of preanalytic,

analytic, and postanalytic steps,

including the process for determination

of results, are evaluated for

categorization. Thus the instrument

used to read the final results is not

graded independently of the total testing

process. The analytes for which the

MAST CLA Allergy System has been

categorized as a high complexity test

system are ‘‘allergen specific IgE’’ and

‘‘immunoglobulins IgE’’.

As in our earlier response regarding

the MAST CLA Allergy System, we

maintain that high complexity is the

appropriate complexity rating for the

MAST CLA Allergy System. While it is

true that there are two different means

to measure test results for this

procedure, i.e., by densitometer or by

using the MAST Chemiluminescent

Analyzer (CLA–1), these measuring

devices do not significantly change the

complexity of the entire testing process.

Substantial training and experience are

required to perform the complete

procedure. The steps in the procedure

are manually executed and are

performed in the same way except for

result reading and data reduction.

Regardless of the reading system used,

the analyst must prepare multiple

reagents prior to testing, some of which

require special handling; the process

requires manual addition of specimen to

the chamber using a syringe, followed

by timed incubation, multiple wash

steps, addition of reagents, a second

timed incubation and more wash steps.

It is only after these second wash steps

are completed that the CLA–1

Chemiluminescent Analyzer automates

the photodevelopment, result reading

and data reduction, while the

Densitometer system requires manual

photodevelopment, followed by result

reading and data reduction on the

instrument.

We have reviewed the MAST CLA

Allergy System taking into account both

methods of final result determination

and have concluded that due to the

knowledge, training and skills necessary

to perform the IgE assays properly, this

test system belongs in the high

complexity category. However, for

purposes of clarification, we have listed

the system in this Notice in such way

that the method of result determination

is clearly specified, and it is now listed

twice, as follows: (40176) MAST CLA

Allergy System (densitometer) and

(40177) MAST CLA–1

Chemiluminescent Allergy System. Both

are categorized as high complexity.

Comment: One commenter requested

that the Scandipharm CF INDICATOR

SWEAT TEST SYSTEM (CFIS) be given

the same status as the physicianperformed microscopy procedures so

that access to cystic fibrosis screening

would not be restricted.

Response: The Scandipharm CF

INDICATOR SWEAT TEST SYSTEM

(CFIS) does not meet the criteria for

physician-performed microscopy

procedures (PPM). The PPM

examinations include only specific

microscopic procedures performed on

specimens that are derived from

patients as part of the physical

examination. We have received

numerous comments suggesting that

another level of complexity be

established that is intermediate between

waived and moderate complexity. HHS

is taking these suggestions under

advisement.

Additions to Waived Category

The Ames Glucometer ENCORE QA

Blood Glucose Meter (04423) and the

Ames Glucometer QA Blood Glucose

Meter (04422) have been deleted from

the list of moderate complexity tests and

have been added to the list of waived

tests. Section § 493.15(c) of the CLIA

regulations lists ‘‘blood glucose by

glucose monitoring devices cleared by

the FDA specifically for home use’’ as

waived tests. The Ames Glucometers are

glucose monitoring devices that were

recently cleared by the FDA for home

use; therefore, they are now listed as

waived tests.

Please note that in this list of

additions to the CLIA test categorization

list, we have included the test systems

(58311) Separation Technology STI

HemataStat II and (58309) Separation

Technology STI HemataStat Model C70

under the analyte (9581) Spun

Microhematocrit as waived procedures.

On previous lists of waived procedures,

we did not list individual test systems

capable of obtaining results for spun

hematocrit, but rather listed the allinclusive test system designation

(04420) ‘‘All Spun Microhematocrit

Procedures’’. The two Separation

Technology test systems have been

listed in response to requests from the

public to clarify that these test systems

are indeed spun microhematocrit

procedures. The all-inclusive test

system designation (04420) will

continue to be included on the waived

list to indicate that, at the present time,

all spun microhematocrit test systems

are waived procedures. We do

encourage the public to contact us if

there are questions about whether other

specific test systems meet this

definition. In the future, we will include

all test systems by manufacturer’s name

on the waived list.

Additions

In this publication, we are

announcing the categorization of two

laboratory procedures that are normally

performed in dental offices. The dental

procedures for (4965) Proteolytic

enzymes are listed in the speciality of

General Chemistry, and for (1317)

Dental plaque, in bacteriology.

Corrections

The following corrections to the list of

test systems, assays and examinations

published previously in the Federal

Register are based on supplemental

information provided by the

commenters during the comment period

or as a result of corrections of data entry

errors. The CDC should be notified of

any changes in manufacture or test

system names so that these changes can

be included in the next published test

list.

Scandipharm CF Indicator (58240):

The Scandipharm CF Indicator

(58240) (Cystic Fibrosis Sweat Test) has

been deleted from the high complexity

category and placed in the moderate

complexity category based upon new
25948 Federal Register / Vol. 60, No. 93 / Monday, May 15, 1995 / Notices

information supplied by the

manufacturer regarding the sample

collection. Previous information had

indicated that the amount of analyst

involvement in the collection of the

sample was more extensive than that

indicated in the new information. Upon

evaluation of this information supplied

by the manufacturer, it was determined

that the training and experience and

interpretation and judgment required by

the analyst to successfully perform the

sample collection is not as extensive as

originally indicated. As a result of the

adjustment of scores for relevant

criteria, the Scandipharm CF Indicator

now registers a total score that places it

in the moderate complexity category.

International Technidyne Corporation:

As noted in the preamble to the

compiled test list, the analyte heparin

was removed from the International

Technidyne Corporation systems

because the relevant analytes were

either (2539) heparin dose response

(HDR) or (2538) heparin/protamine

titration (HPT). These systems were

inadvertently omitted in the compiled

test list for the analytes HDR or HPT.

This error has been corrected in the

database and the systems are listed in

this Notice under the appropriate

analytes.

(2502) HCG, Serum, Quantitative:

The analyte, HCG, Serum,

Quantitative, has been clarified as

(2502) HCG, Beta, Serum, Quantitative.

(4945) Protamine Rate Titration (PRT)

The analyte (4945) Protamine Rate

Titration for the International

Technidyne Hemochron test systems

has been corrected to (4945) Protamine

Response Test (PRT).

MicroProbe Affirm VP Identification Kit

(40135) for the detection and

identification of (2212) Gardnerella

vaginalis:

Identification of G. vaginalis using the

MicroProbe Affirm VP Identification Kit

is categorized as a moderate complexity

test, and is correctly listed as such on

page 39879 of the July 26, 1993 Federal

Register notice, in the List of Previously

Unpublished Categorizations. The

erroneous listing of this analyte and test

system as high complexity in the

compiled test list of categorizations has

been corrected in this Federal Register

Notice.

Bio-Scan Bio-Gen:

The manufacturer’s name was

inadvertently omitted from several

entries for Bio-Gen test systems, listed

under (9641) Urine Dipstick or Tablet

Analytes, Nonautomated. These entries

have been corrected to read Bio-Scan

Bio-Gen in this notice.

Access Medical Systems ImmunoClone

HCG Test (04377):

An entry under HCG, Serum,

Qualitative, was incorrectly listed as

Access Medical Systems ImmunoClone

(direct Ag/visual) (04311) and has been

revised to read Access Medical Systems

ImmunoClone HCG Test (04377).

bioMerieux Vitek Vidas (07434):

The test system bioMerieux Vitek

Vidas (07434) for the analyte (6111)

Thyroxine, Free (FT4) has been revised

to Vitek Systems Vidas (67038) for

consistency in the listing of test

systems, assays, and examinations.

Incorrect Test System Codes

Incorrect test system codes were

inadvertently assigned to several

systems on the previous test list and

have been corrected as follows:

Gen-Probe Legionella Rapid Diag.

Systems (including culture) was

incorrectly assigned the test system

code (22126). The correct code is

(22160).

Gen-Probe M. Pneumoniae Rapid

Diag. Systems (including culture) was

incorrectly assigned the test system

code (22127). The correct code is

(22161).

Gull Laboratories RSV-Mab Test

(direct antigen) was incorrectly assigned

the test system code (22128). The

correct code is (22162).

Seradyn Colorvue—Giardia (direct

Ag/visual) was incorrectly assigned the

test system code (58100). The correct

code is (58296).

Seradyn Colorvue—Cryptosporidium

(direct Ag/visual) was incorrectly

assigned the test system code (58101).

The correct code is (58297).

Deletions

(4023) Myoglobin:

The analyte myoglobin was listed in

both the General Chemistry and

Immunology speciality areas. It has been

deleted from the Immunology speciality

area.

(0444) Anti-Reticulin Antibodies:

Anti-Reticulin Antibodies on the

Scimedx Auto Screen Test System

(58016) has been deleted because it has

not been cleared by FDA for use in the

clinical laboratory.

(5503) Respiratory viruses (Influenza

A&B, parainfluenza):

The analyte Respiratory viruses

(Influenza A&B, parainfluenza) has been

deleted and replaced with the following

analytes: (0410) Adenovirus, (2828)

Influenza A, (2829) Influenza B, (4959)

Parainfluenza 1, (4960) Parainfluenza 2,

(4961) Parainfluenza 3, and (5503)

Respiratory syncytial virus.

(0456) Antithrombin III (ATIII):

Instrumentation Laboratory IL ACL

100 (28073) has been deleted from the

analyte (0456) Antithrombin III (ATIII)

because this analyte is not available on

this system.

(0703) Beta-2 microglobulin:

Du Pont Medical Products aca II

(13172) has been deleted from the

analyte beta-2 microglobulin because

this analyte is not available on this

system.

(4908) Platelet Count:

The test systems Abbott Cell-Dyn 400

(04230), Abbott Cell-Dyn 500 (04231),

and Abbott Cell-Dyn 700 (04233) have

been deleted from the analyte platelet

count because these instruments do not

analyze this analyte.

Analyte Nomenclature and Use

We will use the term ‘‘direct

bilirubin’’ to refer to the analyte

‘‘conjugated bilirubin’’.

Due to the different nomenclature

systems associated with many flow

cytometer analytes, we will list each

analyte by the terminology furnished by

the manufacturer.

Thyroid Peroxidase Autoantibodies

(TPO) and Anti-Thyroid Microsomal

Antibodies (AMA) refer to the same

analyte. To avoid confusion, we will list

the analyte nomenclature used by the

manufacturer in the package insert for

the test system being categorized.

For purposes of clarification, the

analyte (1033) for Cortisol, Urine has

been modified to read Cortisol, Urine

(direct procedure), and a new analyte

(1095) Cortisol, Urine (extraction

procedure) has been established.

Speciality/Subspeciality Changes

In previous publications of the Test

Categorization List, analyte/test systems

were assigned to speciality/

subspeciality categories based upon the

most recognized area in the clinical

laboratory where these procedures are

generally performed. In an effort to

coordinate regulatory responsibilities

between the Health Care Financing

Administration (HCFA) and the CDC,

we have redefined the speciality/

subspeciality categories for some

analytes to conform to HCFA’s common

procedure coding system for Medicare

payment. Consequently, in this

publication, you will note that the

analytes (0476) Acetylcholine/choline,
Federal Register / Vol. 60, No. 93 / Monday, May 15, 1995 / Notices 25949

(0426) Aminoglycosides, (0705) Blood

Lead, (1012) Carboxyhemoglobin, (2541)

Histamine, and (3712) Lithium have

been moved to Toxicology; the analytes

(0424) Alpha Fetoprotein—tumor

marker, (1051) C1-Esterase Inhibitor

(C1INH), and (4927) Platelet Antibody—

detection have been moved to General

Immunology; the analytes (1049) Cancer

Antigen 125 (CA125), (1013)

Carcinoembryonic Antigen (CEA),

(1015) Ceruloplasmin, (2511)

Haptoglobin, (3717) Lysozyme, (4911)

Prealbumin, (4919) Prostatic Specific

Antigen (PSA), (4920) Protein Fractions,

(6114) Transferrin, and (6129) Trypsin

have been moved to General Chemistry;

the analyte (4021) Malarial Parasite has

been moved to Parasitology. Also, a

number of analytes that were previously

listed under the speciality of General

Chemistry or the subspeciality of

Toxicology are now listed under the

subspeciality of Endocrinology. These

analytes, with their respective codes,

are:

(0106) 17 Ketosteroid

(0102) 17 OH Progesterone

(0103) 17 OH Progesterone, Neonatal

(0101) 5-Hydroxyindolacetic Acid (5-

HIAA)

(0472) Adenosine Monophosphate,

Cyclic (cAMP)

(0458) Adrenocorticotropic Hormone

(ACTH)

(0459) Aldosterone

(0466) Androstanediol Glucuronide (3

alpha-diol G)

(0460) Androstenedione

(0479) Angiotensin I

(1040) Calcitonin

(1056) Catecholamines, Plasma

(1055) Catecholamines, Urine

(1032) Cortisol

(1033) Cortisol, Urine (direct procedure)

(1095) Cortisol, Urine (extraction

procedure)

(1043) Cyclic AMP

(1309) Dehydroepiandrosterone (DHEA)

(1310) Dehydroepiandrosterone Sulfate

(DHEA–SO4

(1611) Erythropoietin

(1605) Estradiol

(1606) Estriol-Total

(1607) Estriol-unconjugated

(1908) Follicle Stimulating Hormone

(FSH)

(2205) Gastrin

(2206) Glucagon

(2502) HCG, Beta, Serum, Quantitative

(2501) HCG, Serum, Qualitative

(2555) HCG, Total, Serum, Quantitative

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

(2534) HCG, Urine, Quantitative

(2543) HCG, Whole Blood, Qualitative

(2545) Homovanillic Acid (HVA)

(2547) Human Growth Hormone

(2533) Human Placental Lactogen (hPL)

(2812) Insulin

(2818) Insulin-like Growth Factor-1

(IGF–1)

(3713) Luteinizing Hormone (LH)

(4025) Metanephrines, Urine

(4934) Parathyroid Hormone—CTerminal

(4924) Parathyroid Hormone—Intact

(4925) Parathyroid Hormone—Midmolecule (PTH–M)

(4914) Progesterone

(4915) Prolactin

(5515) Renin

(5820) Serotonin

(5819) Sex Hormone Binding Globulin

(6102) Testosterone

(6122) Testosterone, Free

(6110) Thyroid Binding Globulin (TBG)

(6106) Thyroid Stimulating Hormone

(TSH)

(6107) Thyroid Stimulating Hormone

(TSH) (Neonatal)

(6108) Thyroid Stimulating Hormone—

high sens. (TSH–HS)

(6109) Thyroxine (T4)

(6123) Thyroxine (T4), Neonatal

(6110) Thyroxine Binding Globulin

(TBG)

(6111) Thyroxine, Free (FT4)

(6119) Triiodothyronine (T3)

(6120) Triiodothyronine Uptake (T3U)

(TU)

(6121) Triiodothyronine, Free (FT3)

(6710) Vanillylmandelic Acid (VMA)

Dated: May 2, 1995.

Philip R. Lee,

Assistant Secretary for Health.

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 &/or Anaerobic

Organisms-unlimited sources (0412)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Difco ESP Blood Culturing System (13275)

Growth/No Growth of Bacteria on Solid

Culture Media (22167)

Organon Teknika Bact/Alert 120 (46148)

ANALYTE: Aerobic Organisms from urine

specimens only (0468)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Difco EZ Streak Urine Culture Device

(colony court only) (13311)

Savyon Diagnostic DIASLIDE (colony

count only) (58290)

Traditional Blood Agar Streak Plate

(colony count only) (61131)

Vitek Systems Bac-T-Screen 2000

(bacteriuria) (67039)

Vitek Systems Bac-T-Screen 402A

(bacteriuria) (67049)

Vitek Systems Bac-T-Screen 500

(bacteriuria) (67050)

ANALYTE: Chlamydia (1016)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Abbott TestPack Chlamydia (direct

antigen/visual) (04518)

Wampole Clearview Chlamydia (direct

antigen/visual) (70140)

ANALYTE: Clostridium difficile (1022)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Meridian Diagnostics ImmunoCard C.

difficile (dir.Ag/visual) (40165)

ANALYTE: Gardnerella vaginalis (2212)

TEST SYSTEM, ASSAY OR

EXAMINATION:

MicroProbe Affirm VP Microbial

Identification Test Kit (40135)

MicroProbe Affirm VPIII Microbial

Identification Test (40163)

ANALYTE: Helicobacter pylori (2512)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Serim PyloriTek Test Kit (58338)

ANALYTE: Streptococcus, group A (5810)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Becton Dickinson Precise STREP A (direct

antigen/visual) (07426)

Syntron QuikPac Strep A (EIA) Test (direct

antigen/visual) (58291)

Wampole Clearview Strep A (direct

antigen/visual) (70141)

ANALYTE: Streptococcus, group A (from

throat only) (5828)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Medix Biotech BESTest Strep A (40193)

Quidel QuickVue One-Step Strep A Test

(52024)

ANALYTE: Streptococcus, group B (5811)

TEST SYSTEM, ASSAY OR

EXAMINATION:

BioStar Strep B OIA (direct antigen/visual)

(07540)

ANALYTE: Vibrio cholerae (6716)

TEST SYSTEM, ASSAY OR

EXAMINATION:

New Horizons CholeraScreen (43084)

SPECIALITY/SUBSPECIALITY:

Endocrinology

ANALYTE: Cortisol (1032)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Boehringer Mannheim ES 300 AL (07524)

Boehringer Mannheim Hitachi 914 (07546)

Ciba Corning ACS 180 (10046)

Cirrus Diagnostics Immulite (10159)

Sanofi Pasteur Access Immunoassay

System (58257)

Schiapparelli Biosystems ACE Clinical

Chemistry System (58288)
25950 Federal Register / Vol. 60, No. 93 / Monday, May 15, 1995 / Notices

Vitek Systems Vidas (67038)

ANALYTE: Cortisol, Urine (direct procedure)

(1033)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Abbott TDX (04071)

Sanofi Pasteur Access Immunoassay

System (58257)

ANALYTE: Dehydroepiandrosterone (DHEA)

(1309)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Serono Baker SR 1 (58090)

ANALYTE: Dehydroepiandrosterone Sulfate

(DHEA–SO4) (1310)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Cirrus Diagnostics Immulite (10159)

ANALYTE: Estradiol (1605)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Baxter Stratus II (07051)

Baxter Stratus IIntellect (07376)

Boehringer Mannheim ES 300 AL (07524)

Ciba Corning ACS 180 (10046)

Cirrus Diagnostics Immulite (10159)

PB Diagnostics Systems OPUS (49001)

PB Diagnostics Systems OPUS Magnum

(49097)

PB Diagnostics Systems OPUS PLUS

(49098)

TOSOH A1A–1200 (61040)

TOSOH A1A–600 (61039)

Vitek Systems Vidas (67038)

Wallac Oy AutoDELFIA (70167)

ANALYTE: Estriol-unconjugated (1607)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Wallac Oy AutoDELFIA (70167)

ANALYTE: Follicle Stimulating Hormone

(FSH) (1908)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Abbott AxSYM (04532)

Boehringer Mannheim ES 300 AL (07524)

Du Pont ACA III with aca plus

Immunoassay System (13253)

Du Pont ACA IV with aca plus

Immunoassay System (13254)

Du Pont ACA SX with aca plus

Immunoassay System (13313)

Du Pont ACA Star with aca plus

Immunoassay System (13358)

Du Pont ACA V with aca plus

Immunoassay System (13255)

Organon Teknika AuraFlex (46152)

PB Diagnostics Systems OPUS Magnum

(49097)

PB Diagnostics Systems OPUS PLUS

(49098)

Roche Cobas Core (55119)

Sanofi Pasteur Access Immunoassay

System (58257)

Syva Vista Immunoassay System (58221)

Vitek Systems Vidas (67038)

Wallac Oy AutoDELFIA (70167)

ANALYTE: HCG, Beta, Serum, Quantitative

(2502)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Abbott AxSYM (04532)

Boehringer Mannheim ES 300 AL (07524)

Du Pont ACA Star with aca plus

Immunoassay System (13358)

PB Diagnostics Systems OPUS Magnum

(49097)

PB Diagnostics Systems OPUS PLUS

(49098)

Sanofi Pasteur Access Immunoassay

System (58257)

Syva Vista Immunoassay System (58221)

Vitek Systems Vidas (67038)

Wallac Oy AutoDELFIA (70167)

ANALYTE: HCG, Serum, Qualitative (2501)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Abbott TestPack PLUS hCG COMBO

(04375)

Access Medical Systems ImmunoCLONE

hCG Test (04377)

Applied Biotech SureStep Combo hCG

(04528)

Disease Detection International Pro-Step

PT hCG (13271)

Disease Detection International Pro-Step

hCG (13270)

King’s Bay Prelude hCG Combo Kit (34062)

Mainline Technology MAINLINE Confirms

hCG (40190)

Princeton BioMeditech BioSign hCG One

Step Pregnancy Test (49080)

Quidel QuickVue One-Step hCG Combo

Test (52022)

SA Scientific SAS Serum/Urine hCG

(58283)

Stanbio QuPid Plus hCG Pregnancy Test

(58326)

Syntron Bioresearch QuikPac II hCG

Combo Kit (58353)

TECH–CO Visual HCG Pregnancy Test

(61099)

True Medix Beta Spec hCG (61139)

Unipath Clearview HCG DUO (64031)

ANALYTE: HCG, Total, Serum, Quantitative

(2555)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Ciba Corning ACS 180 (10046)

PB Diagnostics Systems OPUS (49001)

PB Diagnostics Systems OPUS Magnum

(49097)

PB Diagnostics Systems OPUS PLUS

(49098)

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

TEST SYSTEM, ASSAY OR

EXAMINATION:

Applied Biotech Pregslide HCG Test

(04498)

Diagnostic Specialties Pregna-Cert (13276)

J & S Medical Accutex B–HCG Latex Test

(31011)

SA Scientific SAS Direct Monoclonal hCG

(58319)

SA Scientific SAS Monoclonal HCG-Slide

(58281)

ANALYTE: Human Growth Hormone (GH)

(2547)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Wallac Oy AutoDELFIA (70167)

ANALYTE: Insulin (2812)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Boehringer Mannheim ES 300 AL (07524)

ANALYTE: Luteinizing Hormone (LH) (3713)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Abbott AxSYM (04532)

Boehringer Mannheim ES 300 AL (07524)

Du Pont ACA III with aca plus

Immunoassay System (13253)

Du Pont ACA IV with aca plus

Immunoassay System (13254)

Du Pont ACA Star with aca plus

Immunoassay System (13358)

Du Pont ACA V with aca plus

Immunoassay System (13255)

Organon Teknika AuraFlex (46152)

PB Diagnostics Systems OPUS Magnum

(49097)

PB Diagnostics Systems OPUS PLUS

(49098)

Roche Cobas Core (55119)

Sanofi Pasteur Access Immunoassay

System (58257)

Syva Vista Immunoassay System (58221)

Vitek Systems Vidas (67038)

Wallac Oy AutoDELFIA (70167)

ANALYTE: Parathyroid Hormone—Intact

(4924)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Cirrus Diagnostics Immulite (10159)

ANALYTE: Progesterone (4914)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Baxter Stratus II (07051)

Baxter Stratus IIntellect (07376)

Boehringer Mannheim ES 300 AL (07524)

Ciba Corning ACS 180 (10046)

Cirrus Diagnostics Immulite (10159)

TOSOH A1A–1200 (61040)

TOSOH A1A–600 (61039)

Wallac Oy AutoDELFIA (70167)

ANALYTE: Prolactin (4915)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Abbott AxSYM (04532)

Boehringer Mannheim ES 300 AL (07524)

Cirrus Diagnostics Immulite (10159)

Du Pont ACA III with aca plus

Immunoassay System (13253)

Du Pont ACA IV with aca plus

Immunoassay System (13254)

Du Pont ACA SX with aca Immunoassay

System (13313)

Du Pont ACA Star with aca plus

Immunoassay System (13358)

Du Pont ACA V with aca plus

Immunoassay System (13255)

PB Diagnostics Systems OPUS Magnum

(49097)

PB Diagnostics Systems OPUS PLUS

(49098)

Roche Cobas Core (55119)

Sanofi Pasteur Access Immunoassay

System (58257)

Syva Vista Immunoassay System (58221)

Vitek Systems Vidas (67038)

Wallac Oy AutoDELFIA (70167)

ANALYTE: Sex Hormone Binding Globulin

(5819)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Cirrus Diagnostics Immulite (10159)

ANALYTE: Testosterone (6102)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Ciba Corning ACS 180 (10046)

ANALYTE: Thyroid Stimulating Hormone

(TSH) (6106)

TEST SYSTEM, ASSAY OR

EXAMINATION:
Federal Register / Vol. 60, No. 93 / Monday, May 15, 1995 / Notices 25951

Bio-Rad RADIAS System (07493)

Cirrus Diagnostics Immulite (10159)

Du Pont ACA Star with aca plus

Immunoassay System (13358)

Organon Teknika AuraFlex (46152)

PB Diagnostics Systems OPUS Magnum

(49097)

PB Diagnostics Systems OPUS PLUS

(49098)

Roche Cobas Core (55119)

Vitek Systems Vidas (67038)

Wallac OY AutoDELFIA (70167)

ANALYTE: Thyroid Stimulating Hormone

(TSH) (Neonatal) (6107)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Bio-Rad RADIAS System (07493)

ANALYTE: Thyroid Stimulating Hormone—

high sens. (TSH–HS) (6108)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Bio-Rad RADIAS System (07493)

Boehringer Mannheim ES 300 AL (07524)

Sanofi Pasteur Access Immunoassay

System (58257)

Wallac Oy AutoDELFIA (70167)

ANALYTE: Thyroxine (T4) (6109)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Abbott AxSYM (04532)

Beckman Synchron CX 5 CE (07491)

Becton Dickinson IQ Immunochemical

System (07429)

Boehringer Mannheim ES 300 AL (07524)

Boehringer Mannheim Hitachi 911 (07377)

Boehringer Mannheim Hitachi 914 (07546)

Du Pont ACA Star (13357)

Du Pont Dimension XL (13355)

LSI ASCA Chemistry System (37069)

Olympus AU 5041 (46145)

Olympus AU 5121 (46087)

Olympus AU 5200 (46143)

Organon Teknika AuraFlex (46152)

PB Diagnostics Systems OPUS Magnum

(49097)

PB Diagnostics Systems OPUS PLUS

(49098)

Roche Cobas Core (55119)

Sanofi Pasteur Access Immunoassay

System (58257)

Schiapparelli Biosystems ACE Clinical

Chemistry System (58288)

Technicon OPERA Clinical Chemistry

System (61161)

Vitek Systems Vidas (67038)

Wallac Oy AutoDELFIA (70167)

ANALYTE: Thyroxine Binding Globulin

(TBG) (6110)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Boehringer Mannheim ES 300 AL (07524)

Technicon Immuno 1 System (61042)

ANALYTE: Thyroxine Uptake (T4U) (TU)

(6139)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Du Pont Dimension XL (13355)

Schiapparelli Biosystems ACE Clinical

Chemistry System (58288)

Syva Vista Immunoassay System (58221)

Vitek Systems Vidas (67038)

ANALYTE: Thyroxine, Free (FT4) (6111)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Abbott AxSYM (04532)

Bio-Rad RADIAS System (07493)

Boehringer Mannheim ES 300 AL (07524)

Cirrus Diagnostics Immulite (10159)

Organon Teknika AuraFlex (46152)

PB Diagnostics Systems OPUS (49001)

Roche Cobas Core (55119)

Sanofi Pasteur Access Immunoassay

System (58257)

Technicon Immuno 1 System (61042)

Vitek Systems Vidas (67038)

Wallac Oy AutoDELFIA (60167)

ANALYTE: Triiodothyronine (T3) (6119)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Abbott AxSYM (04532)

Boehringer Mannheim ES 300 AL (07524)

Organon Teknika AuraFlex (46152)

PB Diagnostics Systems OPUS Magnum

(49097)

PB Diagnostics Systems OPUS PLUS

(49098)

Roche Cobas Core (55119)

Sanofi Pasteur Access Immunoassay

System (58257)

TOSOH A1A–120DX (61154)

Vitek Systems Vidas (67038)

Wallac Oy AutoDELFIA (70167)

ANALYTE: Triiodothyronine Uptake (T3U)

(TU) (6120)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Abbott TDX FLx (04072)

Beckman Synchron CX 5 CE (07491)

Becton Dickinson IQ Immunochemical

System (07429)

Boehringer Mannheim ES 300 AL (07524)

Boehringer Mannheim Hitachi 914 (07546)

Du Pont ACA Star (13357)

LSI ASCA Chemistry System (37069)

Olympus AU 5041 (46145)

Olympus AU 5121 (46087)

Olympus AU 5200 (46143)

Organon Teknika AuraFlex (46152)

PB Diagnostics Systems OPUS Magnum

(49097)

PB Diagnostics Systems OPUS PLUS

(49098)

Sanofi Pasteur Access Immunoassay

System (58257)

SPECIALITY/SUBSPECIALITY: General

Chemistry

ANALYTE: Acid Phosphatase (0407)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Du Pont ACA Star (13357)

Du Pont Dimension XL (13355)

Kodak Ektachem 500 XRC Analyzer

(34056)

Kodak Ektachem 700 Analyzer C Series

(34054)

Kodak Ektachem 750 XRC Analyzer

(34055)

Kodak Ektachem 950 IRC (34087)

Kodak Ektachem DT II (34057)

LSI ASCA Chemistry System (37069)

Olympus AU 5041 (46145)

ANALYTE: Alanine Aminotransferase (ALT)

(SGPT) (0404)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Abbott Spectrum CCX (04515)

Beckman Synchron CX 5 CE (07491)

Boehringer Mannheim Hitachi 914 (07546)

Du Pont ACA Star (13357)

Du Pont Dimension XL (13355)

Instrumentation Laboratory ILAB 1800

(28323)

Instrumentation Laboratory ILAB 900

(28322)

Kodak Ektachem 550 XRC Analyzer

(34056)

Kodak Ektachem 700 Analyzer C Series

(34054)

Kodak Ektachem 750 XRC Analyzer

(34055)

Kodak Ektachem 950 IRC (34087)

Kodak Ektachem DT II (34057)

LSI ASCA Chemistry System (37069)

Olympus AU 5041 (46145)

Olympus AU 5200 (46143)

PrismaSystems PROCHEM (49105)

Schiapparelli Biosystems ACE Clinical

Chemistry System (58288)

Technicon OPERA Clinical Chemistry

System (61161)

ANALYTE: Albumin (0414)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Abbott Spectrum CCX (04515)

Beckman Synchron CX 5 CE (07491)

Behring Nephelometer II (07563)

Boehringer Mannheim Hitachi 914 (07546)

Du Pont ACA Star (13357)

Du Pont Dimension XL (13355)

Instrumentation Laboratory ILAB 1800

(28323)

Instrumentation Laboratory ILAB 900

(28322)

Kodak Ektachem 550 XRC Analyzer

(34056)

Kodak Ektachem 700 Analyzer C Series

(34504)

Kodak Ektachem 750 XRC Analyzer

(34055)

Kodak Ektachem 950 IRC (34087)

Kodak Ektachem DT II (34057)

LSI ASCA Chemistry System (37069)

Olympus AU 5041 (46145)

Olympus AU 5200 (46143)

PrismaSystems PROCHEM (49105)

Schiapparelli Biosystems ACE Clinical

Chemistry System (58288)

Technicon OPERA Clinical Chemistry

System (61161)

ANALYTE: Albumin, Urinary (0516)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Du Pont ACA II (13172)

Du Pont ACA III (13173)

Du Pont ACA IV (13083)

Du Pont ACA Star (13357)

Du Pont ACA V (13084)

ANALYTE: Aldolase (0415)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Boehringer Mannheim Hitachi 914 (07546)

ANALYTE: Alkaline Phosphatase (ALP)

(0416)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Abbott Spectrum CCX (04515)

Beckman Synchron CX 5 CE (07491)

Boehringer Mannheim Hitachi 914 (07546)

Du Pont ACA Star (13357)

Du Pont Dimension XL (13355)

Instrumentation Laboratory ILAB 1800

(28323)

Instrumentation Laboratory ILAB 900

(28322)

Kodak Ektachem 550 XRC Analyzer

(34056)
25952 Federal Register / Vol. 60, No. 93 / Monday, May 15, 1995 / Notices

Kodak Ektachem 700 Analyzer C Series

(34054)

Kodak Ektachem 750 XRC Analyzer

(34055)

Kodak Ektachem 950 IRC (34087)

Kodak Ektachem DT II (34057)

LSI ASCA Chemistry System (37069)

Olympus AU 5041 (46145)

Olympus AU 5200 (46143)

PrismaSystems PROCHEM (49105)

Schiapparelli Biosystems ACE Clinical

Chemistry System (58288)

Synermed IR 500 (58322)

Technicon OPERA Clinical Chemistry

System (61161)

ANALYTE: Alpha-Hydroxybutyrate

Dehydrogenase (HBDH) (0419)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Beckman Synchron CX 5 CE (07491)

Du Pont ACA Star (13357)

ANALYTE: Ammonia, Plasma/Serum (0427)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Abbott Spectrum CCX (04515)

Abbott VP (04082)

Beckman Synchron CX 4 CE (07174)

Beckman Synchron CX 5 CE (07491)

Beckman Synchron CX 7 (07073)

Boehringer Mannheim Hitachi 911 (07377)

Boehringer Mannheim Hitachi 914 (07546)

Du Pont ACA Star (13357)

Du Pont Dimension XL (13355)

Kodak Ektachem 550 XRC Analyzer

(34056)

Kodak Ektachem 700 Analyzer C Series

(34054)

Kodak Ektachem 750 XRC Analyzer

(34055)

Kodak Ektachem 950 IRC (34087)

Kodak Ektachem DT II (34057)

ANALYTE: Amylase (0429)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Abbott Spectrum CCX (04515)

Beckman Synchron CX 5 CE (07491)

Boehringer Mannheim Hitachi 914 (07546)

Du Pont ACA Star (13357)

Du Pont Dimension XL (13355)

Instrumentation Laboratory ILAB 1800

(28323)

Instrumentation Laboratory ILAB 900

(28322)

Kodak Ektachem 550 XRC Analyzer

(34056)

Kodak Ektachem 700 Analyzer C Series

(34054)

Kodak Ektachem 750 XRC Analyzer

(34055)

Kodak Ektachem 950 IRC (34087)

Kodak Ektachem DT II (34057)

LSI ASCA Chemistry System (37069)

Olympus AU 5041 (46145)

Olympus AU 5200 (46143)

PrismaSystems PROCHEM (49105)

Schiapparelli Biosystems ACE Clinical

Chemistry System (58288)

Technicon OPERA Clinical Chemistry

System (61161)

ANALYTE: Amylase, pancreatic isoenzymes

(p-Amylase) (0500)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Beckman Synchron CX 4 (07071)

Beckman Synchron CX 5 (07072)

Boehringer Mannheim Hitachi 704 (07161)

Boehringer Mannheim Hitachi 705 (07162)

Boehringer Mannheim Hitachi 717 (07163)

Boehringer Mannheim Hitachi 747 (07166)

Boehringer Mannheim Hitachi 911 (07377)

ANALYTE: Apolipoprotein A1 (0462)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Behring Nephelometer II (07563)

Instrumentation Laboratory IL Monarch

1000 (28082)

Instrumentation Laboratory IL Monarch

2000 (28231)

Instrumentation Laboratory IL Monarch

Plus (28083)

Olympus AU 5041 (46145)

ANALYTE: Apolipoprotein B (0457)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Behring Nephelometer II (07563)

Olympus AU 5041 (46145)

ANALYTE: Aspartate Aminotransferase

(AST) (SGOT) (0405)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Abaxis EPOC 2000 (04547)

Abbott Spectrum CCX (04515)

Beckman Synchron CX 5 CE (07491)

Boehringer Mannheim Hitachi 914 (07546)

Du Pont ACA Star (13357)

Du Pont Dimension XL (13355)

Instrumentation Laboratory ILAB 1800

(28323)

Instrumentation Laboratory ILAB 900

(28322)

Kodak Ektachem 550 XRC Analyzer

(34056)

Kodak Ektachem 700 Analyzer C Series

(34054)

Kodak Ektachem 750 XRC Analyzer

(34055)

Kodak Ektachem 950 IRC (34087)

Kodak Ektachem DT II (34057)

LSI ASCA Chemistry System (37069)

Olympus AU 5041 (46145)

Olympus AU 5131 (46088)

Olympus AU 5200 (46143)

PrismaSystems PROCHEM (49105)

Schiapparelli Biosystems ACE Clinical

Chemistry System (58288)

Synermed IR 500 (58322)

Technicon OPERA Clinical Chemistry

System (61161)

ANALYTE: Bilirubin, Direct (0704)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Abbott Spectrum CCS (04515)

Beckman Synchron CX 5 CE (07491)

Boehringer Mannheim Hitachi 914 (07546)

Du Pont ACA Star (13357)

Du Pont Dimension XL (13355)

Instrumentation Laboratory ILAB 1800

(28323)

Instrumentation Laboratory ILAB 900

(28322)

Kodak Ektachem 550 XRC Analyzer

(34056)

Kodak Ektachem 700 Analyzer C Series

(34054)

Kodak Ektachem 750 XRC Analyzer

(34055)

Kodak Ektachem 950 IRC (34087)

LSI ASCA Chemistry System (37069)

Olmpus AU 5041 (46145)

Olympus AU 5200 (46143)

PrismaSystems PROCHEM (49105)

Schiapparelli Biosystems ACE Clinical

Chemistry System (58288)

Technicon OPERA Clinical Chemistry

System (61161)

ANALYTE: Bilirubin, Neonatal (0705)

TEST SYSTEM, ASSAY OR EXAMINATION:

Abbott Spectrum CCX (04515)

Du Pont ACA Star (13357)

Kodak Ektachem 550 XRC Analyzer

(34056)

Kodak Ektachem 700 Analyzer C Series

(34054)

Kodak Ektachem 750 XRC Analyzer

(34055)

Kodak Ektachem DT II (34057)

ANALYTE: Bilirubin, Total (0706)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Abaxis EPOC 2000 (04547)

Abbott Spectrum CCX (04515)

Beckman Synchron CX 5 CE (07491)

Boehringer Mannheim Hitachi 914 (07546)

Du Pont ACA Star (13357)

Du Pont Dimension XL (13355)

Instrumentation Laboratory ILAB 1800

(28323)

Instrumentation Laboratory ILAB 900

(28322)

Kodak Ektachem 550 XRC Analyzer

(34056)

Kodak Ektachem 700 Analyzer C Series

(34054)

Kodak Ektachem 750 XRC Analyzer

(34055)

Kodak Ektachem 950 IRC (34087)

Kodak Ektachem DT II (34057)

LSI ASCA Chemistry System (37069)

Olympus AU 5041 (46145)

Olympus AU 5200 (46143)

PrismaSystems PROCHEM (49105)

Schiapparelli Biosystems ACE Clinical

Chemistry System (58288)

Techicon OPERA Clinical Chemistry

System (61161)

ANALYTE: Blood Gases with pH (0708)

TEST SYSTEM, ASSAY OR

EXAMINATION:

AVL Compact 1 (04552)

AVL Compact 2 (04555)

AVL OPTI 1 (04572)

Ciba Corning 248 (10260)

Ciba Corning 840 (10250)

Ciba Corning 845 (10296)

Ciba Corning 850 (10251)

Ciba Corning 855 (10297)

Ciba Corning 860 (10269)

Ciba Corning 865 (10298)

Diametrics Medical DMI Blood Gas

Analyzer (13274)

Diametrics Medical IRMA Blood Analysis

System (13362)

I-STAT i-STAT 200 System (28344)

I-STAT i-STAT Portable Clinical Analyzer

(28186)

Instrumentation Laboratory Blood Gas

1610 (28335)

Instrumentation Laboratory Blood Gas

1620 (28336)

Instrumentation Laboratory Blood Gas

1630 (28337)

Instumentation Laboratory Blood Gas 1640

(28338)

Instrumentation Laboratory Blood Gas

1650 (28339)
Federal Register / Vol. 60, No. 93 / Monday, May 15, 1995 / Notices 25953

Instrumentation Laboratory IL 1430

BGElectrolyte (28343)

Nova Stat profile 7 (43035)

Nova Stat Profile 9 (43086)

Nova Stat Profile Plus 10 (43063)

Nova Stat Profile Ultra 11P Analyzer

(43101)

PPG Industries StatPal II Blood Gas

Analysis System (49092)

Radiometer ABL 5 (55136)

Radiometer ABL 620 (55137)

ANALYTE: Blood pH (no blood gases)

(07221)

TEST SYSTEM, ASSAY OR

EXAMINATION:

AVL 9110 pH Analyzer (04523)

AVL 988–4 (04556)

Ionetics Model 400/450 Electrolyte

Analyzer (28324)

Medica EasyLyte Calcium Analyzer

(40197)

ANALYTE: Calcium, Ionized (1004)

TEST SYSTEM, ASSAY OR

EXAMINATION:

AVL 988–4 (04556)

Ciba Corning 850 (10251)

Ciba Corning 855 (10297)

Ciba Corning 860 (10269)

Ciba Corning 865 (10298)

Diametrics Medical IRMA Blood Analysis

System (13362)

I-STAT i-STAT 200 System (28344)

I-STAT i-STAT Portable Clinical Analyzer

(28186)

Instrumentation Laboratory Blood Gas

1640 (28338)

Ionetics Model 400/450 Electrolyte

Analyzer (28324)

Medica EasyLyte Calcium Analyzer

(40197)

Nova Stat Profile 9 (43086)

Nova Stat Profile Ultra 11P Analyzer

(43101)

Radiometer ABL 620 (55137)

Radiometer EML 100 (55134)

ANALYTE: Calcium, Total (1005)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Abbott Spectrum CCX (04515)

Beckman Synchron AS–X (07069)

Beckman Synchron CX 3 Delta (07548)

Beckman Synchron CX 5 CE (07491)

Boehringer Mannheim Hitachi 914 (07546)

Du Pont ACA Star (13357)

Du Pont Dimension XL (13355)

Instrumentation Laboratory ILAB 1800

(28323)

Instrumentation Laboratory ILAB 900

(28322)

Kodak Ektachem 550 XRC Analyzer

(34056)

Kodak Ektachem 700 Analyzer C Series

(34054)

Kodak Ektachem 750 XRC Analyzer

(34055)

Kodak Ektachem 950 IRC (34087)

Kodak Ektachem DT II (34057)

LSI ASCA Chemistry System (37069)

Nova 10 (with CRT) (43061)

Olympus AU 5041 (46145)

Olympus AU 5200 (46143)

PrismaSystems PROCHEM (49105)

Schiapparelli Biosystems ACE Clinical

Chemistry System (58288)

Synermed IR 500 (58322)

Technicon OPERA Clinical Chemistry

System (61161)

ANALYTE: Carbon Dioxide, Total (CO2)

(1003)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Abbott Spectrum CCX (04515)

Beckman Synchron CX 3 Delta (07548)

Beckman Synchron CX 5 CE (07491)

Boehringer Mannheim Hitachi 914 (07546)

Du Pont ACA Star (13357)

Du Pont Dimension XL (13355)

Kodak Ektachem 550 XRC Analyzer

(34056)

Kodak Ektachem 700 Analyzer C Series

(34054)

Kodak Ektachem 750 XRC Analyzer

(34055)

Kodak Ektachem 950 IRC (34087)

Kodak Ektachem DT II (34057)

LSI ASCA Chemistry System (37069)

Nova 16 (43103)

Olympus AU 5041 (46145)

Olympus AU 5121 (46087)

Olympus AU 5200 (46143)

Schiapparelli Biosystems ACE Clinical

Chemistry System (58288)

Technicon OPERA Clinical Chemistry

System (61161)

ANALYTE: Carcinoembryonic Antigen (CEA)

(1013)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Boehringer Mannheim ES 300 (07160)

TOSOH A1A–600 (61039)

ANALYTE: Cerebrospinal Fluid (CSF)

Protein (1014)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Beckman Synchron CX 4 (07071)

Beckman Synchron CX 4 CE (07174)

Beckman Synchron CX 5 (07072)

Beckman Synchron CX 7 (07073)

Boehringer Mannheim Hitachi 704 (07161)

Boehringer Mannheim Hitachi 717 (07163)

Boehringer Mannheim Hitachi 747 (07166)

Boehringer Mannheim Hitachi 911 (07377)

Du Pont ACA Star (13357)

Du Pont Dimension (13086)

Du Pont Dimension AR (13087)

Du Pont Dimension ES (13215)

Du Pont Dimension XL (13355)

Kodak Ektachem 550 XRC Analyzer

(34056)

Kodak Ektachem 700 Analyzer C Series

(34054)

Kodak Ektachem 750 XRC Analyzer

(34055)

Kodak Ektachem 950 IRC (34087)

ANALYTE: Ceruloplasmin (1015)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Behring Nephelometer II (07563)

ANALYTE: Chloride (1018)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Beckman Synchron CX 3 Delta (07548)

Beckman Synchron CX 5 CE (07491)

Boehringer Mannheim Hitachi 914 (07546)

Ciba Corning 850 (10251)

Ciba Corning 855 (10297)

Ciba Corning 860 (10269)

Ciba Corning 865 (10298)

Du Pont ACA Star (13357)

Du Pont Dimension XL (13355)

I–STAT i–STAT 200 System (28344)

Instrumentation Laboratory Blood Gas

1650 (28339)

Instrumentation Laboratory IL 1430

BGElectrolyte (28343)

Instrumentation Laboratory ILAB 1800

(28323)

Instrumentation Laboratory ILAB 900

(28322)

Instrumentation Laboratory ILyte Na, K, C1

System (28320)

Ionetics Model 400/450 Electrolyte

Analyzer (28324)

Kodak Ektachem 550 XRC Analyzer

(34056)

Kodak Ektachem 700 Analyzer C Series

(34054)

Kodak Ektachem 750 XRC Analyzer

(34055)

Kodak Ektachem 950 IRC (34087)

Kodak Ektachem DT II (34057)

LSI ASCA Chemistry System (37069)

Nova 10 (with CRT) (43061)

Nova 16 (43103)

Nova Stat Profile 9 (43086)

Nova Stat Profile Plus 10 (43063)

Olympus AU 5041 (46145)

Olympus AU 5200 (46143)

PrismaSystems PROCHEM (49105)

Radiometer ABL 620 (55137)

Radiometer EML 100 (55134)

Schiapparelli Biosystems ACE Clinical

Chemistry System (58288)

Synermed IR 500 (58322)

Technicon OPERA Clinical Chemistry

System (61161)

ANALYTE: Chloride, Sweat (Cystic Fibrosis

Sweat Test) (1019)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Scandipharm CF Indicator (9800) (58240)

ANALYTE: Cholesterol (1020)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Abbott Spectrum CCX (04515)

Beckman Synchron CX 5 CE (07491)

Boehringer Mannheim Hitachi 914 (07546)

Du Pont ACA Star (13357)

Du Pont Dimension XL (13355)

Instrumentation Laboratory ILAB 1800

(28323)

Instrumentation Laboratory ILAB 900

(28322)

Kodak Ektachem 550 XRC Analyzer

(34056)

Kodak Ektachem 700 Analyzer C Series

(34054)

Kodak Ektachem 750 XRC Analyzer

(34055)

Kodak Ektachem 950 IRC (34087)

Kodak Ektachem DT II (34057)

LSI ASCA Chemistry System (37069)

Olympus AU 5041 (46145)

Olympus AU 5200 (46143)

PrismaSystems PROCHEM (49105)

Schiapparelli Biosystems ACE Clinical

Chemistry System (58288)

StatChem StatTest Sysem (58269)

Technicon OPERA Clinical Chemistry

System (61161)

ANALYTE: Cholinesterase (1021)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Beckman Synchron CX 5 CE (07491)

Boehringer Mannheim Hitachi 911 (07377)

Boehringer Mannheim Hitachi 914 (07546)
25954 Federal Register / Vol. 60, No. 93 / Monday, May 15, 1995 / Notices

Kodak Ektachem 550 XRC Analyzer

(34056)

Kodak Ektachem 700 Analyzer C Series

(34054)

Kodak Ektachem 750 XRC Analyzer

(34055)

Kodak Ektachem 950 IRC (34087)

Kodak Ektachem DT II (34057)

Technicon Chem 1 (61003)

Technicon Chem 1 Plus (61036)

ANALYTE: Creatine Kinase (CK) (1034)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Abbott Spectrum CCX (04515)

Beckman Synchron CX 5 CE (07491)

Boehringer Mannheim Hitachi 914 (07546)

Du Pont ACA Star (13357)

Du Pont Dimension XL (13355)

Instrumentation Laboratory ILAB 1800

(28323)

Instrumentation Laboratory ILAB 900

(28322)

Kodak Ektachem 550 XRC Analyzer

(34056)

Kodak Ektachem 700 Analyzer C Series

(34054)

Kodak Ektachem 750 XRC Analyzer

(34055)

Kodak Ektachem 950 IRC (34087)

Kodak Ektachem DT II (34057)

LSI ASCA Chemistry System (37069)

Olympus AU 5041 (46145)

Olympus AU 5121 (46087)

Olympus AU 5200 (46143)

PB Diagnostics Systems OPUS (49001)

PB Diagnostics Systems OPUS Magnum

(49097)

PB Diagnostics Systems OPUS PLUS

(49098)

Schiapparelli Biosystems ACE Clinical

Chemistry System (58288)

Technicon OPERA Clinical Chemistry

System (61161)

ANALYTE: Creatine Kinase MB Fraction

(CKMB) (1002)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Abbott AxSYM (04532)

Beckman Synchron CX 5 CE (07491)

Boehringer Mannheim Hitachi 914 (07546)

Du Pont ACA Star (13357)

Du Pont ACA Star with aca plus

Immunoassay System (13358)

Du Pont Dimension XL (13355)

Kodak Ektachem 550 XRC Analyzer

(34056)

Kodak Ektachem 700 Analyzer C Series

(34054)

Kodak Ektachem 750 XRC Analyzer

(34055)

Kodak Ektachem 950 IRC (34087)

Kodak Ektachem DT II 34057)

LSI ASCA Chemistry System (37069)

PB Diagnostics Systems OPUS Magnum

(49097)

PB Diagnostics Systems OPUS PLUS

(49098)

Princeton BioMeditech AccuSign MI CK–

MB/Myoglobin (49143)

Princeton BioMeditech CarePoint MI CK–

MB/Myoglobin (49141)

Princeton BioMeditech LifeSign MI CK–

MB/Myoglobin (49140)

Princeton BioMeditech VitalSign MI CK–

MB/Myoglobin (49142)

Sanofi Pasteur Access Immunoassay

System (58257)

ANALYTE: Creatinine (1035)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Abbott Spectrum CCX (04515)

Beckman Synchron CX 3 Delta (07548)

Boehringer Mannheim Hitachi 914 (07546)

Du Pont ACA Star (13357)

Du Pont Dimension XL (13355)

Instrumentation Laboratory ILAB 1800

(28323)

Instrumentation Laboratory ILAB 900

(28322)

Kodak Ektachem 550 XRC Analyzer

(34056)

Kodak Ektachem 700 Analyzer C Series

(34054)

Kodak Ektachem 750 XRC Analyzer

(34055)

Kodak Ektachem 950 IRC (34087)

Kodak Ektachem DT II (34057)

LSI ASCA Chemistry System (37069)

Nova 16 (43103)

Olympus AU 5041 (46145)

Olympus AU 5121 (46087)

Olympus AU 5200 (46143)

PrismaSystems PROCHEM (49105)

Schiapparelli Biosystems ACE Clinical

Chemistry System (58288)

Synermed IR 500 (58322)

Technicon OPERA Clinical Chemistry

System (61161)

ANALYTE: Ferritin (1902)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Abbott AxSYM (04532)

Bio-Rad RADIAS System (07493)

Boehringer Mannheim ES 300 AL (07524)

Cirrus Diagnostics Immulite (10159)

Du Pont ACA III with aca plus

Immunoassay System (13253)

Du Pont ACA IV with aca plus

Immunoassay System (13254)

Du Pont ACA Star with aca plus

Immunoassay System (13358)

Du Pont ACA V with aca plus

Immunoassay System (13255)

Olympus Reply (46089)

PB Diagnostics Systems OPUS Magnum

(49097)

PB Diagnostics Systems OPUS PLUS

(49098)

Roche Cobas Core (55119)

Roche Cobas FARA (55040)

Roche Cobas FARA II (55041)

Roche Cobas Mira Plus (55096)

Sanofi Pasteur Access Immunoassay

System (58257)

Seradyn LPIA–100 (58294)

Syva Vista Immunoassay System (58221)

Vitek Systems Vidas (67038)

ANALYTE: Folate (Folic acid) (1907)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Bio-Rad RADIAS System (07493)

Boehringer Mannheim Hitachi 911 (07377)

Cirrus Diagnostics Immulite (10159)

Roche Cobas Mira Plus (55096)

Sanofi Pasteur Access Immunoassay

System (58257)

Syva Vista Immunoassay System (58221)

ANALYTE: Folate, Red Blood Cell (RBC

Folate) (1930)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Ciba Corning ACS 180 (10046)

Sanofi Pasteur Access Immunoassay

System (58257)

ANALYTE: Fructosamine (1914)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Boehringer Mannheim Hitachi 736 (07164)

Boehringer Mannheim Hitachi 914 (07546)

ANALYTE: Gamma Glutamyl Transferase

(GGT) (2201)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Abbott Spectrum CCX (04515)

Beckman Synchron CX 5 CE (07491)

Boehringer Mannheim Hitachi 914 (07546)

Du Pont ACA Star (13357)

Du Pont Dimension XL (13355)

Instrumentation Laboratory ILAB 1800

(28323)

Instrumentation Laboratory ILAB 900

(28322)

Kodak Ektachem 550 XRC Analyzer

(34056)

Kodak Ektachem 700 Analyzer C Series

(34054)

Kodak Ektachem 750 XRC Analyzer

(34055)

Kodak Ektachem 950 IRC (34087)

Kodak Ektachem DT II (34057)

LSI ASCA Chemistry System (37069)

Olympus AU 5041 (46145)

Olympus AU 5200 (46143)

PrismaSystems PROCHEM (49105)

Schiapparelli Biosystems ACE Clinical

Chemistry System (58288)

Technicon OPERA Clinical Chemistry

System (61161)

ANALYTE: Glucose (2203)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Abaxis EPOC 2000 (04547)

Abbott Spectrum CCX (04515)

Beckman Synchron CX 3 Delta (07548)

Beckman Synchron CX 5 CE (07491)

Boehringer Mannheim Hitachi 914 (07546)

Cholestech L.D.X. (10170)

Ciba Corning 860 (10269)

Ciba Corning 865 (10298)

Du Pont ACA Star (13357)

Du Pont Dimension XL (13355)

I–STAT i–STAT 200 System (28344)

Instrumentation Laboratory ILAB 1800

(28323)

Instrumentation Laboratory ILAB 900

(28322)

Kodak Ektachem 550 XRC Analyzer

(34056)

Kodak Ektachem 700 Analyzer C Series

(34054)

Kodak Ektachem 750 XRC Analyzer

(34055)

Kodak Ektachem 950 IRC (34087)

Kodak Ektachem DT II (34057)

LSI ASCA Chemistry System (37069)

Nova 16 (43103)

Nova Stat Profile 9 (43086)

Nova Stat Profile Plus 10 (43063)

Nova Stat Profile Ultra 11P Analyzer

(43101)

Olympus AU 5041 (46145)

Olympus AU 5121 (46087)

Olympus AU 5200 (46143)

PrismaSystems PROCHEM (49105)

Schiapparelli Biosystems ACE Clinical

Chemistry System (58288)

StatChem StatTest System (58269)
Federal Register / Vol. 60, No. 93 / Monday, May 15, 1995 / Notices 25955

Synermed IR 500 (58322)

Technicon OPERA Clinical Chemistry

System (61161)

Yellow Springs YSI Model 23A Blood

Glucose Analyzer (76006)

ANALYTE: Glycosylated Hemoglobin (Hgb

A1C) (2204)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Abbott IMX (04056)

Beckman Synchron CX 4 (07071)

Beckman Synchron CX 5 (07072)

Beckman Synchron CX 7 (07073)

Bio-Rad RADIAS System (07493)

Bio-Rad Variant (07498)

Boehringer Mannheim Hitachi 704 (07161)

Boehringer Mannheim Hitachi 717 (07163)

Boehringer Mannheim Hitachi 747 (07166)

Boehringer Mannheim Hitachi 911 (07377)

Boehringer Mannheim Hitachi 914 (07546)

Roche Cobas FARA (55040)

Roche Cobas Mira (55044)

ANALYTE: HDL Cholesterol (2550)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Abbott Spectrum (DMA One Shots) (04598)

Abbott Spectrum (MHS SPINPRO) (04563)

Abbott Spectrum (T-Am. Singles) (04588)

Abbott Spectrum CCX (DMA One Shots)

(04599)

Abbott Spectrum CCX (T-Am. Singles)

(04587)

Abbott Spectrum EPX (DMA One Shots)

(04600)

Abbott Spectrum EPX (MHS SPINPRO)

(04564)

Abbott Spectrum EPX (T-Am. Singles)

(04565)

Abbott Spectrum Series II (DMA One

Shots) (04601)

Abbott Spectrum Series II (MHS SPINPRO)

(04566)

Abbott Spectrum Series II (T-Am. Singles)

(04589)

Abbott Spectrum Series II CCX (DMA One

Shots) (04602)

Abbott Spectrum Series II CCX (MHS

SPINPRO) (04567)

Abbott Spectrum Series II CCX (T-Am.

Singles) (04590)

Abbott TDX (04071)

Abbott TDX (MHS SPINPRO) (04568)

Abbott TDX FLx (04072)

Abbott TDX FLx (MHS SPINPRO) (04569)

Abbott VP (DMA One Shots) (04603)

Abbott VP (MHS SPINPRO) (04570)

Abbott Vision, Non Whole Blood HDL

Procedure (04451)

Abbott Vision, Non Whole Blood HDL

Procedure (MHS SPINPRO) (04571)

Ames Seralyzer (DMA One Shots) (04604)

Ames Seralyzer III (DMA One Shots)

(04605)

Baxter Paramax (DMA One Shots) (07618)

Baxter Paramax (MHS SPINPRO) (07566)

Baxter Paramax 720 ZX (DMA One Shots)

(07619)

Baxter Paramax 720 ZX (MHS SPINPRO)

(07567)

Beckman Astra 8 (MHS SPINPRO) (07568)

Beckman Astra 8e (MHS SPINPRO) (07569)

Beckman Astra Ideal (MHS SPINPRO)

(07570)

Beckman Synchron AS–X (MHS SPINPRO)

(07571)

Beckman Synchron AS–Xe (MHS

SPINPRO) (07572)

Beckman Synchron AS Xi (MHS SPINPRO)

(07573)

Beckman Synchron CX 4 (DMA One Shots)

(07620)

Beckman Synchron CX 4 (MHS SPINPRO)

(07574)

Beckman Synchron CX 4 CE (DMA One

Shots) (07621)

Beckman Synchron CX 4 CE (MHS

SPINPRO) (07575)

Beckman Synchron CX 5 (DMA One Shots)

(07622)

Beckman Synchron CX 5 (MHS SPINPRO)

(07576)

Beckman Synchron CX 5 (T-Am. Singles)

(07577)

Beckman Synchron CX 5 CE (DMA One

Shots) (07623)

Beckman Synchron CX 7 (DMA One Shots)

(07624)

Beckman Synchron CX 7 (MHS SPINPRO)

(07578)

Beckman Synchron CX 7 (T-Am. Singles)

(07579)

Bio-Chem Laboratory Systems ATAC 2000/

2100 (DMA One Shots) (07634)

Bio-Chem Laboratory Systems ATAC 6000

(DMA One Shots) (07626)

Bio-Chem Laboratory Systems ATAC 6000

(T-Am. Singles) (07596)

BioAutoMed ASCA (07192)

BioAutoMed ASCA (DMA One Shots)

(07625)

Boehringer Mannheim Hitachi 704 (DMA

One Shots) (07627)

Boehringer Mannheim Hitachi 704 (MHS

SPINPRO) (07580)

Boehringer Mannheim Hitachi 704 (T-Am.

Singles) (07590)

Boehringer Mannheim Hitachi 705 (DMA

One Shots) (07628)

Boehringer Mannheim Hitachi 705 (MHS

SPINPRO) (07581)

Boehringer Mannheim Hitachi 705 (T-Am.

Singles) (07591)

Boehringer Mannheim Hitachi 717 (DMA

One Shots) (07629)

Boehringer Mannheim Hitachi 717 (MHS

SPINPRO) (07582)

Boehringer Mannheim Hitachi 717 (T-Am.

Singles) (07592)

Boehringer Mannheim Hitachi 736 (DMA

One Shots) (07630)

Boehringer Mannheim Hitachi 736 (MHS

SPINPRO) (07583)

Boehringer Mannheim Hitachi 736 (T-Am.

Singles) (07593)

Boehringer Mannheim Hitachi 737 (DMA

One Shots) (07631)

Boehringer Mannheim Hitachi 737 (MHS

SPINPRO) (07584)

Boehringer Mannheim Hitachi 737 (T-Am.

Singles) (07594)

Boehringer Mannheim Hitachi 747 (DMA

One Shots) (07632)

Boehringer Mannheim Hitachi 747 (MHS

SPINPRO) (07585)

Boehringer Mannheim Hitachi 747 (T-Am.

Singles) (07595)

Boehringer Mannheim Hitachi 911 (MHS

SPINPRO) (07586)

Ciba Corning 550 Express (DMA One

Shots) (10291)

Ciba Corning 550 Express (MHS SPINPRO)

(10274)

Ciba Corning 550 Express (T-Am. Singles)

(10273)

Ciba Corning 570 Alliance (MHS

SPINPRO) (10275)

Ciba Corning 580 Alliance (MHS

SPINPRO) (10276)

Coulter Dacos (DMA One Shots) (10292)

Coulter Dacos (T-Am. Singles) (10277)

Coulter Optichem (T-Am. Singles) (10278)

Coulter Optichem 100 (DMA One Shots)

(10293)

Du Pont ACA (DMA One Shots) (13365)

Du Pont ACA (MHS SPINPRO) (13346)

Du Pont ACA II (DMA One Shots) (13366)

Du Pont ACA II (MHS SPINPRO) (13347)

Du Pont ACA III (DMA One Shots) (13367)

Du Pont ACA III (MHS SPINPRO) (13348)

Du Pont ACA IV (DMA One Shots) (13368)

Du Pont ACA IV (MHS SPINPRO) (13349)

Du Pont ACA V (DMA One Shots) (13369)

Du Pont ACA V ((MHS SPINPRO) (13350)

Du Pont Analyst (DMA One Shots) (13364)

Du Pont Analyst (MHS SPINPRO) (13351)

Du Pont Dimension (DMA One Shots)

(13370)

Du Pont Dimension (MHS SPINPRO)

(13352)

Du Pont Dimension AR (DMA One Shots)

(13371)

Du Pont Dimension AR (MHS SPINPRO)

(13353)

Du Pont Dimension ES (DMA One Shots)

(13372)

Du Pont Dimension ES (MHS SPINPRO)

(13354)

EM Diagnostic Systems EPOS (DMA One

Shots) (16099)

EM Diagnostic Systems EPOS (MHS

SPINPRO) (16094)

Electronucleonics Gem-Profiler (DMA One

Shots) (16095)

Electronucleonics Gemini (DMA One

Shots) (16096)

Electronucleonics Gemstar (DMA One

Shots) (16097)

Electronucleonics Gemstar (T-Am. Singles)

(16093)

Electronucleonics Gemstar II (DMA One

Shots) (16098)

Instrumentation Laboratory IL Monarch (TAm. Singles) (28361)

Instrumentation Laboratory IL Monarch

1000 (DMA One Shots) (28380)

Instrumentation Laboratory IL Monarch

1000 (T-Am. Singles) (28362)

Instrumentation Laboratory IL Monarch

2000 (DMA One Shots) (28381)

Instrumentation Laboratory IL Monarch

2000 (T-Am. Singles) (28363)

Instrumentation Laboratory IL Monarch

Plus (DMA One Shots) (28382)

Instrumentation Laboratory IL Monarch

Plus (T-Am. Singles) (28364)

Kodak Ektachem 250 (DMA One Shots)

(34076)

Kodak Ektachem 250 (MHS SPINPRO)

(34063)

Kodak Ektachem 400 (DMA One Shots)

(34077)

Kodak Ektachem 400 (MHS SPINPRO)

(34064)

Kodak Ektachem 500 (DMA One Shots)

(34078)

Kodak Ektachem 500 (MHS SPINPRO)

(34065)

Kodak Ektachem 550 XRC Analyzer

(34056)

Kodak Ektachem 550 XRC Analyzer (DMA

One Shots) (34079)
25956 Federal Register / Vol. 60, No. 93 / Monday, May 15, 1995 / Notices

Kodak Ektachem 700 (DMA One Shots)

(34080)

Kodak Ektachem 700 (MHS SPINPRO)

(34066)

Kodak Ektachem 700 Analyzer C Series

(34054)

Kodak Ektachem 700 Analyzer C Series

(DMA One Shots) (34081)

Kodak Ektachem 700 P (DMA One Shots)

(34082)

Kodak Ektachem 700 P (MHS SPINPRO)

(34067)

Kodak Ektachem 700 XR (DMA One Shots)

(34083)

Kodak Ektachem 700 XR (MHS SPINPRO)

(34068)

Kodak Ektachem 750 XRC (DMA One

Shots) (34084)

Kodak Ektachem 750 XRC Analyzer

(34055)

Kodak Ektachem 950 IRC (34087)

Kodak Ektachem DT 60 (DMA One Shots)

(34085)

Kodak Ektachem DT 60 (MHS SPINPRO)

(34069)

Kodak Ektachem DT II (34057)

Kodak Ektachem DT II (DMA One Shots)

(34086)

LSI ASCA Chemistry System (37069)

LSI ASCA Chemistry System (DMA One

Shots) (37096)

LSI ASCA Chemistry System (T-Am.

Singles) (37095)

Olympus AU 5000 (DMA One Shots)

(46173)

Olympus AU 5021 (DMA One Shots)

(46174)

Olympus AU 5031 (DMA One Shots)

(46175)

Olympus AU 5041 (DMA One Shots)

(46176)

Olympus AU 5061 (DMA One Shots)

(46177)

Olympus AU 5121 (DMA One Shots)

(46178)

Olympus AU 5131 (DMA One Shots)

(46179)

Olympus AU 5200 (DMA One Shots)

(46180)

Olympus AU 5211 (DMA One Shots)

(46181)

Olympus AU 5221 (DMA One Shots)

(46182)

Olympus AU 5223 (DMA One Shots)

(46183)

Olympus AU 5231 (DMA One Shots)

(46184)

Olympus AU 800 (DMA One Shots)

(46185)

Olympus AU 5000 (MHS SPINPRO)

(46161)

Olympus AU 5000 (T-Am. Singles) (46166)

Olympus Demand (DMA One Shots)

(46186)

Olympus Demand (MHS SPINPRO) (46162)

Olympus Demand (T–Am. Singles) (46164)

Olympus Reply (DMA One Shots) (46187)

Olympus Reply (MHS SPINPRO) (46163)

Olympus Reply (T–Am. Singles) (46165)

Olympus Reply/AU560 (DMA One Shots)

(46188)

PrismaSystems PROCHEM (49105)

Roche Cobas Bio (DMA One Shots) (55152)

Roche Cobas Bio (MHS SPINPRO) (55140)

Roche Cobas Bio (T–Am. Singles) (55143)

Roche Cobas FARA (DMA One Shots)

(55153)

Roche Cobas FARA II (DMA One Shots)

(55154)

Roche Cobas Fara (MHS SPINPRO) (55141)

Roche Cobas Fara (T–Am. Singles) (55144)

Roche Cobas MIRA (DMA One Shots)

(55155)

Roche Cobas MIRA Plus (DMA One Shots)

(55156)

Roche Cobas MIRA S (DMA One Shots)

(55157)

Roche Cobas Mira (MHS SPINPRO) (55142)

Roche Cobas Mira (T–Am. Singles) (55145)

Schiapparelli Biosystems ACE (DMA One

Shots) (58357)

Schiapparelli Biosystems ACE Clinical

Chemistry System (58288)

Technicon Assist (DMA One Shots)

(61181)

Technicon RA 100 (DMA One Shots)

(61182)

Technicon RA 1000 (DMA One Shots)

(61183)

Technicon RA 1000 (MHS SPINPRO)

(61162)

Technicon RA 1000 (T–Am. Singles)

(61164)

Technicon RA 2000 (DMA One Shots)

(61184)

Technicon RA 500 (DMA One Shots)

(61185)

Technicon RA 500 (T–Am. Singles) (61163)

Technicon RA XT (DMA One Shots)

(61186)

Technicon RA XT (T–Am. Singles) (61165)

ANALYTE: Haptoglobin (2511)

TEST SYSTEM, ASSAY OR

EXAMINATION

Behring Nephelometer II (07563)

ANALYTE: Hemoglobin S (2536)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Histo-Med Sickle Cell Reagent Set (25164)

ANALYTE: Iron (2814)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Abbott Spectrum CCX (04515)

Beckman Synchron CX 5 CE (07491)

Boehringer Mannheim Hitachi 914 (07546)

Du Pont ACA Star (13357)

Du Pont Dimension XL (13355)

Instrumentation Laboratory ILAB 1800

(28323)

Instrumentation Laboratory ILAB 900

(28322)

Kodak Ektachem 550 XRC Analyzer

(34056)

Kodak Ektachem 700 Analyzer C Series

(34054)

Kodak Ektachem 750 XRC Analyzer

(34055)

Kodak Ektachem 950 IRC (34087)

Kodak Ektachem DT SC Module (34017)

LSI ASCA Chemistry System (37069)

Olympus AU 5041 (46145)

Olympus AU 5200 (46143)

PrismaSystems PROCHEM (49105)

Schiapparelli Biosystems ACE Clinical

Chemistry System (58288)

Technicon OPERA Clinical Chemistry

System (61161)

ANALYTE: Iron Binding Capacity, Unsat.

(UIBC) no pretreat. (2823)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Boehringer Mannheim Hitachi 914 (07546)

ANALYTE: Lactate Dehydrogenase (LDH)

(3701)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Abbott Spectrum CCX (04515)

Beckman Synchron CX 5 CE (07491)

Boehringer Mannheim Hitachi 914 (07546)

Du Pont ACA Star (13357)

Du Pont Dimension XL (13355)

Kodak Ektachem 550 XRC Analyzer

(34056)

Kodak Ektachem 700 Analyzer C Series

(34054)

Kodak Ektachem 750 XRC Analyzer

(34055)

Kodak Ektachem 950 IRC (34087)

Kodak Ektachem DT II (34057)

LSI ASCA Chemistry System (37069)

Olympus AU 5041 (46145)

Olympus AU 5121 (46087)

Olympus AU 5200 (46143)

PrismaSystems PROCHEM (49105)

Schiapparelli Biosystems ACE Clinical

Chemistry System (58288)

Synermed IR 500 (58322)

Technicon OPERA Clinical Chemistry

System (61161)

ANALYTE: Lactate Dehydrogenase Heart

Fraction (LDH–1) (3702)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Abbott Spectrum CCX (04515)

Boehringer Mannheim Hitachi 914 (07546)

Du Pont ACA Star (13357)

ANALYTE: Lactate Dehydrogenase Liver

Fraction (LLDH) 3703)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Du Pont ACA Star (13357)

Instrumentation Laboratory ILAB 1800

(28323)

Instrumentation Laboratory ILAB 900

(28322)

ANALYTE: Lactic Acid (Lactate) (3704)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Beckman Synchron CX 5 CE (07491)

Boehringer Mannheim Hitachi 914 (07546)

Ciba Corning 860 (10269)

Ciba Corning 865 (10298)

Du Pont ACA Star (13357)

Du Pont Dimension XL (13355)

Kodak Ektachem 550 XRC Analyzer

(34056)

Kodak Ektachem 700 Analyzer C Series

(34054)

Kodak Ektachem 750 XRC Analyzer

(34055)

Kodak Ektachem 950 IRC (34087)

Kodak Ektachem DT II (34057)

Nova Stat Profile 9 (43086)

Nova Stat Profile Plus 10 (43063)

Nova Stat Profile Ultra 11P Analyzer

(43101)

Technicon OPERA Clinical Chemistry

System (61161)

Yellow Springs YSI Model 23L Blood

Lactoat Analyzer (76007)

ANALYTE: Lactoferrin (3727)

TEST SYSTEM, ASSAY OR

EXAMINATION:

TechLab LEUKO–TEST (61133)

Touch Scientific LactoCard Tear

Lactoferrin Immunoassay (61110)
Federal Register / Vol. 60, No. 93 / Monday, May 15, 1995 / Notices 25957

Touch Scientific Lactoferrin MicroAssay

System (61137)

ANALYTE: Leucine Aminopeptidase (LAP)

(3709)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Beckman Synchron CX 5 CE (07491)

ANALYTE: Lipase (3711)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Boehringer Mannheim Hitachi 914 (07546)

Du Pont ACA Star (13357)

Du Pont Dimension XL (13355)

Kodak Ektachem 550 XRC Analyzer

(34056)

Kodak Ektachem 700 Analyzer C Series

(34054)

Kodak Ektachem 750 XRC Analyzer

(34055)

Kodak Ektachem 950 IRC (34087)

Kodak Ektachem DT 60 (34016)

Kodak Ektachem DT II (34057)

LSI ASCA Chemistry System (37069)

Olympus AU 5041 (46145)

ANALYTE: Magnesium (4002)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Abbott Spectrum CCX (04515)

Beckman Synchron CX 5 CE (07491)

Boehringer Mannheim Hitachi 914 (07546)

Du Pont ACA Star (13357)

Du Pont Dimension XL (13355)

Instrumentation Laboratory ILAB 1800

(28323)

Instrumentation Laboratory ILAB 900

(28322)

Kodak Ektachem 550 XRC Analyzer

(34056)

Kodak Ektachem 700 Analyzer C Series

(34054)

Kodak Ektachem 750 XRC Analyzer

(34055)

Kodak Ektachem 950 IRC (34087)

Kodak Ektachem DT II (34057)

LSI ASCA Chemistry System (37069)

Nova 8 (43022)

Olympus AU 5041 (46145)

Olympus AU 5121 (46087)

Olympus AU 5200 (46143)

PrismaSystems PROCHEM (49105)

Schiapparelli Biosystems ACE Clinical

Chemistry System (58288)

Technicon Chem 1 Plus (61036)

Technicon OPERA Clinical Chemistry

System (61161)

ANALYTE: Magnesium, Ionized (4018)

TEST SYSTEM, ASSAY OR

EXAMINATION:

AVL 988–4 (04556)

Nova Stat Profile Ultra 11P Analyzer

(43101)

ANALYTE: Methemoglobin (4032)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Ciba Corning 845 (10296)

Ciba Corning 855 (10297)

Ciba Corning 865 (10298)

ANALYTE: Microalbumin (4019)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Boehringer Mannheim Hitachi 747 (07166)

Boehringer Mannheim Hitachi 911 (07377)

ANALYTE: Microprotein, CSF (4026)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Beckman Synchron CX 4 CE (07174)

Beckman Synchron CX 5 CE (07491)

Beckman Synchron CX 7 (07073)

Boehringer Mannheim Hitachi 914 (07546)

Olympus AU 5041 (46145)

Olympus AU 800 (46110)

ANALYTE: Microprotein, Urine (4027)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Beckman Synchron CX 4 CE (07174)

Beckman Synchron CX 5 CE (07491)

Beckman Synchron CX 7 (07073)

Boehringer Mannheim Hitachi 914 (07546)

Olympus AU 5041 (46145)

Olympus AU 800 (46110)

ANALYTE: Myoglobin (4023)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Behring Nephelometer II (07563)

PB Diagnostics Systems OPUS Magnum

(49097)

PB Diagnostics Systems OPUS PLUS

(49098)

Princeton BioMeditech AccuSign MI CK–

MB/Myoglobin (49143)

Princeton BioMeditech CarePoint MI CK–

MB/Myoglobin (49141)

Princeton BioMeditech LifeSign MI CK–

MB/Myoglobin (49140)

Princeton BioMeditech LifeSign MI

Myoglobin (49122)

Princeton BioMeditech VitalSign MI CK–

MB/Myoglobin (49142)

ANALYTE: Osmolality, Serum (4602)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Advanced Instruments Model 3D3

Osmometer (04520)

ANALYTE: Osmolality, Urine (4603)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Advanced Instruments Model 3D3

Osmometer (04520)

ANALYTE: Oxyhemoglobin/Oxygen

Saturation (4604)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Ciba Corning 845 (10296)

Ciba Corning 855 (10297)

Ciba Corning 865 (10298)

Radiometer ABL 620 (55137)

ANALYTE: Phosphorus (4906)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Abbott Spectrum CCX (04515)

Beckman Synchron CX 5 CE (07491)

Boehringer Mannheim Hitachi 914 (07546)

Du Pont ACA Star (13357)

Du Pont ACA Dimension XL (13355)

Instrumentation Laboratory ILAB 1800

(28323)

Instrumentation Laboratory ILAB 900

(28322)

Kodak Ektachem 550 XRC Analyzer

(34056)

Kodak Ektachem 700 Analyzer C Series

(34054)

Kodak Ektachem 750 XRC Analyzer

(34055)

Kodak Ektachem 950 IRC (34087)

Kodak Ektachem DT II (34057)

LSI ASCA Chemistry System (37069)

Olympus AU 5041 (46145)

Olympus AU 5121 (46087)

Olympus AU 5200 (46143)

PrismaSystems PROCHEM (49105)

Schiapparelli Biosystems ACE Clinical

Chemistry System (58288)

Synermed IR 500 (58322)

Technicon OPERA Clinical Chemistry

System (61161)

ANALYTE: Potassium (4910)

TEST SYSTEM, ASSAY OR

EXAMINATION:

AVL 988–4 (04556)

American Monitor Parallel (04144)

Beckman Synchron CX 3 Delta (07548)

Beckman Synchron CX 5 CE (07491)

Boehringer Mannheim Hitachi 914 (07546)

Ciba Corning 850 (10251)

Ciba Corning 855 (10297)

Ciba Corning 860 (10269)

Ciba Corning 865 (10298)

Diametrics Medical IRMA Blood Analysis

System (13362)

Du Pont Dimension XL (13355)

I–STAT i-STAT 200 System (28344)

Instrumentation Laboratory Blood Gas

1630 (28337)

Instrumentation Laboratory Blood Gas

1640 (28338)

Instrumentation Laboratory Blood Gas

1650 (28339)

Instrumentation Laboratory IL 1430

BGElectrolyte (28343)

Instrumentation Laboratory ILAB 1800

(28323)

Instrumentation Laboratory ILAB 900

(28322)

Instrumentation Laboratory ILye Na, K, Cl

System (28320)

Instrumentation Laboratory ILye Na, K, Li

System (28319)

Ionetics Model 400/450 Electrolyte

Analyzer (28324)

Kodak Ektachem 550 XRC Analyzer

(34056)

Kodak Ektachem 700 Analyzer C Series

(34054)

Kodak Ektachem 750 XRC Analyzer

(34055)

Kodak Ektachem 950 IRC (34087)

Kodak Ektachem DT II (34057)

Medica EasyLyte Calcium Analyzer

(40197)

Nova 10 (with CRT) (43061)

Nova 16 (43103)

Nova 8 (43022)

Nova Stat Profile 9 (43086)

Nova Stat Profile Plus 10 (43063)

Nova Stat Profile Ultra 11P Analyzer

(43101)

Olympus AU 5041 (46145)

Olympus AU 5200 (46143)

PDX Stat K Rapid Potassium Test System

(49102)

PrismaSystems PROCHEM (49105)

Radiometer ABL 620 (55137)

Radiometer EML 100 (55134)

Schiapparelli Biosystems ACE Clinical

Chemistry System (58288)

StatChem StatTest Sysem (58269)

Synermed IR 500 (58322)

Technicon OPERA Clinical Chemistry

System (61161)

ANALYTE: Prealbumin (4911)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Behring Nephelometer II (07563)

ANALYTE: Prostatic Acid Phosphatase (PAP)

(4918)
25958 Federal Register / Vol. 60, No. 93 / Monday, May 15, 1995 / Notices

TEST SYSTEM, ASSAY OR

EXAMINATION:

Cirrus Diagnostics Immulite (10159)

ANALYTE: Prostatic Specific Antigen (PSA)

(4919)

TEST SYSTEM, ASSAY OR

EXAMINATION:

TOSOH A1A–1200 (61040)

ANALYTE: Protein, Total (4921)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Abaxis EPOC 2000 (04547)

Abott Spectrum CCX (04515)

Beckman Synchron CX 3 Delta (07548)

Beckman Synchron CX 4 CE (07174)

Beckman Synchron CX 5 CE (07491)

Behring Nephelometer II (07563)

Boehringer Mannheim Hitachi 914 (07546)

Du Pont ACA Star (13357)

Du Pont Dimension XL (13355)

Instrumentation Laboratory ILAB 1800

(28323)

Instrumentation Laboratory ILAB 900

(28322)

Kodak Ektachem 550 XRC Analyzer

(34056)

Kodak Ektachem 700 Analyzer C Series

(34054)

Kodak Ektachem 750 XRC Analyzer

(34055)

Kodak Ektachem 950 IRC (34087)

Kodak Ektachem DT II (34057)

LSI ASCA Chemistry System (37069)

Olympus AU 5041 (46145)

Olympus AU 5121 (46087)

Olympus AU 5200 (46143)

PrismaSystems PROCHEM (49105)

Schiapparelli Biosystems ACE Clinical

Chemistry System (58288)

Synermed IR 500 (58322)

Technicon OPERA Clinical Chemistry

System (61161)

ANALYTE: Protein, Total (urine) (4972)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Du Pont ACA Star (13357)

Du Pont Dimension (13086)

Du Pont Dimension AR (13087)

Du Pont Dimension ES (13215)

Du Pont Dimension XL (13355)

ANALYTE: Pseudocholinesterase (4923)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Du Pont ACA Star (13357)

Du Pont Dimension XL (13355)

ANALYTE: Reduced Hemoglobin (5523)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Ciba Corning 845 (10296)

Ciba Corning 855 (10297)

Ciba Corning 865 (10298)

ANALYTE: Retinol binding protein (5507)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Behring Nephelometer II (07563)

ANALYTE: Sodium (5805)

TEST SYSTEM, ASSAY OR

EXAMINATION:

AVL 988–4 (04556)

Abbott Vision (04083)

American Monitor Parallel (04144)

Beckman Synchron CX 3 Delta (07548)

Beckman Synchron CX 5 CE (07491)

Boehringer Mannheim Hitachi 914 (07546)

Ciba Corning 850 (10251)

Ciba Corning 855 (10297)

Ciba Corning 860 (10269)

Ciba Corning 865 (10298)

Diametrics Medical IRMA Blood Analysis

System (13362)

Du Pont Dimension XL (13355)

I-STAT i-STAT 200 System (28344)

Instrumentation Laboratory Blood Gas

1630 (28337)

Instrumentation Laboratory Blood Gas

1640 (28338)

Instrumentation Laboratory Blood Gas

1650 (28339)

Instrumentation Laboratory IL 1430

BGElectrolyte (28343)

Instrumentation Laboratory ILAB 1800

(28323)

Instrumentation Laboratory ILAB 900

(28322)

Instrumentation Laboratory ILyte Na, K, Cl

System (28320)

Instrumentation Laboratory ILyte Na, K, Li

System (28319)

Ionetics Model 400/450 Electrolyte

Analyzer (28324)

Kodak Ektachem 550 XRC Analyzer

(34056)

Kodak Ektachem 700 Analyzer C Series

(34054)

Kodak Ektachem 750 XRC Analyzer

(34055)

Kodak Ektachem 950 IRC (34087)

Kodak Ektachem DT II (34057)

Medica EasyLyte Calcium Analyzer

(40197)

Nova 10 (with CRT) (43061)

Nova 16 (43103)

Nova 8 (43022)

Nova Stat Profile 9 (43086)

Nova Stat Profile Plus 10 (43063)

Nova Stat Profile Ultra 11P Analyzer

(43101)

Olympus AU 5041 (46145)

Olympus AU 5200 (46143)

Radiometer ABL 620 (55137)

Radiometer EML 100 (55134)

Schiapparelli Biosystems ACE Clinical

Chemistry System (58288)

Synermed IR 500 (58322)

Technicon OPERA Clinical Chemistry

System (61161)

ANALYTE: Total Solids (Protein) (6131)

TEST SYSTEM, ASSAY OR

EXAMINATION:

ATAGO A300CL Clinincal Refractometer

(04575)

ATAGO N Serum Protein Refractometer

(04574)

ATAGO SP–D Digital Serum Protein

Refractometer (04579)

ATAGO T–2 Clinical Refractometer

(04577)

National Instrument Hand Protometer

(43085)

ANALYTE: Transferrin (6114)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Behring Nephelometer II (07563)

Boehringer Mannheim Hitachi 911 (07377)

Boehringer Mannheim Hitachi 914 (07546)

Technicon OPERA Clinical Chemistry

System (61161)

ANALYTE: Triglyceride (6118)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Abbott Spectrum CCX (04515)

Beckman Synchron CX 4 CE (07174)

Beckman Synchron CX 5 CE (07491)

Boehringer Mannheim Hitachi 914 (07546)

Du Pont ACA Star (13357)

Du Pont Dimension XL (13355)

Instrumentation Laboratory ILAB 1800

(28323)

Instrumentation Laboratory ILAB 900

(28322)

Kodak Ektachem 550 XRC Analyzer

(34056)

Kodak Ektachem 700 Analyzer C Series

(34054)

Kodak Ektachem 750 XRC Analyzer

(34055)

Kodak Ektachem 950 IRC (34087)

Kodak Ektachem DT II (34057)

LSI ASCA Chemistry System (37069)

Olympus AU 5041 (46145)

Olympus AU 5121 (46087)

Olympus AU 5200 (46143)

PrismaSystems Prochem (49105)

Schiapparelli Biosystems ACE Clinical

Chemistry System (58288)

Technicon OPERA Clinical Chemistry

System (61161)

ANALYTE: Troponin T (Tn T) (6140)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Boehringer Mannheim ES 300 (07160)

ANALYTE: Urea (BUN) (6403)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Abbott Spectrum CCX (04515)

Beckman Synchron CX 3 Delta (07548)

Beckman Synchron CX 4 CE (07174)

Beckman Synchron CX 5 CE (07491)

Boehringer Mannheim Hitachi 914 (07546)

Du Pont ACA Star (13357)

Du Pont Dimension XL (13355)

I-STAT i-STAT 200 System (28344)

Instrumentation Laboratory ILAB 1800

(28323)

Instrumentation Laboratory ILAB 900

(28322)

Kodak Ektachem 550 XRC Analyzer

(34056)

Kodak Ektachem 700 Analyzer C Series

(34054)

Kodak Ektachem 750 XRC Analyzer

(34055)

Kodak Ektachem 950 IRC (34087)

Kodak Ektachem DT II (34057)

LSI ASCA Chemistry System (37069)

Nova 16 (43103)

Nova Stat Profile Plus 10 (43063)

Olympus AU 5041 (46145)

Olympus AU 5121 (46087)

Olympus AU 5200 (46143)

PrismaSystems PROCHEM (49105)

Schiapparelli Biosystems ACE Clinical

Chemistry System (58288)

Synermed IR 500 (58322)

Technicon OPERA Clinical Chemistry

System (61161)

ANALYTE: Uric Acid (6404)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Abaxis EPOC 2000 (04547)

Abbott Spectrum CCX (04515)

Beckman Synchron CX 4 CE (07174)

Beckman Synchron CX 5 CE (07491)

Boehringer Mannheim Hitachi 914 (07546)

Du Pont ACA Star (13357)

Du Pont Dimension XL (13355)
Federal Register / Vol. 60, No. 93 / Monday, May 15, 1995 / Notices 25959

Instrumentation Laboratory ILAB 1800

(28323)

Instrumentation Laboratory ILAB 900

(28322)

Kodak Ektachem 550 XRC Analyzer

(34056)

Kodak Ektachem 700 Analyzer C Series

(34054)

Kodak Ektachem 750 XRC Analyzer

(34055)

Kodak Ektachem 950 IRC (34087)

Kodak Ektachem DT II (34057)

LSI ASCA Chemistry System (37069)

Olympus AU 5041 (46145)

Olympus AU 5200 (46143)

PrismaSystems PROCHEM (49105)

Schiapparelli Biosystems ACE Clinical

Chemistry System (58288)

Technicon OPERA Clinical Chemistry

System (61161)

ANALYTE: Vitamin B12 (6707)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Bio-Rad RADIAS System (97493)

Roche Cobas Mira Plus (55096)

Sanofi Pasteur Access Immunoassay

System (58257)

Syva Vista Immunoassay System (58221)

Technicon Immuno 1 System (61042)

SPECIALITY/SUBSPECIALITY: General

Immunology

ANALYTE: Allergen specific IgE (0417)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Cirrus Diagnostic Immulite (10159)

In Vitro Technologies Allergy Profile

(28279)

Sanofi Pasteur Access Immunoassay

System (58257)

ANALYTE: Alpha-1 Microglobin (0470)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Beckman Array 360 (07052)

Behring Nephelometer II (07563)

ANALYTE: Alpha-1-Acid Glycoprotein

(orosomucoid) (0420)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Behring Nephelometer II (07563)

Alpha-1-Antitrypsin (0421)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Behring Nephelomoter II (07563)

ANALYTE: Alpha-2 Macroglobulin (0422)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Behring Nephelometer II (07563)

ANALYTE: Alpha-Fetoprotein—Tumor

Marker (0424)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Boehringer Mannheim ES 300 AL (07524)

ANALYTE: Anti-Nuclear Antibodies (ANA)

(0441)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Bio-Rad Radias System (07493)

J & S Medical Accutex SLE Latex Test

(31002)

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

TEST SYSTEM, ASSAY OR

EXAMINATION:

Beckman Synchron CX 5 CE (07491)

Behring Nephelometer II (07563)

J & S Medical Accutex Antistreptolysin O

(ASO) Latex Text (31006)

ANALYTE: Beta-2 microglobulin (0703)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Beckman Array 360 (07052)

Cirrus Diagnostics Immulite (10159)

Du Pont ACA Star (13357)

Du Pont ACA V (13084)

Wallac Oy AutoDELFIA (70167)

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

TEST SYSTEM, ASSAY OR

EXAMINATION:

Beckman Synchron CX 5 CE (07491)

Behring Nephelometer II (07563)

Boehringer Mannheim Hitachi 747 (07166)

Boehriner Mannheim Hitachi 914 (07546)

Du Pont ACA Star (13357)

Du Pont Dimension XL (13355)

Immunostics immuno/crp Test (28277)

J & S Medical Accutex C-Reactive Protein

(CRP) Latex Text (31004)

J & S Medical Eye Spot CRP test (31007)

Pulse Scientific C-Reactive Protein (CRP)

Test (49075)

Technicon OPERA Clinical Chemistry

System (61161

ANALYTE: Complement C3 (1029)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Behring Nephelometer II (07563)

Boehringer Mannheim Hitachi 914 (07546)

Technicon OPERA Clinical Chemistry

System (61161)

ANALYTE: Complement C4 (1030)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Behring Nephelometer II (07563)

Boehringer Mannheim Hitachi 914 (07546)

Technicon OPERA Clinical Chemistry

System (61161)

ANALYTE: Cytomegalovirus Antibodies

(1039)

TEST SYSTEM, ASSAY OR

EXAMINATION:

PB Diagnostics System OPUS (49001)

PB Diagnostics Systems OPUS Magnum

(49097)

PB Diagnostics Systems OPUS PLUS

(49098)

Vitek Systems Vidas (67038)

ANALYTE: Helicobacter Pylori Antibodies

(2513)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Meridian Diagnostics ImmunoCard H.

pylori (40195)

SmithKline FlexSure HP Test (58321)

ANALYTE: Hemopexin (2517)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Behring Nephelometer II (07563)

ANALYTE: Hepatitis A Virus Antibody

(2519)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Abbott IMX (04056)

ANALYTE: Immunoglobulins IgA (2803)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Beckman Synchron CX 5 CE (07491)

Behring Nephelometer II (07563)

Boehringer Mannheim Hitachi 914 (07546)

Du Pont ACA Star (13357)

Technicon OPERA Clinical Chemistry

System (61161)

ANALYTE: Immunoglobulins IgE (2805)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Boehringer Mannheim ES 300 AL (07524)

Cirrus Diagnostics Immulite (10159)

Roche Cobas Core (55119)

Sanofi Pasteur Access Immunoassay

System (58257)

Vitek Systems Vidas (67038)

ANALYTE: Immunoglobulins IgG (2806)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Beckman Synchron CX 5 CE (07491)

Behring Nephelometer II (07563)

Boehringer Mannheim Hitachi 914 (07546)

Du Pont ACA Star (13357)

Technicon OPERA Clinical Chemistry

System (61161)

ANALYTE: Immunoglobulins IgG subclasses

(2807)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Behring Nephelometer (07273)

Behring Nephelometer 100 (07272)

ANALYTE: Immunoglobulins IgM (2808)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Beckman Synchron CX 5 CE (07491)

Behring Nephelometer II (07563)

Boehringer Mannheim Hitachi 914 (07546)

Du Pont ACA Star (13357)

Technicon OPERA Clinical Chemistry

System (61161)

ANALYTE: Infectious Mononucleosis

Antibodies (Mono) (2809)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Immunostics immuno/im test (28278)

J & S Medical Accutex Inf. Mono. Red Bld.

Cell (IM RBC) Test (31003)

J & S Medical Accutex Infectious

Mononucleosis Latex Test (31008)

J & S Medical Eye Spot Infectious

Mononucleosis (IM) Test (31013)

Meridian Diagnostics ImmunoCard Mono

(40179)

Pacific Biotech Concise Plus Mono (49148)

Princeton BioMeditech BioSign Mono Test

(49100)

ANALYTE: Kappa Light Chains (3402)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Behring Nephelometer II (07563)

ANALYTE: Lambda Light Chains (3705)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Behring Nephelometer II (07563)

ANALYTE: Mumps Antibodies (4007)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Vitek Systems Vidas (67038)

ANALYTE: Mycoplasma pneumoniae

Antibodies (4016)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Meridian Diagnostics ImmunoCard

Mycoplasma (40196)

Murex Mycoplasma pneumoniae Antibody

Detection Kit (40175)

ANALYTE: Rheumatoid Factor (RF) (5508)

TEST SYSTEM, ASSAY OR

EXAMINATION:
25960 Federal Register / Vol. 60, No. 93 / Monday, May 15, 1995 / Notices

Behring Nephelometer II (07563)

Immunostics immuno/undiluted ra Test

(28275)

J & S Medical Accutex Rheumatoid Factor

(RF) Latex Test (31005)

J & S Medical Eye Spot Rheumatoid Factor

(RF) Test (31012)

Pulse Scientific Rheumatoid Factor (RF)

Test (49101)

Trinity Laboratories RHEUMA–LEX

System (61116)

ANALYTE: Rickettsia typhi Ab (Typhus

Antibodies) (5514)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Integrated Diagnostics INDX DIP–S–TICKS

R. typhi (28265)

ANALYTE: Rubella Antibodies (5510)

TEST SYSTEM, ASSAY OR

EXAMINATION:

PB Diagnostics Systems OPUS Magnum

(49097)

PB Diagnostics Systems OPUS PLUS

(49098)

Princeton BioMeditech BioSign Rubella

(49121)

Wampole IMPACT Rubella Slide Test

(70165)

ANALYTE: Rubeola Antibodies (measles)

(5511)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Vitek Systems Vidas (67038)

ANALYTE: Toxoplasma gondii Antibodies

(6113)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Beckman Synchron CX 5 CE (07491)

Biokit Toxogen (07494)

PB Diagnostics Systems OPUS (49001)

PB Diagnostics Systems OPUS Magnum

(49097)

PB Diagnostics Systems OPUS PLUS

(49098)

Vitek Systems Vidas Toxo Competition

(TXC) Assay (67080)

ANALTYE: Varicella-Zoster Virus Antibodies

(6704)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Vitek Systems Vidas (67038)

SPECIALITY/SUBSPECIALITY: Hematology

ANALYTE: Activated Clotting Time (ACT)

(0461)

TEST SYSTEM, ASSAY OR

EXAMINATION:

HemoTec Automated Coagulation Timer

High Range Heparinase (25184)

HemoTec Automated Coagulation Timer II

(25180)

HemoTec Automated Coagulation Timer II

High Range Heparinase (25185)

International Technidyne Hemochron 8000

(28298)

International Technidyne Hemochron Jr.

Microcoagulation (28345)

ANALYTE: Activated Partial Thromboplastin

Time (APTT) (0409)

TEST SYSTEM, ASSAY OR

EXAMINATION:

American Bioproducts STA Analyzer

(04594)

Behring Fibrintimer A (07516)

Cardiovascular Diagnostics TAS Analyzer

(10257)

Helena Laboratories Cascade M (25156)

HemoTec Automated Coagulation Timer II

(25180)

Instrumentation Laboratory MCL 2

Coagulation Analyzer (28297)

International Technidyne Factor VI

Premier (28296)

International Technidyne Factor VI

Premier SingleShot APTT (28293)

International Technidyne Factor VI

Premier Vacu-APTT (28295)

International Technidyne Factor VI

SingleShot APTT (28292)

International Technidyne Factor VI VacuAPTT (28294)

International Technidyne Hemochron 400

Cit. One-Step APTT (28287)

International Technidyne Hemochron 400

Direct Draw APTT (28282)

International Technidyne Hemochron 401

Cit. One-Step APTT (28288)

International Technidyne Hemochron 401

Direct Draw APTT (28283)

International Technidyne Hemochron 800

Cit. One-Step APTT (28289)

International Technidyne Hemochron 800

Direct Draw APTT (28284)

International Technidyne Hemochron 8000

(28298)

International Technidyne Hemochron 8000

Cit. One-Step APTT (28291)

International Technidyne Hemochron 8000

Direct Draw APTT (28286)

International Technidyne Hemochron 801

Cit. One-Step APTT (28290)

International Technidyne Hemochron 801

Direct Draw APTT (28285)

International Technidyne Microsample

Coagulation Analyzer (28267)

Medical Laboratory MLA Electra 1600C

(40167)

Organon Teknika Multi Channel Discrete

Analyzer (MDA–180) (46144)

TOA Medical Electronics CA–1000 (61132)

TOA Medical Electronics CA–5000 (61135)

Vitek HEMOLAB (67075)

ANALYTE: Antithrombin III (ATIII) (0456)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Behring Nephelometer II (07563)

Du Pont ACA Star (13357)

ANALYTE: Body Fluid Microscopic

Elements (0716)

TEST SYSTEM, ASSAY OR

EXAMINATION:

IRIS IRIScope Body Fld. Cell Count Sys.

(RBC/WBC enum. only) (28333)

ANALYTE: Capillary fragility (1093)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Capillary Fragility/Tourniquet Test (10247)

ANALYTE: Fibrin Monomers (1927)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Ethanol Gel; Protamine Sulfate (no serial

dilutions) (16044)

ANALYTE: Fibrin Split Products (Fibrin

Degradation) (1904)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Baxter Diagnostic Dimertest Latex Assay

(07552)

Baxter Diagnostic FDP Detection Set

(07551)

Du Pont ACA Star (13357)

Organon Teknika AuraTek FDP (46153)

Vitek FDP Slidex direct (67084)

ANALYTE: Fibrinogen (1905)

TEST SYSTEM, ASSAY OR

EXAMINATION:

American Bioproducts STA Analyzer

(04594)

Behring Nephelometer II (07563)

Du Pont ACA Star (13357)

Helena Laboratories Cascade M (25156)

Instrumentation Laboratory MCL 2

Coagulation Analyzer (28297)

International Technidyne Factor VI (28093)

International Technidyne Factor VI

Premier (28296)

International Technidyne Hemochron 400

(28094)

International Technidyne Hemochron 401

(28095)

International Technidyne Hemochron 800

(28096)

International Technidyne Hemochron 8000

(28298)

International Technidyne Hemochron 801

(28097)

Medical Laboratory MLA Electra 1600C

(40167)

TOA Medical Electronics CA–1000 (61132)

TOA Medical Electronics CA–5000 (61135)

Vitek HEMOLAB (67075)

ANALYTE: Hematocrit (2514)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Abbott Cell-Dyn 1700 (04607)

Abbott EnCounter (04525)

Alicia Diagnostic Genesis I (04536)

Coulter ONYX (10254)

Coulter ONYX with Autoloader (10281)

DMA H12 (13284)

Danam Datacell 16CP (13363)

Diametrics Medical IRMA Blood Analysis

System (13362)

I-STAT i-STAT 200 System (28344)

Infolab I–1600 (28379)

Instrumentation Laboratory BGElectrolytes

(28063)

Nova 16 (43103)

Nova Stat Profile 9 (43086)

Nova Stat Profile Plus 10 (43063)

Nova Stat Profile Ultra 11P Analyzer

(43101)

Separation Technology STI HemataSTAT

Model C70B (58310)

Sysmex K–4500 (58358)

Sysmex K–800 (58307)

Sysmex SE–9000 (58318)

Technalysis CELLEXIS Hematology

Analyzer (61102)

Technicon H.3 RTC System (61103)

Technicon H. 3 RTX System (61104)

Texas International Laboratories H12

(61128)

ANALYTE: Hemoglobin (2515)

TEST SYSTEM, ASSAY OR

EXAMINATION:

AVL 995 Hb (04021)

Abbott Cell-Dyn 1700 (04607)

Abbott EnCounter (04525)

Alicia Diagnostics Genesis I (04536)

Artel HbM Hemoglobinometer (04551)

Ciba Corning 280 (10036)

Ciba Corning 288 (10037)

Ciba Corning 845 (10296)

Ciba Corning 855 (10297)

Ciba Corning 865 (10298)

Coulter ONYX (10254)
Federal Register / Vol. 60, No. 93 / Monday, May 15, 1995 / Notices 25961

Coulter ONYX with Autoloader (10281)

DMA H12 (13284)

Danam Datacell 16CP (13363)

I-STAT i-STAT 200 System (28344)

Infolab I–1600 (28379)

Radiometer ABL 1 (55049)

Radiometer ABL 2 (55001)

Radiometer ABL 2 RA (55050)

Radiometer ABL 3 (55002)

Radiometer ABL 3 M (55051)

Radiometer ABL 300 (55004)

Radiometer ABL 4 (55006)

Radiometer ABL 510 (55054)

Radiometer ABL 520 (55055)

Separation Technology STI HemataSTAT

Model C70B (58310)

StatChem StatTest System (58269)

Sysmex K–4500 (58358)

Sysmex K–800 (58307)

Sysmex SE–9000 (58318)

Technalysis CELLEXIS Hematology

Analyzer (61102)

Technicon H.3 RTC System (61103)

Technicon H.3 RTX System (61104)

Texas International Laboratories H12

(61128)

ANALYTE: Heparin (2518)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Du Pont ACA Star (13357)

ANALYTE: Heparin Dose Response (HDR)

(2539)

TEST SYSTEM, ASSAY OR

EXAMINATION:

International Technidyne Factor VI (28093)

International Technidyne Hemochron 400

(28094)

International Technidyne Hemochron 401

(28095)

International Technidyne Hemochron 800

(28096)

International Technidyne Hemochron 8000

(28298)

International Technidyne Hemochron 801

(28097)

ANALYTE: Plasminogen (4907)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Behring Nephelometer II (07563)

Du Pont ACA Star (13357)

ANALYTE: Platelet Count (4908)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Abbott Cell-Dyn 1700 (04607)

Abbott EnCounter (04525)

Alicia Diagnostics Genesis I (04536)

Coulter ONYX (10254)

Coulter ONYX with Autoloader (10281)

DMA H12 (13284)

Danam Datacell 16CP (13363)

Infolab I–1600 (28379)

Sysmex K–4500 (58358)

Sysmex K–800 (58307)

Sysmex SE–9000 (58318)

Technalysis CELLEXIS Hematology

Analyzer (61102)

Technicon H.3 RTC System (61103)

Technicon H.3 RTX System (61104)

Texas International Laboratories H12

(61128)

ANALYTE: Prothrombin Time (PT) (4922)

TEST SYSTEM, ASSAY OR

EXAMINATION:

American Bioproducts STA Analyzer

(04594)

Behring Fibrintimer A (07516)

Boehringer Mannheim CoaguChek System

(07496)

Cardiovascular Diagnostics TAS Analyzer

(10257)

Helena Laboratories Cascade M (25156)

HemoTec Automated Coagulation Timer II

(25180)

Instrumentation Laboratory MCL 2

Coagulation Analyzer (28297)

International Technidyne Factor VI Jr.

Microcoagulation (28346)

International Technidyne Factor VI

Premier (28296)

International Technidyne Hemochron 8000

(28298)

International Technidyne Hemocrhon Jr.

Microcoagulation (28345)

Medical Laboratory MLA Electra 1600C

(40167)

Organon Teknika Multi Channel Discrete

Analyzer (MDA–180) (46144)

TOA Medical Electronics CA–1000 (61132)

TOA Medical Electronics CA–5000 (61135)

Vitek HEMOLAB (67075)

ANALYTE: Red Blood Cell Count

(Erythrocyte Count) (RBC) (5502)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Abbott Cell-Dyn 1700 (04607)

Abbott EnCounter (04525)

Alicia Diagnostics Genesis I (04536)

Coulter ONYX (10254)

Coulter ONYX with Autoloader (10281)

DMA H12 (13284)

Danam Datacell 16CP (13363)

Infolab I–1600 (28379)

Sysmex K–4500 (58358)

Sysmex K–800 (58307)

Sysmex SE–9000 (58318)

Technalysis CELLEXIS Hematology

Analyzer (61102)

Technicon H.3 RTC System (61103)

Technicon H.3 RTX System (61104)

Texas International Laboratories H12

(61128)

ANALYTE: Reticulocyte Count (5506)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Becton Dickinson FACSCAN (with retic

count software) (07518)

Coulter MAXM (10078)

Coulter STKS (10093)

Technicon H.3 RTC System (61103)

Technicon H.3 RTX System (61104)

ANALYTE: Semen (5822)

TEST SYSTEM, ASSAY OR

EXAMINATION:

IRIS IRIScope Body Fld. Cell Count Sys.

(sperm enum. only) (28334)

ANALYTE: Thrombin Time (6105)

TEST SYSTEM, ASSAY OR

EXAMINATION:

American Bioproducts STA Analyzer

(04594)

Helena Laboratories Cascade M (25156)

Instrumentation Laboratory MCL 2

Coagulation Analyzer (28297)

International Technidyne Factor VI

Premier (28296)

International Technidyne Factor VI

Preimer Throm. Time Plus (28310)

International Technidyne Factor VI

Thrombin Time Plus (28309)

International Technidyne Hemochron 400

HNTT (28299)

International Technidyne Hemochron 400

HiTT (28304)

International Technidyne Hemochron 401

HNTT (28300)

International Technidyne Hemochron 401

HiTT (28305)

International Technidyne Hemochron 800

HNTT (28301)

International Technidyne Hemochron 800

HiTT (28306)

International Technidyne Hemochron 8000

(28298)

International Technidyne Hemochron 8000

HNTT (28303)

International Technidyne Hemochron 8000

HiTT (28308)

International Technidyne Hemochron 801

HNTT (28302)

International Technidyne Hemochron 801

HiTT (28307)

Medical Laboratory MLA Electra 1600C

(40167)

TOA Medical Electronics CA–1000 (61132)

TOA Medical Electronics CA–5000 (61135)

Vitek HEMOLAB (67075)

ANALYTE: White Blood Cell Count

(Leukocyte Count) (WBC) (7002)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Abbott Cell-Dyn 1700 (04607)

Abbott EnCounter (04525)

Alicia Diagnostics Genesis I (04536)

Coulter ONYX (10254)

Coulter ONYX with Autoloader (10281)

DMA H12 (13284)

Danam Datacell 16CP (13363)

Infolab I–1600 (28379)

Sysmex K–4500 (58358)

Sysmex K–800 (58307)

Sysmex SE–9000 (58318)

Technalysis CELLEXIS Hematology

Analyzer (61102)

Technicon H.3 RTC System (61103)

Technicon H.3 RTX (61104)

Texas International Laboratories H12

(61128)

ANALYTE: White Blood Cell Differential

(WBC Diff) (7001)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Abbott Cell-Dyn 1700 (04607)

Abbott EnCounter (04525)

Alicia Diagnostics Genesis I (04536)

Coulter ONYX (10254)

Coulter ONYX with Autoloader (10281)

DMA H12 (13284)

Danam Datacell 16CP (13363)

Infolab I–1600 (28379)

Sysmex K–4500 (58358)

Sysmex SE–9000 (58318)

Technalysis CELLEXIS Hematology

Analyzer (61102)

Technicon H.3 RTC System (61103)

Technicon H.3 RTX System (61104)

Texas International Laboratories H12

(61128)

SPECIALITY/SUBSPECIALITY: Mycology

ANALYTE: Dermatophytes (1302)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Biomed Diagnostics InTray DM Medium

(07559)

Troy Biologicals Dermatophyte Test

Medium (61106)

ANALYTE: Yeast, Candida only (7603)
25962 Federal Register / Vol. 60, No. 93 / Monday, May 15, 1995 / Notices

TEST SYSTEM, ASSAY OR

EXAMINATION:

MicroProbe Affirm VPIII Microbial

Identification Test (40163)

SPECIALITY/SUBSPECIALITY: Parasitology

ANALYTE: Cryptosprodium (1109)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Alexon ProSpecT Cryptosporidum Rapid

Assay (dir. Ag/vis.) (04553)

ANALYTE: Giardia lamblia (2222)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Alexon ProSpecT Giardia Rapid Assay

(direct antigen/visual) (04364)

ANALYTE: Scabies (5831)

TEST SYSTEM, ASSAY OR

EXAMINATION:

All Direct Wet Mount Preparations (04108)

ANALYTE: Trichomonas (6116)

TEST SYSTEM, ASSAY OR

EXAMINATION:

MicroProbe Affirm VPIII Microbial

Identification Test (40163)

SPECIALITY/SUBSPECIALITY: Toxicology/

TDM

ANALYTE: Acetaminophen (0406)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Du Pont ACA Star (13357)

GDS Diagnostics Stat-Site Meter (22126)

ANALYTE: Amikacin (0425)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Du Pont ACA Star (13357)

ANALYTE: Amphetamines (0428)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Beckman Synchron CX 5 CE (07491)

Biosite Triage Panel Drugs of Abuse plus

Tricyl.Antidprsnt. (07528)

Boehringer Mannheim Hitachi 911 (07377)

Boehringer Mannheim Hitachi 914 (07546)

Drug Screening Systems microLINE

Screens (13259)

Du Pont ACA Star (13357)

Olympus AU 5041 (46145)

Olympus AU 5121 (46087)

Olympus AU 5200 (46143)

Princeton BioMeditech AbuSign DOA 4

(49130)

ANALYTE: Barbiturates (0701)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Beckman Synchron CX 5 CE (07491)

Biosite Triage Panel Drugs of Abuse plus

Tricyl.Antidprsnt. (07528)

Boehringer Mannheim Hitachi 914 (07546)

Drug Screening Systems microLINE

Screens (13259)

Du Pont ACA Star (13357)

Olympus AU 5041 (46145)

Olympus AU 5121 (46087)

Olympus AU 5200 (46143)

Schiapparelli Biosystems ACE Clinical

Chemistry System (58288)

ANALYTE: Benzodiazepines (0702)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Beckman Synchron CX 5 CE (07491)

Biosite Triage Panel Drugs of Abuse plus

Tricyl.Antidprsnt. (07528)

Boehringer Mannheim Hitachi 914 (07546)

Drug Screening Systems microLINE

Screens (13259)

Du Pont ACA Star (13357)

Olympus AU 5041 (46145)

Olympus AU 5121 (46087)

Olympus AU 5200 (46143)

ANALYTE: Cannabinoids (THC) (1009)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Beckman Synchron CX 5 CE (07491)

Biosite Triage Panel Drugs of Abuse plus

Tricyl.Antidprsnt. (07528)

Boehringer Mannheim Hitachi 914 (07546)

Du Pont ACA Star (13357)

Olympus AU 5041 (46145)

Olympus AU 5121 (46087)

Olympus AU 5200 (46143)

Princeton BioMeditech AbuSign DOA 4

(49130)

Princeton BioMeditech AbuSign THC

(49133)

Princeton BioMeditech AccuSign THC

(49139)

Princeton BioMeditech BioSign THC

(49137)

Princeton BioMeditech DOA–COC (49135)

Roche OnTrak TESTCUP Collection/

Urinalysis Panel (55146)

ANALYTE: Carbamazepine (1010)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Abbott AxSYM (04532)

Boehringer Mannheim Hitachi 914 (07546)

Du Pont ACA Star (13357)

Instrumentation Laboratory ILAB 1800

(28323)

Instrumentation Laboratory ILAB 1800

(28322)

PB Diagnostics Systems OPUS Magnum

(49097)

PB Diagnostics Systems OPUS Magnum

(49098)

Seradyn LPIA–100 (58294)

ANALYTE: Carboxyhemoglobin (1012)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Ciba Corning 845 (10296)

Ciba Corning 855 (10297)

Ciba Corning 865 (10298)

Radiometer ABL 620 (55137)

ANALYTE: Cocaine Metabolites (1023)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Beckman Synchron CX 5 CE (07491)

Biosite Triage Panel Drugs of Abuse plus

Tricyl.Antidprsnt. (07528)

Boehringer Mannheim Hitachi 911 (07377)

Boehringer Mannheim Hitachi 914 (07546)

Du Pont ACA Star (13357)

EDITEK VERDICT COCAINE (16078)

Olympus AU 5041 (46145)

Olympus AU 5121 (46087)

Olympus AU 5200 (46143)

Princeton BioMeditech AbuSign COC

(49132)

Princeton BioMeditech AbuSign DOA 4

(49130)

Princeton BioMeditech AccuSign COC

(49138)

Princeton BioMeditech BioSign COC

(49136)

Princeton BioMeditech DOA–TCO (49134)

Roche OnTrak TESTCUP Collection/

Urinalysis Panel (55146)

Schiapparelli Biosystems ACE Clinical

Chemistry System (58288)

ANALYTE: Digitoxin (1303)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Cirrus Diagnostics Immulite (10159)

Du Pont ACA Star (13357)

ANALYTE: Digoxin (1304)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Abbott AxSYM (04532)

Beckman Synchron CX 4 CE (07174)

Beckman Synchron CX 5 CE (07491)

Boehringer Mannheim ES 300 AL (07524)

Boehringer Mannheim Hitachi 914 (07546)

Du Pont ACA Star (13357)

Du Pont Dimension XL (13355)

Kodak Ektachem 250 (34037)

Kodak Ektachem 950 IRC (34087)

PB Diagnostics Systems OPUS Magnum

(49097)

PB Diagnostics Systems OPUS PLUS

(49098)

Sanofi Pasteur Access Immunoassay

System (58257)

Schiapparelli Biosystems ACE Clinical

Chemistry System (58288)

Technicon OPERA Clinical Chemistry

System (61161)

Vitek Systems Vidas (67038)

Wako Diagnostics 30R (70002)

ANALYTE: Ethanol (Alcohol) (1608)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Beckman Synchron CX 5 CE (07491)

Boehringer Mannheim Hitachi 914 (07546)

Du Pont ACA Star (13357)

Du Pont Dimension XL (13355)

Kodak Ektachem 950 IRC (34087)

Olympus AU 5041 (46145)

ANALYTE: Ethosuximide (1609)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Du Pont ACA Star (13357)

ANALYTE: Gentamicin (2202)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Abbott AxSYM (04532)

Beckman Synchron CX 5 CE (07491)

Boehringer Mannheim Hitachi 914 (07546)

Du Pont ACA Star (13357)

Instrumentation Laboratory ILAB 1800

(28323)

Instrumentation Laboratory ILAB 900

(28322)

PB Diagnostics Systems OPUS Magnum

(49097)

PB Diagnostics Systems OPUS PLUS

(49098)

Seradyn LPIA–100 (58294)

Technicon OPERA Clinical Chemistry

System (61161)

ANALYTE: Isonicotinic Acid (2819)

TEST SYSTEM, ASSAY OR

EXAMINATION:

DynaGen MYCODYN URITEC Test Strips

(13264)

ANALYTE: Lidocaine (3710)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Du Pont ACA Star (13357)

ANALYTE: Lithium (3712)

TEST SYSTEM, ASSAY OR

EXAMINATION:
Federal Register / Vol. 60, No. 93 / Monday, May 15, 1995 / Notices 25963

Instrumentation Laboratory ILyte Na, K, Li

System (28319)

Ionetics Model 400/450 Electrolyte

Analyzer (28324)

Kodak Ektachem 250 (34037)

Kodak Ektachem 400 (34012)

Kodak Ektachem 500 (34013)

Kodak Ektachem 550 XRC Analyzer

(34056)

Kodak Ektachem 700 (34014)

Kodak Ektachem 700 Analyzer C Series

(34054)

Kodak Ektachem 700 P (34024)

Kodak Ektachem 700 XR (34015)

Kodak Ektachem 750 XRC Analyzer

(34055)

Kodak Ektachem 950 IRC (34087)

Kodak Ektachem DT 60 (34016)

Kodak Ektachem DT II (34057)

Kodak Ektachem DT SC II Module (34028)

Kodak Ektachem DT SC Module (34017)

Kodak Ektachem DTE Module (34018)

Nova 10 (with CRT) (43061)

ANALYTE: Methadone (4003)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Beckman Synchron CX 5 CE (07491)

Biosite Triage Panel for Drugs of Abuse

(07195)

Boehringer Mannheim Hitachi 914 (07546)

Du Pont ACA (13082)

Du Pont ACA II (13172)

Du Pont ACA III (13173)

Du Pont ACA IV (13083)

Du Pont ACA Star (13357)

Du Pont ACA V (13084)

Olympus AU 5041 (46145)

Olympus AU 5121 (46087)

Olympus AU 5200 (46143)

Roche Abuscreen ONTRAK (55099)

ANALYTE: Methamphetamines (4004)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Biosite Triage Panel Drugs of Abuse plus

Tricyl.Antidprsnt. (07528)

ANALYTE: Methaqualone (4005)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Boehringer Mannheim Hitachi 914 (07546)

Olympus AU 5041 (46145)

Olympus AU 5121 (46087)

Olympus AU 5200 (46143)

ANALYTE: Methotrexate (4006)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Du Pont ACA Star (13357)

ANALYTE: Morphine (4020)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Roche OnTrak TESTCUP Collection/

Urinalysis Panel (55146)

Sun Biomedical Labs Visualine II

Morphine/Opiates/Heroin (58359)

ANALYTE: N-Acetylprocainamide (NAPA)

(4301)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Du Pont ACA Star (13357)

PB Diagnostics Systems OPUS (49001)

PB Diagnostics Systems OPUS Magnum

(49097)

PB Diagnostics Systems OPUS PLUS

(49098)

ANALYTE: Opiates (4601)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Beckman Synchron CX 5 CE (07491)

Biosite Triage Panel Drugs of Abuse plus

Tricyl.Antidpresnt. (07528)

Boehringer Mannheim Hitachi 911 (07377)

Boehringer Mannheim Hitachi 914 (07546)

Du Pont ACA Star (13357)

EDITEK VERDICT OPIATES (16077)

Olympus AU 5041 (46145)

Olumpus AU 5121 (46087)

Olympus AU 5200 (46143)

Princeton BioMeditech AbuSign DOA 4

(49130)

Princeton BioMeditech AbuSign Opi

(49144)

Princeton BioMeditech AccuSign Opi

(49146)

Princeton BioMeditech BioSign Opi

(49147)

Princeton BioMeditech DOA-Opi (49145)

ANALYTE: Phencyclidine (PCP) (4901)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Beckman Synchron CX 5 CE (07491)

Biosite Triage Panel Drugs of Abuse plus

Tricyl.Antidprsnt. (07528)

Boehringer Mannheim Hitachi 914 (07546)

Du Pont ACA Star (13357)

EDITEK EZ-Screen:PCP (16073)

Olympus AU 5041 (46145)

Olympus AU 5121 (46087)

Olympus AU 5200 (46143)

Schiapparelli Biosystems ACE Clinical

Chemistry System (58288)

ANALYTE: Phenobarbital (4902)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Abbott AxSYM (04532)

Baxter Paramax (07048)

Baxter Paramax 720 (07186)

Baxter Paramax 720 ZX (07049)

Beckman Synchron CX 5 CE (07491)

Boehringer Mannheim Hitachi 914 (07546)

Du Pont ACA Star (13357)

Du Pont Dimension XL (13355)

Instrumentation Laboratory ILAB 1800

(28323)

Instrumentation Laboratory ILAB 900

(28322)

PB Diagnostics Systems OPUS Magnum

(49097)

PB Diagnostics Systems OPUS PLUS

(49098)

Schiapparelli Biosystems ACE Clinical

Chemistry System (58288)

Seradyn LPIA–100 (58294)

Technicon OPERA Clinical Chemistry

System (61161)

ANALYTE: Phenytoin (4903)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Abbott AxSYM (04532)

Baxter Paramax (07048)

Baxter Paramax 720 (07186)

Baxter Paramax 720 ZX (07049)

Beckman Synchron CX 5 CE (07491)

Boehringer Mannheim Hitachi 914 (07546)

Du Pont ACA Star (13357)

Du Pont Dimension XL (13355)

Kodak Ektachem 250 (34037)

Kodak Ektachem 950 IRC (34087)

PB Diagnostics Systems OPUS Magnum

(49097)

PB Diagnostics Systems OPUS PLUS

(49098)

Schiapparelli Biosystems ACE Clinical

Chemistry System (58288)

Technicon OPERA Clinical Chemistry

System (61161)

ANALYTE: Primidone (4912)

TEST SYSTEM, ASSAY OR

EXAMINATION

Boehringer Mannheim Hitachi 914 (07546)

Du Pont ACA Star (13357)

ANALYTE: Procainamide (4913)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Du Pont ACA Star (13357)

PB Diagnostics System OPUS (49001)

ANALYTE: Propoxyphene (4917)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Olympus AU 5041 (46145)

Olympus AU 5121 (46087)

Olympus AU 5200 (46143)

ANALYTE: Quinidine (5202)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Abbott AxSYM (04532)

Boehringer Mannheim Hitachi 914 (07546)

Du Pont ACA Star (13357)

ANALYTE: Salicylates (5801)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Beckman Synchron CX 5 CE (07491)

Boehringer Mannheim Hitachi 914 (07546)

Du Pont ACA Star (13357)

Du Pont Dimension XL (13355)

Kodak Ektachem 550 XRC Analyzer

(34056)

Kodak Ektachem 700 Analyzer C Series

(34054)

Kodak Ektachem 750 XRC Analyzer

(34055)

Kodak Ektachem 950 (IRC (34087)

ANALYTE: Theophylline (6104)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Abbott AxSYM (04532)

Baxter Paramax (07048)

Baxter Paramax 720 (07186)

Baxter Paramax 720 ZX (07049)

Beckman Synchron CX 5 CE (07491)

Boehringer Mannheim Hitachi 914 (07546)

Du Pont ACA Star (13357)

Du Pont Dimension XL (13355)

Immunomatrix Theophylline Blood

Monitoring System (28318)

Instrumentation Laboratory ILAB 1800

(28323)

Instrumentation Laboratory ILAB 900

(28322)

Kodak Ektachem 550 XRC Analyzer

(34056)

Kodak Ektachem 700 Analyzer C Series

(34054)

Kodak Ektachem 750 XRC Analyzer

(34055)

Kodak Ektachem 950 IRC (34087)

Kodak Ektachem DT II (34057)

PB Diagnostics Systems OPUS Magnum

(49097)

PB Diagnostics Systems OPUS PLUS

(49098)

Schiapparelli Biosystems ACE Clinical

Chemistry System (58288)

Technicon OPERA Clinical Chemistry

System (61161)

Vitek Systems Vidas (67038)

ANALYTE: Tobramycin (6112)

TEST SYSTEM, ASSAY OR

EXAMINATION:
25964 Federal Register / Vol. 60, No. 93 / Monday, May 15, 1995 / Notices

Abbott AxSYM (04532)

Beckman Synchron CX 5 CE (07491)

Boehringer Mannheim Hitachi 911 (07377)

Boehringer Mannheim Hitachi 914 (07546)

Du Pont ACA Star (13357)

PB Diagnostics Systems OPUS Magnum

(49097)

PB Diagnostics Systems OPUS PLUS

(49098)

Technicon OPERA Clinical Chemistry

System (61161)

ANALYTE: Tricyclic Antidepressants (6117)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Biosite Triage Panel Drugs of Abuse plus

Tricyl.Antidprsnt. (07528)

Du Pont ACA Star (13357)

ANALYTE: Valproic Acid (6701)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Abbott AxSYM (04532)

Boehringer Mannheim Hitachi 704 (07161)

Boehringer Mannheim Hitachi 717 (07163)

Boehringer Mannheim Hitachi 911 (07377)

Boehringer Mannheim Hitachi 914 (07546)

Ciba Corning Biotrack 516 (10048)

Du Pont ACA Star (13357)

PB Diagnostics Systems OPUS Magnum

(49097)

PB Diagnostics Systems OPUS PLUS

(49098)

Seradyn LPIA–100 (58294)

ANALYTE: Vancomycin (6703)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Abbott AxSYM (04532)

Du Pont ACA Star (13357)

PB Diagnostics Systems OPUS (49001)

PB Diagnostics Systems OPUS Magnum

(49097)

PB Diagnostics Systems OPUS PLUS

(49098)

SPECIALITY/SUBSPECIALITY: Urinalysis

ANALYTE: Total Solids (Specific Gravity)

(6125)

TEST SYSTEM, ASSAY OR

EXAMINATION:

ATAGO A300CL Clinical Refractometer

(04575)

ATAGO T–2 Clinical Refractometer

(04577)

ATAGO UG–1 Digital Urine Specific

Gravity Refractometer (04576)

ATAGO URICON–PN Urine Specific

Gravity Refractometer (04578)

Ames Clinitek Atlas Automated Urine

Analyzer (04527)

IRIS The Yellow IRIS Model 250 (28369)

IRIS The Yellow IRIS Model 450 (28370)

National Instrument Hand Protometer

(43085)

ANALYTE: Urine Qualitative Dipstick

Chemistries (6406)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Ames Clinitek Atlas Automated Urine

Analyzer (04527)

Boehringer Mannheim CHEMSTRIP Mini

UA Urine Analyzer (07565)

Boehringer Mannheim Chemstrip Super

UA Urine Analyzer (07520)

SPECIALITY/SUBSPECIALITY: Virology

ANALYTE: Adenovirus (0410)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Orion Diagnostica Diarlex Rota-Adeno (dir.

antigen/visual) (46154)

ANALYTE: Rotavirus (5509)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Abbott TestPack Rotavirus (direct antigen/

visual) (04516)

Meridian Diagnostics ImmunoCard

Rotavirus (40189)

Orion Diagnostica Diarlex Rota-Adeno (dir.

antigen/visual) (46154)

COMPLEXITY: High

SPECIALITY/SUBSPECIALITY: Bacteriology

ANALYTE: Aerobic &/or Anaerobic

Organisms-unlimited sources (0412)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Alamar Bacterial Identification Panel

(including culture) (04531)

Analytab API 20E/UniScept 20E (including

culture) (04513)

Becton Dickinson Crystal E/NF ID System

(including culture) (07485)

Becton Dickinson Crystal RS/E ID System

(including culture) (07484)

Micro Media Sys. Microdilution MIC/ID

Panels (inc. culture) (40201)

Radiometer Microbat 12A & 12A∂12B G/

neg ID Sys (inc. cult.) (55115)

Roche Oxi/Ferm II (including culture)

(55116)

Vitek Systems Rapid NFT (including

culture) (67076)

ANALYTE: Aerobic Organisms from urine

specimens only (0468)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Adams Scientific Selecticult-U

(nonconfirmatory ID) (04548)

BioClinical Systems Bullseye Urine Plate

(nonconfirm. ID) (07539)

Culture Kits, Inc. Uri-Three

(nonconfirmatory ID) (10262)

Future Medical Tech. Intl. Qualture

(nonconfirmatory ID) (19022)

Innovative Diag. Systems IDS Rapid SS/U

(including culture) (28053)

Troy Biologicals Bacti-Star II Urine Sys.

(nonconfirm. ID) (61142)

Troy Biologicals Bacti-Star Urine Plate

(nonconfirm. ID) (61143)

Troy Biologicals Bacti-Urine Plate

(nonconfirmatory ID) (61144)

Troy Biologicals Uri-Check Plus

(nonconfirmatory ID) (61145)

UTI-tect Bacteriuria Diag. Test System

(nonconfirmatory ID) (64028)

ANALYTE: Chlamydia (1016)

TEST SYSTEM, ASSAY OR

EXAMINATION:

DAKO IDEIA Chlamydia (direct Ag/

spectrophoto) (13329)

DAKO IDEIA Chlamydia (direct Ag/visual)

(13328)

DAKO IMAGEN Chlamydia (direct antigen)

(13334)

Gen-Probe PACE 2C System (22171)

Gen-Probe Pace2 Probe Competition Assay

(PCA) (dir. Ag) (22166)

NeoGenex C. trachomatis Antigen Test

(direct antigen) (43099)

NeoGenex C. trachomatis Antigen Test

(inc. cell culture) (43098)

Roche Amplicor Chlamydia Trachomatis

Test (55118)

Sanofi Pasteur Chlamydia Micro. EIA

Blocking (dir.ag/spec.) (58330)

Sanofi Pasteur Chlamydia Microplate EIA

(dir. ag./spectro.) (58336)

Syva MicroTrak II Chlamydia EIA Blocking

Assay (dir.ag/spec) (58335)

ANALYTE: Clostridium difficile (1022)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Alexon ProSpecT Clostridium difficile

(direct Ag/spectro) (04540)

Alexon ProSpecT Clostridium difficile

(direct Ag/visual) (04539)

Becton Dickinson CULTURETTE BRAND

Toxin CD (dir. Ag/visual) (07486)

Becton Dickinson CULTURETTE BRAND

Toxin CD (dir. Ag/Spectro) (07487)

TechLab C. difficile 1-hour TOX–A Test

(spectrophotometric) (61149)

TechLab C. difficile 1-hour TOX–A Test

(visual) (61148)

TechLab C. difficile Toxin/Antitoxin Kit

(61107)

TechLab Clostridium difficile TOX–B Test

(61147)

ANALYTE: Dental plaque (1317)

TEST SYSTEM, ASSAY OR

EXAMINATION:

BioScan Video Phase Contrast Microscope

(07499)

ANALYTE: Escherichia coli (1604)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Remel E. coli 0157:H7 Latex Test

(including culture) (55125)

ANALYTE: Legionella (3706)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Binax Legionella Urinary Antigen EIA

(07527)

ANALYTE: N. gonorrhoeae (from urogenital

or rectal only) (4317)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Gen-Probe PACE 2C System (22171)

ANALYTE: Neisseria gonorrhoeae (4302)

TEST SYSTEM, ASSAY OR

EXAMINATION:

E–Y Laboratories Gonochek–II Kit (16027)

ANALYTE: Salmonella (5802)

TEST SYSTEM, ASSAY OR

EXAMINATION:

SMI MED. Salmonella O Grouping

(including culture) (58255)

ANALYTE: Staphyococcus (5807)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Trinity Laboratories STAPH–A–LEX

System (including Culture) (61129)

Unipath Staphytect–OD (including culture)

(64030)

ANALYTE: Streptococcus pneumoniae

(5808)

TEST SYSTEM, ASSAY OR

EXAMINATION:

AB Biodisk Etest for S. pneumoniae

(including culture) (04561)

ANALYTE: Streptococcus, group A (5810)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Becton Dickinson Precise STREP A

(including culture) (07427)

Gen-Probe Group A Streptococcus Direct

Test (22165)
Federal Register / Vol. 60, No. 93 / Monday, May 15, 1995 / Notices 25965

Pro-lab Prolex Streptococcal Grouping

Latex (inc. culture) (49116)

Remel RIM Strep Grouping LA Test

(including culture) (55139)

Syntron QuikPac Strep A (EIA) Test

(including culture) (58293)

ANALYTE: Streptococcus, group B (5811)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Pacific Biotech Cards O.S. Strep B.

(including culture) (49115)

Pro-Lab Prolex Streptococcal Grouping

Latex (inc. culture) (49116)

Remel RIM Strep Grouping LA Test

(including culture) (55139)

ANALYTE: Streptococcus, group C (5812)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Pro-Lab Prolex Streptococcal Grouping

Latex (inc. culture) (49116)

Remel RIM Strep Grouping LA Test

(including culture) (55139)

ANALYTE: Streptococcus, group D (5813)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Pro-Lab Prolex Streptococcal Grouping

Latex (inc. culture) (49116)

ANALYTE: Streptococcus, group F (5814)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Pro-Lab Prolex Streptococcal Grouping

Latex (inc. culture) (49116)

Remel RIM Strep Grouping LA Test

(including culture) (55139)

ANALYTE: Streptococcus, group G (5815)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Pro-Lab Prolex Streptococcal Grouping

Latex (inc. culture) (49116)

Remel RIM Strep Grouping LA Test

(including culture) (55139)

SPECIALITY/SUBSPECIALITY:

Endocrinology

ANALYTE: 17 OH Progesterone, Neonatal

(0103)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Wallac Oy DELFIA Neo-17a-OHP Kit

(70157)

ANALYTE: 17 alpha-OH Progesterone (0109)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Pantex NeoScreen ELISA 17 alphaHydroxyprogesterone (49124)

ANALYTE: 5-Hydroxyindolacetic Acid,

Urine (5-HIAA) (0101)

TEST SYSTEM, ASSAY OR

EXAMINATION:

esa Coulochem Electrode Array System

(CEAS) (16043)

ANALYTE: Adrenocorticotropic Hormone

(ACTH) (0458)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Nichols Institute Chemiluminescence

ACTH Assay (43074)

ANALYTE: Aldosterone (0459)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Diagnostic Systems DSL Active

Aldosterone RIA Kit (13315)

ANALYTE: Catecholamines, Urine (1055)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Bioanalytical Systems Urinary

Catecholamine Kit (07560)

ANALYTE: Cortisol (1032)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Nichols Institute Chemiluminescence

Cortisol Assay (43082)

Wallac Oy DELFIA Cortisol Kit (70159)

elias usa Synelisa Cortisol (16048)

ANALYTE: Cortisol, Urine (extraction

procedure) (1095)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Abbott TDX (04071)

Abbott TDX FLx (04072)

Sanofi Pasteur Access Immunoassay

System (58257)

Vitek Systems Vidas (67038)

ANALYTE: Dehydroepiandrosterone (DHEA)

(1309)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Diagnositic Systems DSL–9000 Active

DHEA RIA Kit (13309)

Nichols Institute Chemiluminescence

DHEA Assay (43079)

elias usa Synelisa DHEA Sulfate EIA Kit

(16062)

ANALYTE: Dehydroepiandrosterone Sulfate

(DHEA-SO4) (1310)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Nichols Institute Chemiluminescence

DHEA-S Assay (43083)

ANALYTE: Erythropoietin (1611)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Genzyme Predicta Erythropoietin Kit

(22159)

Nichols Institute Cheiluminescence

Erythropoietin Assay (43100)

R & D Systems Quantikine Erythropoietin

ELISA (55114))

R & D Systems Quantikine IVD

Erythropoietin ELISA (55132)

ANALYTE: Estradiol (1605)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Bio-Rad CoTube (07138)

Clinical Assays GammaCoat (10060)

Diagnostic Products Corp. Coat-a-Count

Estradiol-6 (13317)

Wallac Oy DELFIA Estradiol Kit (70148)

ANALYTE: Estrone (1628)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Diagnostic Systems Estrone RIA Kit

(13314)

ANALYTE: Follicle Stimulating Hormone

(FSH) (1908)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Nichols Institute Chemiluminescence FSH

Assay (43066)

Roche Cobas Core FSH EIA (manual

procedure) (55124)

SeaLite Sciences AquaLite FSH (58342)

Wallac Oy DELFIA hFSH Kit (70149)

ANALYTE: HCG, Beta, Serum, Quantitative

(2502)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Nichols Institute Chemiluminescence HCG

Assay (43081)

SeaLite Sciences AquaLite hCG (58340)

Wallac Oy DELFIA hCG Kit (70147)

ANALYTE: Homovanillic Acid (HVA) (2545)

TEST SYSTEM, ASSAY OR

EXAMINATION:

esa Coulochem Electrode Array System

(CEAS) (16043)

ANALYTE: Human Growth Hormone (GH)

(2547)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Nichols Institute Chemiluminescence HGH

Assay (43068)

Wallac Oy DELFIA hGH Kit (70162)

ANALYTE: Insulin-like Grwth Factor Bind.

Protein3 (IGFBP–3) (2832)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Diagnostic Systems Active IGFBP–3 IRMA

Kit (13375)

Diagnostic Systems DSL–6700 IGFBP–3

RIA Kit (13310))

Endocrine Sciences IGFBP–3 RIA Kit

(16060)

ANALYTE: Luteinizing Hormone (LH) (3713)

TEST SYSTEM, ASSAY OR

EXAMINATION:

ICN ImmuChem LH–MW Elisa Kit (28269)

Roche Cobas Core LH EIA (manual

procedure) (55121)

SeaLite Sciences AquaLite LH (58339)

Wallac Oy DELFIA hLH Kit (70150)

Wallac Oy DELFIA hLH Spec Kit (70151)

ANALYTE: Parathyroid Hormone—Intact

(4924)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Bio-Rad CoTube (07138)

Diagnostic Products Corp. Coat-A-Count

(13030)

Immunodiagnostic Systems ltd GammaBCT Intact PTH (28351)

Immunodiagnostic Systems ltd OCTEIA

Intact PTH (28350)

Nichols Institute Chemiluminescence PTH

Assay (43080)

ANALYTE: Progesterone (4914)

TEST SYSTEM, ASSAY OR

EXAMINATION:

CyberFluor FIAgen Progesterone Assay Kit

(10261)

Immunotech Progesterone RIA Kit (28325)

Wallac Oy DELFIA Progesterone Kit

(70153)

elias usa Synelisa Progesterone (16046)

ANALYTE: Prolactin (4915)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Abbott RIA Bead (04061)

Nichols Institute Chemiluminescence

Prolactin Assay (43069)

Roche Cobas Core Prolactin EIA (manual

procedure) (55122)

Wallac Oy DELFIA Prolactin Kit (70152)

ANALYTE: Renin (5515)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Nichols Institute BV Active Renin RIA

(43062)

ANALYTE: Sex Hormone Binding Globulin

(5819)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Wallac Oy DELFIA SHBG Kit (70154)

ANALYTE: Testosterone (6102)
25966 Federal Register / Vol. 60, No. 93 / Monday, May 15, 1995 / Notices

TEST SYSTEM, ASSAY OR

EXAMINATION:

Wallac Oy DELFIA Testosterone Kit

(70155)

ANALYTE: Thyroid Stimulating Hormone

(TSH) (6106)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Nichols Institute Chemiluminescence TSH

Assay (43065)

Roche Cobas Core TSH EIA (manual

procedure) (55129)

STC Diagnostics TSH Micro-Plate EIA

(58308)

SeaLite Sciences AquaLite TSH (58350)

Wallac Oy DELFIA hTSH Kit (70142)

ANALYTE: Thyroid Stimulating Hormone

(TSH) (Neonatal) (6107)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Bioclone ELEGANCE Neonatal TSH ELISA

(computer calculate) (07555)

Bioclone ELEGANCE Neonatal TSH ELISA

(manual calculations) (07554)

Pantex NEOSCREEN ELISA TSH (49126)

Wallac Oy DELFIA Neo-hTSH Kit (70156)

ANALYTE: Thyroxine (T4) (6109)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Abbott Tetrabead-125 (04519)

Becton Dickinson SimulTRAC (07106)

Nichols Institute Chemiluminescence Total

T4 Assay (43070)

Roche Cobas Core T4 EIA (manual

procedure) (55131)

Wallac Oy DELFIA T4 Kit (70145)

ANALYTE: Thyroxine Binding Globulin

(TBG) (6110)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Wallac Oy DELFIA TBG Kit (70146)

ANALYTE: Thyroxine, Free (FT4) (6111)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Immunotech Free T4 RIA Kit (28326)

Nichols Institute Chemiluminescence Free

T4 Assay (43071)

Roche Cobas Core FT4 EIA (manual

procedure) (55128)

STC Diagnostics Free T–4 Micro-Plate EIA

(58289)

Wallac Oy DELFIA Free T4 Kit (70143)

ANALYTE: Triiodothyronine (T3) (6119)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Monobind Coated Tube RIA Test System

(40164)

Nichols Institute Chemiluminescence Total

T3 Assay (43072)

Roche Cobas Core T3 EIA (manual

procedure) (55130)

Wallac Oy DELFIA T3 Kit (70144)

ANALYTE: Triiodothyronine Uptake (T3U)

(TU) (6120)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Nichols Institute Chemiluminescence T3

Uptake Assay (43087)

ANALYTE: Triiodothyronine, Free (FT3)

(6121)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Nichols Institute Chemiluminescence Free

T3 Assay (43078)

ANALYTE: Vanillylmandelic Acid (VMA)

(6710)

TEST SYSTEM, ASSAY OR

EXAMINATION:

esa Coulochem Electrode Array System

(CEAS) (16043)

SPECIALITY/SUBSPECIALITY: General

Chemistry

ANALYTE: 1-Methylhistidine (0107)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Beckman System 6300 Series Amino Acid

Analyzer (07553)

ANALYTE: 3-Methylhistidine (0108)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Beckman System 6300 Series Amino Acid

Analyzer (07553)

ANALYTE: Alanine (0511)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Beckman System 6300 Series Amino Acid

Analyzer (07553)

ANALYTE: Alanine Aminotransferase (ALT)

(SGPT) (0404)

TEST SYSTEM, ASSAY OR

EXAMINATION:

STC Diagnostics ALT Micro-Plate Assay

(58337)

ANALYTE: Albumin (0414)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Trace Scientific Albumin BCG Modified

Reactivity (Manual) (61118)

ANALYTE: Alkaline Phosphatase (ALP)

(0416)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Hybritech Tandem-R Ostase (25170)

Synermed Test Kit (58260)

ANALYTE: Alpha-Amino-n-butyric Acid

(0512)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Beckman System 6300 Series Amino Acid

Analyzer (07553)

ANALYTE: Alpha-Aminoadipic Acid (0510)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Beckman System 6300 Series Amino Acid

Analyzer (07553)

ANALYTE: Aminoethylcysteine (0513)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Beckman System 6300 Series Amino Acid

Analyzer (07553)

ANALYTE: Ammonia, Plasma/Serum (0427)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Bekman System 6300 Series Amino Acid

Analyzer (07553)

ANALYTE: Amylase (0429)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Genzyme Test Kit (22164)

Intersect Systems Test Kit (28321)

Pointe Scientific Manual Amylase Test

(49103)

Synermed Test Kit (58260)

TECO Diagnostics Amylase Reagent Set

(manual procedure) (61156)

ANALYTE: Angiotensin Converting Enzyme

(ACE) (0481)

TEST SYSTEM, ASSAY OR

EXAMINATION:

ALPCO Angiotensin Converting Enzyme

REA (04562)

ANALYTE: Anserine (0514)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Beckman System 6300 Series Amino Acid

Analyzer (07553)

ANALYTE: Apolipoprotein A1 (0462)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Nichols Institute Chemiluminescence

APO–A1 Assay (43077)

ANALYTE: Apolipoprotein B (0457)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Nichols Institute Chemiluminescence

APO–B Assay (43073)

ANALYTE: Arginine (0515)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Beckman System 6300 Series Amino Acid

Analyzer (07553)

ANALYTE: Asparagine (0509)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Beckman System 6300 Series Amino Acid

Analyzer (07553)

ANALYTE: Aspartic Acid (0508)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Beckman System 6300 Series Amino Acid

Analyzer (07553)

ANALYTE: Beta-Alanine (0732)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Beckman System 6300 Series Amino Acid

Analyzer (07553)

ANALYTE: Beta-Aminoisobutyric Acid

(0733)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Beckman System 6300 Series Amino Acid

Analyzer (07553)

ANALYTE: Bilirubin, Direct (0704)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Horizon Direct Bilirubin Manual Procedure

(25151)

Synermed Test Kit (58260)

ANALYTE: Carbon Dioxide, Total (C02)

(1003)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Intersect Systems Test Kit (28321)

ANALYTE: Carnosine (1108)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Beckman System 6300 Series Amino Acid

Analyzer (07553)

ANALYTE: Cholesterol (1020)

TEST SYSTEM, ASSAY OR

EXAMINATION:

King Diagnostics Test Kit (34051)

Randox Laboratories Test Kit (55106)

ANALYTE: Cholyglycine (Bile Acids) (1053)

TEST SYSTEM, ASSAY OR

EXAMINATION:
Federal Register / Vol. 60, No. 93 / Monday, May 15, 1995 / Notices 25967

Abbott CG RIA Kit (04517)

ANALYTE: Citrulline (1105)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Beckman System 6300 Series Amino Acid

Analyzer (07553)

ANALYTE: Creatine Kinase (CK) 1034)

TEST SYSTEM, ASSAY OR

EXAMINATION:

King Diagnostics Test Kit (34051)

Pointe Scientific Manual Creatine Kinase

Test (49104)

Randox Laboratories CK NAC-activated

Test Kit (55117)

Synermed Test Kit (58260)

ANALYTE: Creatine Kinase Isoenzymes (CK

Isoenzymes) (1052)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Helena Laboratories REP E–Z CK–30

Isoenzyme Procedure (25153)

ANALYTE: Creatine Kinase MB Fraction

(CKMB) (1002)

TEST SYSTEM, ASSAY OR

EXAMINATION:

CHEMROY Creatine Kinase-MB (CK–MB)

Reagent Set (10280)

Diagnostic Chemicals Ltd. Assay Kit

(13210)

Helena Laboratories Cardio REP CK

Isoenzyme Procedure (25139)

Helena Laboratories Cardio REP CK

Isoforms Procedure (25140)

Pointe Scientific Creatine Kinase-MB

(manual procedure) (49117)

ANALYTE: Creatinine (1035)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Synermed Test Kit (58260)

ANALYTE: Cystathionine (1107)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Beckman System 6300 Series Amino Acid

Analyzer (07553)

ANALYTE: Cystine (1106)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Beckman System 6300 Series Amino Acid

Analyzer (07553)

ANALYTE: Ethanolamine (1629)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Beckman System 6300 Series Amino Acid

Analyzer (07553)

ANALYTE: Ferritin (1902)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Nichols Institute Chemiluminescence

Ferritin Assay (43067)

Roche Cobas Core Ferritin EIA (manual

procedure) (55123)

Wallac Oy DELFIA Ferritin Kit (70161)

ANALYTE: Folate (Folic acid) (1907)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Bio-Rad Quantaphase II (07532)

ANALYTE: Gamma Glutamyl Transferase

(GGT) (2201)

TEST SYSTEM, ASSAY OR

EXAMINATION:

King Diagnostics Test Kit (34051)

Synermed Test Kit (58260)

ANALYTE: Gamma-Aminobutyric Acid

(2220)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Beckman System 6300 Series Amino Acid

Analyzer (07553)

ANALYTE: Glutamic Acid (2217)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Beckman System 6300 Series Amino Acid

Analyzer (07553)

ANALYTE: Glutamine (2218)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Beckman System 6300 Series Amino Acid

Analyzer (07553)

ANALYTE: Glycine (2219)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Beckman System 6300 Series Amino Acid

Analyzer (07553)

ANALYTE: Glycosylated Hemoglobin (Hgb

A1C) (2204)

TEST SYSTEM, ASSAY OR

EXAMINATION:

LSI ASCA Chemistry System (37069)

Pointe Scientific Glycohemoglobin Test Kit

(49114)

Primus Rapid Gel Glycated Hemoglobin

(49129)

TECO Glycohemoglobin Kit (61141)

ANALYTE: HDL Cholesterol (2550)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Abbott Spectrum CCX (04515)

Beckman Synchron CX 5 CE (07491)

Boehringer Mannheim Hitachi 914 (07546)

Du Pont ACA Star (13357)

Du Pont Dimension XL (13355)

Intersect Systems Test Kit (28321)

Olympus AU 5041 (46145)

Olympus AU 5121 (46087)

Olympus AU 5200 (46143)

Technicon OPERA Clinical Chemistry

System (61161)

ANALYTE: Hemoglobin C (2559)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Isolab HemoCard Hemoglobin C Assay

(28340)

ANALYTE: Hemoglobin E (2556)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Isolab HemoCard Hemoglobin E (28268)

ANALYTE: Hemoglobin Fractions (2544)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Helena Laboratories REP Alkaline Hb-15

(25144)

ANALYTE: Hemoglobin S (2536)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Bio-Rad Variant (07498)

Isolab Quik-Sep Quantitative Hemoglobin

S Assay (28353)

ANALYTE: Histidine (2563)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Beckman System 6300 Series Amino Acid

Analyzer (07553)

ANALYTE: Homocystine (2561)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Beckman System 6300 Series Amino Acid

Analyzer (07553)

ANALYTE: Hydroxylysine (2562)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Beckman System 6300 Series Amino Acid

Analyzer (07553)

ANALYTE: Hydroxyproline (2560)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Beckman System 6300 Series Amino Acid

Analyzer (07553)

ANALYTE: Iron (2814)

TEST SYSTEM, ASSAY OR

EXAMINATION:

King Diagnostics Test Kit (34051)

Sigma Diagnostics Test Kit (58051)

ANALYTE: Iron Binding Capacity (post

saturation/separation) (2815)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Abbott Spectrum CCX (04515)

Beckman Synchron CX 5 CE (07491)

Boehringer Mannheim Hitachi 914 (07546)

Du Pont ACA Star (13357)

Du Pont Dimension XL (13355)

King Diagnostics Test Kit (34051)

Kodak Ektachem 550 XRC Analyzer

(34056)

Kodak Ektachem 700 Analyzer C Series

(34054)

Kodak Ektachem 750 XRC Analyzer

(34055)

Kodak Ektachem 950 IRC (34087)

LSI ASCA Chemistry System (37069)

Olympus AU 5041 (46145)

Olympus AU 5200 (46143)

ANALYTE: Iron Binding Capacity, Unsat.

(UIBC) no pretreat. (2823)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Sigma Diagnostics Test Kit (58051)

ANALYTE: Isoleucine (2833)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Beckman System 6300 Series Amino Acid

Analyzer (07553)

ANALYTE: Lactate Dehydrogenase (LDH)

(3701)

TEST SYSTEM, ASSAY OR

EXAMINATION:

HiChem LDH/L Reagent Kit (manual)

(25183)

ANALYTE: Lactate Dehydrogenase

Isoenzymes (3721)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Helena Laboratories Cardio REP LD

Isoenzyme Procedure (25169)

ANALYTE: Leucine (3749)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Beckman System 6300 Series Amino Acid

Analyzer (07553)

ANALYTE: Lipase (3711)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Meditech Diagnostic System Test Kit

(40118)

NuClin Diagnostics ElIpAse (43090)

Sigma Diagnostics Lipase-PS (manual

procedure) (58323)

ANALYTE: Lipoprotein Fractions (3720)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Helena Laboratories REP Direct-Sep

Cholesterol (25179)
25968 Federal Register / Vol. 60, No. 93 / Monday, May 15, 1995 / Notices

Helena Laboratories REP HDL/LDL–30

Electrophoresis System (25168)

ANALYTE: Lysine (3750)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Beckman System 6300 Series Amino Acid

Analyzer (07553)

ANALYTE: Magnesium (4002)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Horizon Diagnostics Magnesium (manual

procedure) (25178)

King Diagnostics Test Kit (34051)

ANALYTE: Methionine (4031)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Beckman System 6300 Series Amino Acid

Analyzer (07553)

ANALYTE: Microalbumin (4019)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Synermed IR 500 (58322)

ANALYTE: Microprotein, CSF (4026)

TEST SYSTEM, ASSAY OR

EXAMINATION:

DMA Test Kit (13216)

Sterling Diagnostics Test Kit (58230)

ANALYTE: Microprotein, Urine (4027)

TEST SYSTEM, ASSAY OR

EXAMINATION:

DMA Test Kit (13216)

Sterling Diagnostics Test Kit (58230)

TRACE Scientific Test Kit (61044)

ANALYTE: Ornithine (4606)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Beckman System 6300 Series Amino Acid

Analyzer (07553)

ANALYTE: Phenylalanine (4942)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Beckman System 6300 Series Amino Acid

Analyzer (07553)

ICN ImmuChem Phenylalanine Microwell

Enzyme Assay (28384)

Porton Cambridge Quantase Phenylalanine

Assay (49125)

ANALYTE: Phosphoethanolamine (4970)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Beckman System 6300 Series Amino Acid

Analyzer (07553)

ANALYTE: Phosphoserine (4969)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Beckman System 6300 Series Amino Acid

Analyzer (07553)

ANALYTE: Proline (4971)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Beckman System 6300 Series Amino Acid

Analyzer (07553)

ANALYTE: Protein, Glycated (4963)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Diagnostic Specialties Protein-Bound

Glucose Assay Kit (13286)

ANALYTE: Protein, Total (4921)

TEST SYSTEM, ASSAY OR

EXAMINATION:

STC Diagnostics Total Protein Micro-Plate

Assay (58347)

ANALYTE: Proteolytic enzymes (4965)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Advanced Clinical Tech. Periocheck

Enzyme Activity Kit (04526)

ANALYTE: Sarcosine (5835)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Beckman System 6300 Series Amino Acid

Analyzer (07553)

ANALYTE: Serine (5834)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Beckman System 6300 Series Amino Acid

Analyzer (07553)

ANALYTE: Surfactant/Albumin Ratio

(5833)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Abbott TDX (04071)

Abbott TDX FLx (04072)

ANALYTE: Taurine (6141)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Beckman System 6300 Series Amino Acid

Analyzer (07553)

ANALYTE: Threonine (6141)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Beckman System 6300 Series Amino Acid

Analyzer (07553)

ANALYTE: Transferrin (6114)

TEST SYSTEM, ASSAY OR

EXAMINATION:

TRACE Scientific Test Kit (61044)

ANALYTE: Triglyceride (6118)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Randox Laboratories Test Kit (55106)

ANALYTE: Trypsin (6129)

TEST SYSTEM, ASSAY OR

EXAMINATION:

NuClin Diagnostics NuCliTryp RIA (43089)

ANALYTE: Tryptophan (6144)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Beckman System 6300 Series Amino Acid

Analyzer (07553)

ANALYTE: Tyrosine (6143)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Beckman System 6300 Series Amino Acid

Analyzer (07553)

ANALYTE: Urea (BUN) (6403)

TEST SYSTEM, ASSAY OR

EXAMINATION:

AMRESCO BUN Reagent (manual

procedure) (04554)

Beckman System 6300 Series Amino Acid

Analyzer (07553)

ANALYTE: Uric Acid (6404)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Randox Laboratories Test Kit (55106)

Synermed Test Kit (58260)

ANALYTE: Valine (6717)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Beckman System 6300 Series Amino Acid

Analyzer (07553)

ANALYTE: Vitamin B12 (6707)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Bio-Rad Quantaphase II (07532)

SPECIALITY/SUBSPECIALITY: General

Immunology

ANALYTE: Allergen Specific NgE (0417)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Ciba Corning Magic Lite SQ Specific IgE

Immunoassay (10245)

Hycor Biomedical Specific IgE EIA–

TURBO (25146)

Hycor Biomedical Specific IgE RIA Isotope

Unit (25145)

Hycor Ultra-EIA Specific IgE Assay (25166)

MAST CLA Allergy System (densitometer)

(40176)

MAST CLA–1 Chemiluminescent Allergy

System (40177)

ANALYTE: Alpha-1-Acid Glycoprotein

(orosomucoid) (0420)

TEST SYSTEM, ASSAY OR

EXAMINATION:

The Binding Site BIND A RID Human

Alpha-1 Acid Glycoprotein (61140)

ANALYTE: Anti-Arbovirus Antibodies (0498)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Hillcrest Biologicals Arbovirus (IgG) IFA

Test (25141)

Hillcrest Biologicals Arbovirus (IgM) IFA

Test (25142)

ANALYTE: Anti-Cardiolipin Antibodies

(0434)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Hemagen Cardiolipin Antibody Kit (25150)

INOVA Diagnostics QUANTA Lite ACA

Screen (28234)

INOVA Diagnostics QUANTA Lite IgA

ACA (28233)

Immuno Concepts Anticardiolipin Ab

Screening Test System (28280)

Louisville APL Diagnostics ApHL ELISA

Kit (37071)

Shield Diagnostics DIASTAT Total AntiCardiolipin Kit (58295)

elias usa Synelisa Cardiolipin Abs (IgA)

(16055)

elias usa Synelisa Cardiolipin Abs (IgG)

(16056)

elias usa Synelisa Cardiolipin Abs (IgM)

(16057)

elias usa elias Cardiolipin (IgA) Abs EIA

(qualitative) (16066)

elisa usa elias Cardiolipin (IgA) Abs EIA

(semiquantitative) (16067)

ANALYTE: Anti-Centromere Antibodies

(0487)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Shield Diagnostics DIASTAT AntiCentromere Kit (58312)

elias usa Synelisa ANA Profile (16058)

elias usa Synelisa Centromere Abs (16047)

elias usa Synelisa ENA Screen (qualitative)

(16064)

elias usa Synelisa ENA Screen

(semiquantitative) (16065)

elias usa Varelisa Centromere Antibodies

(qualitative) (16085)

elias usa Varelisa Centromere Antibodies

(semi-quant.) (16086)

ANALYTE: Anti-DNA Antibodies (0435)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Cambridge Life Sciences AUTOZYME

(10206)
Federal Register / Vol. 60, No. 93 / Monday, May 15, 1995 / Notices 25969

Cambridge Life Sciences AUTOZYME

Screen (10263)

Cambridge Life Sciences SELISA AntinDNA Ab Kit (10264)

Clark Laboratories Encore dsDNA EIA Test

(10238)

Helix Diagnostics EIA Anti-dsDNA Test

(25171)

Immco Diagnostics Anti-dsDNA Antibody

Test (28276)

Immco Diagnostics Anti-native DNA

Antibody Test (28312)

Sigma Anti-dsDNA Kit (58346)

The Binding Site BINDAZYME a-dsDNA

EIA Kit (61112)

The Binding Site Crithidia luciliae dsDNA

Kit (61109)

Zeus Autoantibody Profile-6 ELISA Test

System (79042)

elias usa Synelisa dsDNA Antibodies

(16019)

elias usa elias dsDNA Abs EIA Kit (16031)

ANALYTE: Anti-ENA Antibodies (0507)

TEST SYSTEM, ASSAY OR

EXAMINATION:

INOVA Diagnostics QUANTA Lite ENA 5

ELISA (28365)

Shield Diagnostics DIASTAT ENA Single

Well Screen Kit (58345)

Zeus ENA Screen ELISA Test System

(79044)

ANALYTE: Anti-Endomysial Antibodies

(EMA) (0497)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Immco Diagnostics Anti-Endomysial

Antibody (EMA) Test (28281)

ANALYTE: Anti-Histone Antibodies (0437)

TEST SYSTEM, ASSAY OR

EXAMINATION:

BioWhittaker RheumELISA II (07488)

Cambridge Life Sciences AUTOZYME

Screen (10263)

INOVA Diagnostics QUANTA Lite Histone

ELISA (28332)

Immco Diagnostics ImmuLisa Anti-Histone

Ab ELISA (28354)

elias usa Synelisa Histone Antibodies EIA

Kit (16041)

ANALYTE: Anti-Jo-1 (0438)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Advanced Biological Products ELISA–

DOXA Combi-6 (04504)

Advanced Biological Products ELISA–

DOXA Jo-1 (04503)

BioWhittaker RheumELISA II (07488)

Cambridge Life Sciences AUTOZYME

(10206)

Hemagen ENA Screen 6 Kit (25160)

Hemagen Jo-1 ENA Kit (qualitative) (25190)

Hemagen Jo-1 ENA Kit (semi-quantitative)

(25195)

INOVA Diagnostics QUANTA Lite Jo-1

ELISA (28273)

Immuno Concepts RELISA ENA Antibody

Screening Test (28330)

Molecular Immunodiagnostics Jo-1 EIA

Test Kit (40182)

The Binding Site ENA Screening CIE Kit

(61114)

Zeus ENA Profile-6 ELISA Test System

(79045)

elias usa Synelisa ANA Profile (16058)

elias usa Synelisa ENA Screen (qualitative)

(16064)

elias usa Synelisa ENA Screen (semiquantitative) (16065)

elias usa Synelisa Jo-1 Antibodies EIA Kit

(16038)

elias usa Varelisa Jo-1 Antibodies

(qualitative) (16081)

elias usa Varelisa Jo-1 Antibodies (semiquantitative) (16082)

ANALYTE: Anti-Mitochondrial Antibodies

(AMTA) (0439)

TEST SYSTEM, ASSAY OR

EXAMINATION:

INOVA Diagnostics QUANTA Lite

Mitochondria M2 ELISA (28270)

Immco Diagnostics Autoantibody Test

System (28311)

elias usa Synelisa M2 Antibodies EIA Kit

(16036)

ANALYTE: Anti-Myeloperoxidase (MPO)

Antibodies (0505)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Shield Diagnostics DIASTAT Anti-MPO

(qualitative) (58331)

Shield Diagnostics DIASTAT Anti-MPO

(semi-quantitative) (58332)

ANALYTE: Anti-Neutrophil Cytoplasm

Antibodies (0440)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Shield Diagnostics DIASTAT Anti-PR3

(cANCA) (58329)

ANALYTE: Anti-Nuclear Antibodies (ANA)

(0441)

TEST SYSTEM, ASSAY OR

EXAMINATION:

INOVA Diagnostics QUANTA Lite ENA 4

ELISA (28235)

Immco Diagnostics Autoantibody Test

System (28311)

Immuno Concepts HEp-2000 Fluorescent

ANA Test System (28366)

Light Diag. ANA Test Kit with Mouse Liver

Substrate (37097)

Light Diag. ANA Test Kit with Rat Liver

Substrate (37098)

Shield Diagnostics Anti-Nuclear Antibody

(ANA) Kit (58313)

Tissue Culture Biotec ANA Test System

(61108)

Zeus ANA Screen ELISA (79043)

elias usa ANA Total EIA Kit (16063)

elias usa Synelisa ANA Total (16054)

elias usa Synelisa ANA–8 Screen (16074)

elias usa Varelisa ANA–8 Screen (16071)

ANALYTE: Anti-Parietal Cell Antibodies

(0442)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Immco Diagnostics Autoantibody Test

System (28311)

elias usa Synelisa Parietal Cell Antibodies

EIA Kit (16040)

ANALYTE: Anti-RNP (Ribonucleoprotein)

(0443)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Advanced Biological Products ELISA–

DOXA Combi-4 (04505)

Advanced Biological Products ELISA–

DOXA Combi-6 (04504)

Advanced Biological Products ELISA–

DOXA Sm/RNP Kit (04506)

Apotex ANA Profile I (04507)

Cambridge Life Sciences AUTOZYME

(10206)

Cambridge Life Sciences AUTOZYME

Screen (10263)

Clark Laboratories ENA Combined Test Kit

(10255)

Clark Laboratories Encore Sm/RNP Antigen

EIA Test (10240)

Helix Diagnostics EIA Extractable Nuclear

Antigen Test (25157)

Hemagen ENA Screen 6 Kit (25160)

INOVA Diagnostics QUANTA Lite RNP

ELISA (28236)

Immco Diagnostics Anti-ENA Antibody

Test (28317)

Immco Diagnostics Anti-RNP and Anti-Sm

Antibody Test (28314)

Immunco Concepts RELISA ENA Antibody

Screening Test (28330)

Molecular Immunodiagnostics RNP EIA

Test Kit (40184)

The Binding Site ENA Screening CIE Kit

(61114)

Zeus Autoantibody Profile-6 ELISA Test

System (79042)

Zeus ENA Profile-6 ELISA Test System

(79045)

elias usa Synelisa ENA Screen (qualitative)

(16064)

elias usa Synelisa ENA Screen

(semiquantitative) (16065)

elias usa Synelisa Sm Abs/RNP-Sm Abs

(16037)

ANALYTE: Anti-RNP-Sm Antibodies (0502)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Helix Diagnostics Anti-SM/RNP EIA

Antibody Test (25165)

elias usa Synelisa ANA Profile (16058)

elias usa Varelisa RNP-Sm Antibodies

(qualitative) (16079)

elias usa Varelisa RNP-Sm Antibodies

(semi-quantitative)(16080)

ANALYTE: Anti-Reticulin Antibodies (0444)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Immco Diagnostics Anti-Reticulin

Antibody (ARA) Test (28331)

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

TEST SYSTEM, ASSAY OR

EXAMINATION:

Advanced Biological Products ELISA–

DOXA Combi-4 (04505)

Advanced Biological Products ELISA–

DOXA Combi-6 (04504)

Advanced Biological Products ELISA–

DOXA SSb Kit (04510)

Apotex ANA Profile I (04507)

Cambridge Life Sciences AUTOZYME

(10206)

Cambridge Life Sciences AUTOZYME

Screen (10263)

Clark Laboratories ENA Combined Test Kit

(10255)

Clark Laboratories Encore SS–A Antigen

EIA Test (10241)

Helix Diagnostics Anti–SS–A/Ro EIA

Antibody Test (25148)

Helix Diagnostics EIA Extractable Nuclear

Antigen Test (25157)

Hemagen ENA Screen 6 Kit (25160)

Hemagen SS–A (Ro) ENA Kit (qualitative)

(25187)

Hemagen SS–A (Ro) ENA Kit (semiquantitative) (25192)
25970 Federal Register / Vol. 60, No. 93 / Monday, May 15, 1995 / Notices

INOVA Diagnostics QUANTA Lite SS–A

ELISA (28238)

Immco Diagnostics Anti-ENA Antibody

Test (28317)

Immco Diagnostics Anti–SS–A(Ro) and

Anti–SS–B(La) Test (28315)

Immuno Concepts RELISA ENA Antibody

Screening Test (28330)

Molecular Immunodiagnostics Ro EIA Test

Kit (40183)

The Binding Site ENA Screening CIE Kit

(61114)

Zeus Autoantibody Profile-6 ELISA Test

System (79042)

Zeus ANA Profile-6 ELISA Test System

(79045)

elias usa Synelisa ANA Profile (16058)

elias usa Synelisa ENA Screen (qualitative)

(16064)

elias usa Synelisa ENA Screen

(semiquantitative) (16065)

elias usa Synelisa Ro-Abs/La-Abs (16042)

elias usa Varelisa SS–A/Ro Antibodies

(qualitative) (16091)

elias usa Varelisa SS–A/Ro Antibodies

(semi-quantitative) (16092)

ANALYTE: Anti–SS–B/La (0447)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Advanced Biological Products ELISA–

DOXA Combi-4 (04505)

Advanced Biological Products ELISA–

DOXA Combi–6 (04504)

Advanced Biological Products ELISA–

DOXA SSb Kit (04510)

Apotex ANA Profile I (04507)

Cambridge Life Sciences AUTOZYME

(10206)

Clark Laboratories ENA Combined Test Kit

(10255)

Clark Laboratories Encore SS–B Antigen

EIA Test (10243)

Helix Diagnostics Anti–SS–B/La EIA

Antibody Test (25147)

Helix Diagnostics EIA Extractable Nuclear

Antigen Test (25157)

Hemagen ENA Screen 6 Kit (25160)

Hemagen SS–B (La) ENA Kit (qualitative)

(25186)

Hemagen SS–B (La) ENA Kit (semiquantitative) (25191)

INOVA Diagnostics QUANTA Lite SS–B

ELISA (28239)

Immco Diagnostics Anti-ENA Antibody

Test (28317)

Immco Diagnostics Anti–SS–A(Ro) and

Anti–SS–B(La) Test (28315)

Immuno Concepts RELISA ENA Antibody

Screening Test (28330)

Molecular Immunodiagnostics Ro EIA Test

Kit (40186)

The Binding Site ENA Screening CIE Kit

(61114)

Zeus Autoantibody Profile-6 ELISA Test

System (79042)

Zeus ANA Profile-6 ELISA Test System

(79045)

elias usa Synelisa ANA Profile (16058)

elias usa Synelisa ENA Screen (qualitative)

(16064)

elias usa Synelisa ENA Screen

(semiquantitative) (16065)

elias usa Synelisa Ro-Abs/La-Abs (16042)

elias usa Varelisa SS–B/Ro Antibodies

(qualitative) (16089)

elias usa Varelisa SS–B/Ro Antibodies

(semi-quantitative) (16090)

ANALYTE: Anti-Sal-70 (0448)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Advanced Biological Products ELISA–

DOXA Combi–6 (04504)

Advanced Biological Products ELISA–

DOXA Scl70 Kit (04511)

BioWhittaker RheumELISA II (07488)

Cambridge Life Sciences AUTOZYME

(10206)

Clark Laboratories ENA Combined Test Kit

(10255)

Hemagen ENA Screen 6 Kit (25160)

Hemagen Scl-70 ENA Kit (qualitative)

(25188)

Hemagen Scl-70 ENA Kit (semiquantitative) (25193)

INOVA Diagnostics QUANTA Lite Scl-70

ELISA (28274)

Immco Diagnostics Anti-Scl-70 Antibody

Test (28316)

Immuno Concepts RELISA ENA Antibody

Screening Test (28330)

Molecular Immunodiagnostics Scl-70 EIA

Test Kit (40181)

The Binding Site ENA Screening CIE Kit

(61114)

Zeus Autoantibody Profile-6 ELISA Test

System (79042)

Zeus ANA Profile-6 ELISA Test System

(79045)

elias usa Synelisa ANA Profile (16058)

elias usa Synelisa ENA Screen (qualitative)

(16064)

elias usa Synelisa ENA Screen

(semiquantitative) (16065)

elias usa Synelisa Scl-70 Antibodies EIA

Kit (16039)

elias usa Varelisa Scl-70 Antibodies

(qualitative) (16083)

elias usa Varelisa Scl-70 Antibodies (semiquantitative) (16084)

ANALYTE: Anti-Skin Antibodies (0449)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Immco Diagnostics Anti-Skin Antibody

Test (28313)

ANALYTE: Anti-Sm (Smith) (0450)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Advanced Biological Products ELISA–

DOXA Combi-4 (04505)

Advanced Biological Products ELISA–

DOXA Combi–6 (04504)

Advanced Biological Products ELISA–

DOXA Sm Kit (04509)

Advanced Biological Products ELISA–

DOXA Sm/RNP Kit (04506)

Apotex ANA Profile I (04507)

Cambridge Life Sciences AUTOZYME

(10206)

Cambridge Life Sciences AUTOZYME

Screen (10263)

Clark Laboratories ENA Combined Test Kit

(10255)

Clark Laboratories Encore Sm Antigen EIA

Test (10244)

Clark Laboratories Encore Sm/RNP Antigen

EIA Test (10240)

Helix Diagnostics EIA Anti–Sm Ab Test

(25162)

Helix Diagnostics EIA Extractable Nuclear

Antigen Test (25157)

Hemagen ENA Screen 6 Kit (25160)

Hemagen Sm ENA Kit (qualitative) (25196)

Hemagen Sm ENA Kit (semi-quantitative)

(25197)

INOVA Diagnostics QUANTA Lite SM

ELISA (28237)

Immco Diagnostics Anti-ENA Antibody

Test (28317)

Immco Diagnostics Anti–RNP and Anti–

Sm Antibody Test (28314)

Immuno Concepts RELISA ENA Antibody

Screening Test (28330)

Molecular Immunodiagnostics SM EIA

Test Kit (40185)

The Binding Site ENA Screening CIE Kit

(61114)

Zeus Autoantibody Profile-6 ELISA Test

System (79042)

Zeus ANA Profile-6 ELISA Test System

(79045)

elias usa Synelisa ANA Profile (16058)

elias usa Synelisa ENA Screen (qualitative)

(16064)

elias usa Synelisa ENA Screen

(semiquantitative) (16065)

elias usa Synelisa Sm Abs/RNP-Sm Abs

(16037)

elias usa Varelisa Sm Antibodies

(qualitative) (16087)

elias usa Varelisa Sm Antibodies (semiquantitative) (16088)

ANALYTE: Anti-Smooth Muscle Antibodies

(ASMA) (0451)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Immco Diagnostics Autoantibody Test

System (28311)

ANALYTE: Anti-Thyroglobulin Antibodies

(0453)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Biomerica Anti-Thyroglobulin ELISA

(07531)

Clark Laboratories Encore Thyroglobulin

EIA Test (10239)

Cogent Diagnostics AUTOSTAT

Autoantibody Test Kit (10207)

Cogent Diagnostics AUTOSTAT II

Autoantibody Test Kit (10267)

INOVA Diagnostics QUANTA Lite Thyroid

T ELISA (28271)

Immunoprobe Thyroglobulin EIA Test Kit

(28348)

Joldon Diagnostics Thyroglobulin Auto

Antibody EIA Kit (31010)

Nichols Institute Chemiluminescence AntiTG Assay (43075)

elias usa Synelisa TG Abs/TPO Abs EIA Kit

(16032)

elias usa elias TGAb EIA Kit (16034)

ANALYTE: Anti-Thyroid Microsomal

Antibodies (AMA) (0455)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Cogent Diagnostics AUTOSTAT

Autoantibody Test Kit (10207)

INOVA Diagnostics QUANTA Lite Thyroid

M ELISA (28272)

Immunoprobe Microsomal EIA Test Kit

(28349)

Joldon Diagnostics TMA Auto-Antibody

EIA Kit (31009)

Polymedco LUMItest anti-TPO (computer

calculations) (49109)

Polymedco LUMItest anti-TPO (manual

calculations) (49110)
Federal Register / Vol. 60, No. 93 / Monday, May 15, 1995 / Notices 25971

elias usa elias TMAb EIA Kit (16035)

ANALYTE: Anti-Trypanosoma cruzi

Antibodies (0503)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Abbott COMMANDER System (04334)

Abbott Chagas Antibody EIA (IgG) (04535)

Gull Laboratories Chagas IgG ELISA

(22173)

ANALYTE: Anti-U1-snRNP Antibodies

(0501)

TEST SYSTEM, ASSAY OR

EXAMINATION:

elias usa Synelisa ANA Profile (16058)

elias usa Synelisa ENA Screen (qualitative)

(16064)

elias usa Synelisa ENA Screen

(semiquantitative) (16065)

elias usa Synelisa U1-snRNP Antibodies

EIA Kit (16033)

ANALYTE: B1 positive Lymphocytes (0735)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Coulter Clone Immunophenotyping by

Fluorescence Microscopy (10253)

Coulter Epics Flow Cytometer (10246)

ANALYTE: B4 positive Lymphocytes (0736)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Coulter Clone Immunophenotyping by

Fluorescence Microscopy (10253)

Coulter Epics Flow Cytometer (10246)

ANALYTE: Beta-2 microglobulin (0703)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Coulter Beta-2 Microglobulin EIA (10205)

T Cell Diagnostics CELLFREE Beta-2 M

Test Kit (61120)

Wallac Oy DELFIA B–2 Micro Kit (70158)

ANALYTE: Blastomyces Antibodies (0724)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Meridian Diagnostics Premier Blastomyces

EIA (40148)

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

TEST SYSTEM, ASSAY OR

EXAMINATION:

Hemagen C-Relative Protein Kit (25172)

ANALYTE: CD3 (IgG1) positive Lymphocytes

(1111)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Coulter Clone Immunophenotyping by

Fluorescence Microscopy (10253)

Coulter Epics Flow Cytometer (10246)

ANALYTE: CD3 (IgG1)/B4 positive

Lymphocytes (1112)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Coulter Epics Flow Cytometer (10246)

ANALYTE: CD3 (IgG1)/T4 positive

Lymphocytes (1113)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Coulter Epics Flow Cytometer (10246)

ANALYTE: CD3 (IgG1)/T8 positive

Lymphocytes (1114)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Coulter Epics Flow Cytometer (10246)

ANALYTE: CD3 positive Lymphocytes (1110)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Becton Dickinson FACSCount System

(07601)

ANALYTE: CD3/HLA–DR positive

Lymphocytes (1115)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Becton Dickinson FACScan Flow

Cytometer (07497)

ANALYTE: CD4 positive Lymphocytes (1116)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Coulter CD4 Cytospheres Kit (10248)

ANALYTE: CD4/CD3 positive Lymphocytes

(1117)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Becton Dickinson FACSCount System

(07601)

ANALYTE: CD8 positive Lymphocytes (1118)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Coulter CD8 Cyto-Spheres Kit (10270)

ANALYTE: CD8/CD3 positive Lymphocytes

(1119)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Becton Dickinson FACSCount System

(07601)

ANALYTE: Coxiella burnetti (Q Fever)

Antibodies (1067)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Hillcrest Biologicals Q Fever (IgG) IFA Test

(25131)

Hillcrest Biologicals Q Fever (IgM) IFA

Test (25130)

ANALYTE: Cytomegalovirus Antibodies

(1039)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Abbott CMV–M EIA (04524)

Baxter Bartels Cytomegalovirus IgG PRIMA

System EIA (07502)

Baxter Bartels Cytomegalovirus IgM

PRIMA System EIA (07501)

DAKO IDEIA CMV–M (13339)

DAKO IDEIA CMV–M (13338)

Zeus CMV ELISA (simultaneous IgM & IgG)

Test System (79040)

ANALYTE: Epstein-Barr virus Antibodies

(1603)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Baxter Bartels Epstein-Barr Virus IgG

PRIMA System EIA (07504)

Baxter Bartels Epstein-Barr Virus IgM

PRIMA System EIA (07503)

Fuller Laboratories EBV–EA IgG AB IFA

Kit (19017)

Fuller Laboratories EBV–EBNA IFA Kit

(19018)

Fuller Laboratories EBV–VCA IgG Ab IFA

Kit (19016)

Incstar Clin–ELISA EBV EA(D) IgG (28266)

MRL Diagnostics Epstein-Barr Virus rVCA

IgM (40194)

Ortho Epstein-Barr Virus EA(D∂R)-IgG

Antibody ELISA Test (46146)

Ortho Epstein-Barr Virus EBNA-IgG

Antibody ELISA Test (46142)

Virion EBV Combi Test (67085)

Zeus EBV–VCA IgG Elisa (79039)

ANALYTE: Helicobacter pylori Antibodies

(2513)

TEST SYSTEM, ASSAY OR

EXAMINATION:

DAKO Helicobacter pylori IgG Test Kit

(13342)

Meridian Premier H. pylori EIA

(spectrophotometric) (40199)

Meridian Premier H. pylori EIA (visual)

(40198)

United Biotech UBI MAGIWEL H. pylori

IgG Test (64025)

ANALYTE: Herpes simplex I and/or II

Antibodies (2530)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Baxter Bartels Herpes simplex-1 Virus IgG

PRIMA System EIA (07506)

Baxter Bartels Herpes simplex-1 Virus IgM

PRIMA System EIA (07505)

Baxter Bartels Herpes simplex-2 Virus IgG

PRIMA System EIA (07508)

Baxter Bartels Herpes simplex-2 Virus IgM

PRIMA System EIA (07507)

ANALYTE: Immunoglobulins—monoclonal/

polyclonal (2802)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Helena Laboratories REP ImmunoFix

(25133)

Helena Laboratories Titan Gel Immunofix9 Procedure (25149)

The Binding Site IFE and Zone

Electrophoresis Kit (61117)

The Binding Site Immunofixation (IFE) Kit

(61115)

ANALYTE: Immunoglobulins IgA (2803)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Crestat Diagnostics N-Assay TIA IgA

(manual procedure) (10258)

ANALYTE: Immunoglobulins IgA subclasses

(2827)

TEST SYSTEM, ASSAY OR

EXAMINATION:

The Binding Site Human IgA Subclasses

NL RID Kit (61111)

ANALYTE: Immunoglobulins IgE (2805)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Abbott IgE EIA (04472)

Diagnostics Products Corp. AlaTOP

Microplate Allergy Screen (13293)

Hycor HY–TEC Total IgE EIA (25161)

MAST CLA Allergy System (densitometer)

(40176)

MAST CLA–1 Chemiluminescent Allergy

System (40177)

Roche Cobas Core IgE Total EIA (manual

procedure) (55120)

The Binding Site IgE EIA Test Kit (61105)

Wallac Oy DELFIA Total IgE Kit (70163)

ANALYTE: Immunoglobulins IgG (2806)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Crestat Diagnostics N-Assay TIA IgG

(manual procedure) (10256)

ANALYTE: Immunoglobulins IgG in tissue

samples (2830)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Ventana AEC Detection Kit (for tissue

sample) (67081)

Ventana DAB Detection Kit (for tissue

sample) (67083)
25972 Federal Register / Vol. 60, No. 93 / Monday, May 15, 1995 / Notices

Ventana Red, Alk.Phos. Fast Red Detect.

Kit (tissue sample) (67082)

ANALYTE: Immunoglobulins IgG subclasses

(2807)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Research Diagnostics Human IgG Subclass

RID Combi Kit (55151)

Research Diagnostics IgG Subclass ELISA

Combi Kit (55138)

ANALYTE: Immunoglobulins IgM (2808)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Crestat Diagnostics N-Assay TIA IgM

(manual procedure) (10259)

ANALYTE: Immunoglobulins IgM in tissue

samples (2831)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Ventana AEC Detection Kit (for tissue

sample) (67081)

Ventana DAB Detection Kit (for tissue

sample) (67083)

Ventana Red, Alk.Phos. Fast Red Detect.

Kit (tissue sample) (67082)

ANALYTE: Interleukin-2 Receptor (IL–2R)

(2821)

TEST SYSTEM, ASSAY OR

EXAMINATION:

T Cell Diagnostics CELLFREE Interleukin2 Receptor Kit (61119)

ANALYTE: Lyme Disease Antibodies

(Borrelia burgdorferi Abs) (3714)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Baxter Bartels B. burgdorferi (Lyme) IgM

PRIMA System EIA (07509)

ANALYTE: MY4 positive Lymphocytes

(4033)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Coulter Clone Immunophenotyping by

Fluorescence Microscopy (10253)

Coulter Epics Flow Cytometer (10246)

ANALYTE: Mo2 positive Lymphocytes

(4034)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Coulter Clone Immunophenotyping by

Fluorescence Microscopy (10253)

Coulter Epics Flow Cytometer (10246)

ANALYTE: Mumps Antibodies (4007)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Bion Mumps-G Antibody Test System

(07480)

ANALYTE: Mycoplasma pneumoniae

Antibodies (4016)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Fuller Laboratories Mycoplasma

pneumoniae IgG Antibody Kit (19021)

Shared Systems M. pneumoniae Antibody

EIA Test System (58287)

ANALYTE: Rheumatoid Factor (RF) (5508)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Clark Laboratories Encore Rheumatoid

Factor (RF) EIA Test (10242)

Immco Diagnostics ImmuLisa Rheumatoid

Factor ELISA (28352)

Sigma Diagnostics Rheumatoid Factor IgM

Kit (58333)

TheraTest Laboratories EL–RF–IgM Kit

(61134)

ANALYTE: Rubella Antibodies (5510)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Baxter Bartels Rubella Virus IgG PRIMA

System EIA (07513)

Baxter Bartels Rubella Virus IgM PRIMA

System EIA (07512)

DAKO IDEIA Rubella-G (13343)

DAKO IDEIA Rubella-M (13344)

ANALYTE: Rubeola Antibodies (measles)

(5511)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Baxter Bartels Rubeola Virus IgG PRIMA

System EIA (07511)

Baxter Bartels Rubeola Virus IgM PRIMA

System EIA (07510)

ANALYTE: T1 positive Lymphocytes (6145)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Coulter Clone Immunophenotyping by

Fluorescence Microscopy (10253)

Coulter Epics Flow Cytometer (10246)

ANALYTE: T11 positive Lymphocytes (6146)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Coulter Clone Immunophenotyping by

Fluorescence Microscopy (10253)

ANALYTE: T11/B1 positive Lymphocytes

(6147)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Coulter Epics Flow Cytometer (10246)

ANALYTE: T11/B4 positive Lymphocytes

(6148)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Coulter Epics Flow Cytometer (10246)

ANALYTE: T3 positive Lymphocytes (6149)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Coulter Clone Immunophenotyping by

Fluorescence Microscopy (10253)

Coulter Epics Flow Cytometer (10246)

ANALYTE: T4 positive Lymphocytes (6150)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Coulter Clone Immunophenotyping by

Fluorescence Microscopy (10253)

Coulter Epics Flow Cytometer (10246)

ANALYTE: T4/T8 positive Lymphocytes

(6151)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Coulter Epics Flow Cytometer (10246)

ANALYTE: T8 positive Lymphocytes (6152)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Coulter Clone Immunophenotyping by

Fluorescence Microscopy (10253)

Coulter Epics Flow Cytometer (10246)

ANALYTE: Thyroid Peroxidase

Autoantibodies (TPO) (6135)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Nichols Institute Chemiluminescence AntiTPO Assay (43076)

elias usa Synelisa TG Abs/TPO Abs EIA Kit

(16032)

ANALYTE: Toxoplasma gondii Antibodies

(6113)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Baxter Bartels Toxo IgG PRIMA System

EIA (07515)

Baxter Bartels Toxo IgG PRIMA System

EIA (07514)

DAKO IDEIA Toxo–G (13340)

DAKO IDEIA Toxo–M (13341)

Zeus Toxo IgM Test System (79041)

SPECIALITY/SUBSPECIALITY: Hematology

ANALYTE: Activated Partial Thromboplastin

Time (APTT) (0409)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Helena Laboratories APTT–ES (manual)

(25158)

MeDiTech APTT–ES (manual) (40192)

Vitek HEMOLAB Silimat (manual) (67089)

ANALYTE: Activated Plasma Clotting Time

(APCT) (0499)

TEST SYSTEM, ASSAY OR

EXAMINATION:

All Manual Tilt-Tube Coagulation

Procedures (04424)

ANALYTE: Alpha-2-Antiplasmin (0463)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Medical Laboratory MLA Electra 1600C

(40167)

ANALYTE: Antithrombin III (ATIII) (0456)

TEST SYSTEM, ASSAY OR

EXAMINATION:

American Bioproducts STA Analyzer

(04594)

Baxter Antithrombin III Chromogenic

Assay (07535)

Dade Thrombin-Antithrombin (TAT)

Complex ELISA (13292)

Kabi Pharmacia COATEST Antithrombin

(manual) (34061)

Medical Laboratory MLA Electra 1600C

(40167)

Organon Teknika Multi Channel Discrete

Analyzer (MDA–180) (46144)

Sigma ACCUCOLOR Antithrombin III

(58320)

Vitek HEMOLAB (67075)

ANALYTE: Coagulation Factors (1044)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Diagnostica Stago Deficient II Factor Assay

(manual) (13297)

Diagnostica Stago Deficient V Factor Assay

(manual) (13296)

Diagnostica Stago Deficient VII Factor

Assay (manual) (13305)

Diagnostica Stago Deficient X Factor Assay

(manual) (13306)

Diagnostica Stago Deficient XI Factor

Assay (manual) (13307)

Diagnostica Stago Deficient XII Factor

Assay (manual) (13304)

Helena Laboratories Cascade M (25156)

Instrumentation Laboratory MCL 2

Coagulation Analyzer (28297)

International Technidyne Factor VI (28093)

International Technidyne Factor VI

Premier (28296)

International Technidyne Hemochron 400

(28094)

International Technidyne Hemochron 401

(28095)

International Technidyne Hemochron 800

(28096)
Federal Register / Vol. 60, No. 93 / Monday, May 15, 1995 / Notices 25973

International Technidyne Hemochron 8000

(28298)

International Technidyne Hemochron 801

(28097)

MeDiTech Chromogenic Factor VIII:C

Assay Kit (40180)

Medical Laboratory MLA Electra 1600C

(40167)

Organon Teknika Multi Channel Discrete

Analyzer (MDA–180) (46144)

TOA Medical Electronics CA–1000 (61132)

TOA Medical Electronics CA–5000 (61135)

Vitek HEMOLAB (67075)

ANALYTE: Fibrin Monomers (1927)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Protamine Sulfate (with serial dilutions)

(49106)

ANALYTE: Fibrinogen (1905)

TEST SYSTEM, ASSAY OR

EXAMINATION:

All Manual Tilt-Tube Coagulation

Procedures (04424)

Behring Multifibren U (manual) (07545)

Behring Multifibrin (manual) (07517)

Diagnostic Specialties EnZIP

Immunoturbidometric (manual) (13319)

Helena Laboratories Fibrinogen Assay Kit

(manual) (25152)

The Binding Site Human Fibrinogen RID

(61101)

ANALYTE: Hematocrit (2514)

TEST SYSTEM, ASSAY OR

EXAMINATION:

DMA H10 (13283)

DMA H3–HCT (13277)

DMA H5 (13280)

DMA H5–M (13279)

DMA H7 (13281)

Mallinckrodt H5–M (40171)

Mallinckrodt S–610 (40169)

Mallinckrodt S–650 (40172)

Mallinckrodt S–670 (40173)

SmithKline ESKALAB–CHS H10 (58305)

SmithKline ESKALAB–CHS H3–HCT

(58300)

SmithKline ESKALAB–CHS H5 (58303)

SmithKline ESKALAB–CHS H5–M (58302)

SmithKline ESKALAB–CHS H7 (58304)

Texas International Laboratories H10

(61127)

Texas International Laboratories H3–HCT

(61121)

Texas International Laboratories H5

(61124)

Texas International Laboratories H5–M

(61123)

Texas International Laboratories H7

(61125)

ANALYTE: Hemoglobin (2515)

TEST SYSTEM, ASSAY OR

EXAMINATION:

DMA H10 (13283)

DMA H3–Hgb (13278)

DMA H5 (13280)

DMA H5–M (13279)

DMA H7 (13281)

Mallinckrodt H5–M (40171)

Mallinckrodt S–630 (40170)

Mallinckrodt S–650 (40172)

Mallinckrodt S–670 (40173)

SmithKline ESKALAB–CHS H10 (58305)

SmithKline ESKALAB–CHS H3–Hgb

(58301)

SmithKline ESKALAB–CHS H5 (58303)

SmithKline ESKALAB–CHS H5–M (58302)

SmithKline ESKALAB–CHS H7 (58304)

Texas International Laboratories H10

(61127)

Texas International Laboratories H3–Hgb

(61122)

Texas International Laboratories H5

(61124)

Texas International Laboratories H5–M

(61123)

Texas International Laboratories H7

(61125)

ANALYTE: Heparin (2518)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Behring Berichrome Heparin (07481)

Biopool Spectrolyse Heparin (07526)

Vitek HEMOLAB (67075)

Vitek HEMOLAB Heparichrom (67095)

ANALYTE: Heparin, Low Molecular Weight

(LMWH) (2558)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Instrumentation Laboratory IL Test

Heparin (Xa) (28341)

ANALYTE: Heparin/Protamine Titration

(HPT) (2538)

TEST SYSTEM, ASSAY OR

EXAMINATION:

International Technidyne Factor VI (28093)

International Technidyne Hemochron 400

(28094)

International Technidyne Hemochron 401

(28095)

International Technidyne Hemochron 800

(28096)

International Technidyne Hemochron 801

(28097)

ANALYTE: Lupus Anticoagulants (3728)

TEST SYSTEM, ASSAY OR

EXAMINATION:

American Diagnostica DVVtest

&DVVconfirm (manual) (04543)

Biopool Bioclot LA (manual procedure)

(07522)

Diagnostica Stago STACLOT LA (13285)

Diagnostica Stago STACLOT PNP (13273)

Gradipore Lupo-Test II & Lucor (22163)

ANALYTE: Plasminogen (4907)

TEST SYSTEM, ASSAY OR

EXAMINATION:

American Bioproducts STA Analyzer

(04594)

Medical Laboratory MLA Electra 1600C

(40167)

The Binding Site Plasminogen RID Test Kit

(61159)

ANALYTE: Plasminogen Activator Inhibitor

(PAI) (4936)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Baxter Plasminogen Activator Inhibitor-1

(PAI) (07521)

Biopool Spectrolyse/pL PAI (07482)

ANALYTE: Platelet Count (4908)

TEST SYSTEM, ASSAY OR

EXAMINATION:

DMA H10 (13283)

DMA Plt–4 (13282)

Mallinckrodt Plt–4 (40174)

SmithKline ESKALAB–CHS H10 (58305)

SmithKline ESKALAB–CHS Plt–4 (58306)

Texas International Laboratories H10

(61127)

Texas International Laboratories Plt–4

(61126)

ANALYTE: Protamine Response Test (PRT)

(4945)

TEST SYSTEM, ASSAY OR

EXAMINATION:

International Technidyne Hemochron 8000

(28298)

ANALYTE: Protein C (4929)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Behring Fibrintimer A (07516)

Boehringer Mannheim Hitachi 704 (07161)

Boehringer Mannheim Hitachi 705 (07162)

Boehringer Mannheim Hitachi 717 (07163)

Chromogenix COAMATE Protein C

(manual procedure) (10252)

Medical Laboratory MLA Electra 1600C

(40167)

Organon Teknika Multi Channel Discrete

Analyzer (MDA–180) (46144)

Roche Cobas Bio (55100)

Roche Cobas FARA (55040)

Roche Cobas Mira (55044)

The Binding Site Human Protein C RID

Test Kit (61180)

Vitek HEMOLAB (67075)

Vitek HEMOLAB Protein C chrom (manual

procedure) (67086)

ANALYTE: Protein S (4930)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Instrumentation Laboratory IL ACL 100

(28073)

Instrumentation Laboratory IL ACL 1000

(28074)

Instrumentation Laboratory IL ACL 200

(28075)

Instrumentation Laboratory IL ACL 2000

(28076)

Instrumentation Laboratory IL ACL 300

(28077)

Instrumentation Laboratory IL ACL 300

Plus (28197)

Instrumentation Laboratory IL ACL 3000

(28078)

Instrumentation Laboratory IL ACL 3000

Plus (28079)

Instrumentation Laboratory IL ACL 810

(28080)

ANALYTE: Prothrombin Time (PT) (4922)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Helena Laboratories Thromboplastin

Reagent-MI (manual) (25163)

ANALYTE: Red Blood Cell Count

(Erythrocyte Count) (RBC) (5502)

TEST SYSTEM, ASSAY OR

EXAMINATION:

DMA H10 (13283)

DMA H3–HCT (13277)

DMA H3–Hgb (13278)

DMA H5 (13280)

DMA H5–M (13279)

DMA H7 (13281)

Mallinckrodt H5–M (40171)

Mallinckrodt S–610 (40169)

Mallinckrodt S–630 (40170)

Mallinckrodt S–650 (40172)

Mallinckrodt S–670 (40173)

SmithKline ESKALAB–CHS H10 (58305)

SmithKline ESKALAB–CHS H3–HCT

(58300)

SmithKline ESKALAB–CHS H3–Hgb

(58301)
25974 Federal Register / Vol. 60, No. 93 / Monday, May 15, 1995 / Notices

SmithKline ESKALAB–CHS H5 (58303)

SmithKline ESKALAB–CHS H5–M (58302)

SmithKline ESKALAB–CHS H7 (58304)

Texas International Laboratories H10

(61127)

Texas International Laboratories H3–HCT

(61121)

Texas International Laboratories H3–Hgb

(61122)

Texas International Laboratories H5

(61124)

Texas International Laboratories H5–M

(61123)

Texas International Laboratories H7

(61125)

ANALYTE: Reptilase Time (5521)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Behring Batroxobin (manual procedure)

(07534)

ANALYTE: Reticulocyte Count (5506)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Becton Dickinson FACScan Flow

Cytometer (07497)

ANALYTE: Semen (5822)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Serono Penetrak (58352)

ANALYTE: Thrombin Time (6105)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Behring Test Thrombin (manual) (07495)

Vitek HEMOLAB Thrombicalci-Test

(manual) (67090)

ANALYTE: Thrombin/antithrombin III

Complex (TAT) (6136)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Behring Enzygnost TAT (07483)

ANALYTE: Tissue Plasminogen Activator (tPA) (6130)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Biopool TintElize tPA (07525)

ANALYTE: White Blood Cell Count

(Leukocyte Count) (WBC) (7002)

TEST SYSTEM, ASSAY OR

EXAMINATION:

DMA H10 (13283)

DMA H3–HCT (13277)

DMA H3–Hgb (13278)

DMA H5 (13280)

DMA H5–M (13279)

DMA H7 (13281)

Mallinckrodt H5–M (40171)

Mallinckrodt S–610 (40169)

Mallinckrodt S–630 (40170)

Mallinckrodt S–650 (40172)

Mallinckrodt S–670 (40173)

SmithKline ESKALAB–CHS H10 (58305)

SmithKline ESKALAB–CHS H3–HCT

(58300)

SmithKline ESKALAB–CHS H3–Hgb

(58301)

SmithKline ESKALAB–CHS H5 (58303)

SmithKline ESKALAB–CHS H5–M (58302)

SmithKline ESKALAB–CHS H7 (58304)

Texas International Laboratories H10

(61127)

Texas International Laboratories H3–HCT

(61121)

Texas International Laboratories H3–Hgb

(61122)

Texas International Laboratories H5

(61124)

Texas International Laboratories H5–M

(61123)

Texas International Laboratories H7

(61125)

ANALYTE: von Willebrand Factor

(Ristocetin Cofactor) (6711)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Chrono-log Ristocetin Cofactor Assay

(10282)

SPECIALITY/SUBSPECIALITY: Mycology

ANALYTE: Yeast (7601)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Innovative Diag. Systems RapID Yeast Plus

System (inc. cult) (28383)

ANALYTE: Yeast, Cryptocococcus only

(7604)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Trinity Laboratories CRYPTO–LEX System

(61136)

SPECIALITY/SUBSPECIALITY: Parasitology

ANALYTE: Cryptosporidium (1109)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Alexon ProSpecT Cryptosporidium

Microtiter (dir Ag/spectro) (04326)

Alexon ProSpecT Cryptosporidium

Microtiter (dir Ag/visual) (04325)

LMD Laboratories Cryptosporidium Ag

Detect. Microtiter(vis) (37018)

Meridian Diagnostics MERIFLUOR

Cryptosporidium (40100)

Meridian Diagnostics MERIFLUOR

Cryptosporidium/Giardia (40095)

Seradyn Color Vue—Cryptosporidium (dir.

Ag/spectrophoto) (58184)

Seradyn Color Vue—Cryptosporidium

(direct, Ag/visual) (58297)

ANALYTE: Entamoeba histolytica (1631)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Alexon ProSpecT Entamoeba histolytica

(direct Ag/spectro) (04530)

Alexon ProSpecT Entamoeba histolytica

(direct Ag/visual) (04529)

ANALYTE: Giardia lamblia (2222)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Alexon ProSpecT Giardia EZ Microplate

Assay (dir Ag/spectr) (04585)

Alexon ProSpecT Giardia EZ Microplate

Assay (dir Ag/visual) (04586)

Alexon ProSpecT Giardia Microplate Assay

(dir Ag/spectro) (04557)

Alexon ProSpecT Giardia Microplate Assay

(dir Ag/visual) (04558)

Alexon ProSpecT Giardia Microtiter (dir

Ag/spectrophoto) (04257)

Alexon ProSpecT Giardia Microtiter (dir

antigen/visual) (04099)

Alexon ProSpecT/Giardia (tube) (dir Ag/

visual) (04338)

Antibodies Inc. Giard EIA (direct antigen/

visual) (04224)

LMD Laboratories G. lamblia Ag Detect.

Microtiter (spectro) (37032)

LMD Laboratories G. lamblia Ag Detect.

Microtiter (visual) (37019)

Meridian Diagnostics MERIFLUOR

Cryptosporidium/Giardia (40095)

Meridian Diagnostics MERIFLUOR Giardia

(40099)

Seradyn Color Vue—Giardia (dir Ag/

spectrophoto) (58183)

Seradyn Color Vue—Giardia (direct Ag/

visual) (58296)

Trend Scientific Giardia lamblia Direct

Detection System (61019)

ANALYTE: Pneumocystis (4926)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Polysciences Fungi-Fluor Pneumocystis

(49099)

SPECIALITY/SUBSPECIALITY: Toxicology/

TDM

ANALYTE: Amphetamines (0428)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Microdiagnostics MICRO EIA (40191)

STC Diagnostics Amphetamines EIA Plate

Kit (58299)

USDT Flow Immunoassay System (64026)

ANALYTE: Cannabinoids (THC) (1009)

TEST SYSTEM, ASSAY OR

EXAMINATION:

STC Diagnostics Cannabinoids EIA Plate

Kit (58292)

USDT Flow Immunoassay System (64026)

ANALYTE: Cocaine Metabolites (1023)

TEST SYSTEM, ASSAY OR

EXAMINATION:

USDT Flow Immunoassay System (64026)

ANALYTE: Digoxin (1304)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Diatron FAST Test System (13287)

Wallac Oy DELFIA Digoxin Kit (70160)

ANALYTE: Morphine (4020)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Immunalysis Urine Morphine Direct RIA

Kit (28342)

ANALYTE: Opioates (4601)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Microdiagnostics Micro EIA Opiate

Metabolites (40168)

STC Diagnostics Opiates EIA Plate Kit

(58298)

USDT Flow Immunoassay System (64026)

ANALYTE: Phencyclidine (PCP) (4901)

TEST SYSTEM, ASSAY OR

EXAMINATION:

USDT Flow Immunoassay System (64026)

SPECIALITY/SUBSPECIALITY: Virology

ANALYTE: Adenovirus (0410)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Baxter Bartels Viral Respiratory Kit

(including cell cult) (07359)

Light Diag. Respir. Panel 1 Screen & ID Kit

(inc. cell cult) (37068)

ANALYTE: Cytomegalovirus (1038)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Diagnostic Products PathoDx

Cytomegalovirus (inc. cell cult) (13298)

Light Diag. Cytomegalovirus Indirect

Immunofluorescence Kit (37089)

NeoGenex CMV Early Antigen Test

(including cell culture) (43092)

ANALYTE: Herpes simplex (2529)

TEST SYSTEM, ASSAY OR

EXAMINATION:
Federal Register / Vol. 60, No. 93 / Monday, May 15, 1995 / Notices 25975

DAKO IDEIA Herpes simplex (direct Ag)

(13332)

DAKO IMAGEN Herpes simplex (inc. cell

culture) (13333)

ANALYTE: Human Papillomavirus (HPV)

(2540)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Digene ViraType Plus HPV DNA Assay

(13323)

ANALYTE: Influenza A (2828)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Analytab API IMAGEN Influenza Virus

A&B (direct antigen) (04215)

Analytab API IMAGEN Influenza Virus

A&B (inc.cell culture) (04512)

Baxter Bartels PRIMA Influenza A EIA

(direct Ag/spectro) (07490)

Baxter Bartels PRIMA Influenza A EIA (inc.

cell culture) (07492)

Baxter Bartels Viral Respiratory Kit (direct

antigen) (07035)

Baxter Bartels Viral Respiratory Kit

(including cell cult) (07359)

DAKO IMAGEN Influenza (direct antigen)

(13336)

DAKO IMAGEN Influenza (including cell

culture) (13337)

Gull Laboratories Influenza A Test

(including cell culture) (22106)

Light Diag. Respir. Panel 1 Screen & ID Kit

(inc.cell cult) (37068)

NeoGenex Influenza A Antigen Test

(including cell culture) (40393)

ANALYTE: Influenza B (2829)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Analytab API IMAGEN Influenza Virus

A&B (direct antigen) (04215)

Analytab API IMAGEN Influenza Virus

A&B (inc. cell culture) (04512)

Baxter Bartels Viral Respiratory Kit (direct

antigen) (07035)

Baxter Bartels Viral Respiratory Kit

(including cell cult) (07359)

DAKO Diagnostics IMAGEN Influenza

(direct antigen) (13336)

DAKO Diagnostics IMAGEN Influenza

(including cell culture) (13337)

Gull Laboratories Influenza B Test

(including cell culture) (22107)

Light Diag. Respir. Panel 1 Screen & ID Kit

(inc. cell cult) (37068)

NeoGenex Influenza B Antigen Test

(including cell culture) (43096)

ANALYTE: Parainfluenza 1 (4959)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Baxter Bartels Viral Respiratory Kit (direct

antigen) (07035)

Baxter Bartels Viral Respiratory Kit

(including cell cult) (07359)

DAKO IMAGEN Parainfluenza virus Group

(inc. cell culture) (13373)

DAKO IMAGEN Parainfluenza virus Types

1, 2, 3 (inc. cell cult) (13374)

Light Diag. Respir. Panel 1 Screen & ID Kit

(inc.cell cult) (37068)

Symex ViraSTAT Anti-Parainfluenza

MAbs (58315)

ANALYTE: Parainfluenza 2 (4960)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Baxter Bartels Viral Respiratory Kit

(including cell cult) (07359)

DAKO IMAGEN Parainfluenza virus Group

(inc. cell culture) (13373)

DAKO IMAGEN Parainfluenza virus Types

1,2,3 (inc. cell cult) (13374)

Light Diag. Respir. Panel 1 Screen & ID Kit

(inc. cell cult) (37068)

Symex ViraSTAT Anti-Parainfluenza

MAbs (58315)

ANALYTE: Parainfluenza 3 (4961)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Baxter Bartels Viral Respiratory Kit (direct

antigen) (07035)

Baxter Bartels Viral Respiratory Kit

(including cell cult) (07359)

DAKO IMAGEN Parainfluenza virus Group

(inc. cell culture) (13373)

DAKO IMAGEN Parainfluenza virus Types

1,2,3 (inc. cell cult) (13374)

Light Diag. Respir. Panel 1 Screen & ID Kit

(inc. cell cult) (37068)

Symex ViraSTAT Anti-Parainfluenza

MAbs (58315)

ANALYTE: Respiratory syncytial virus (5503)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Baxter Bartels Viral Respiratory Kit (direct

antigen) (07035)

Baxter Bartels Viral Respiratory Kit

(including cell cult) (07359)

DAKO IMAGEN RSV (direct antigen)

(13335)

Diagnostic Products Corp. PathoDx RSV

Kit (direct antigen) (13324)

Diagnostic Products Corp. PathoDx RSV

Kit (inc. cell cult.) (13325)

Light Diag. Respir. Panel 1 Screen & ID Kit

(inc. cell cult) (37068)

NeoGenex RSV Antigen Test (including

cell culture) (43094)

Sanofi/Kallestad RSV Microplate EIA

(direct Ag/spectro) (58286)

ANALYTE: Rotavirus (5509)

TEST SYSTEM, ASSAY OR

EXAMINATION:

DAKO ELISA Rotavirus Kit (direct Ag/

spectrophoto) (13331)

DAKO ELISA Rotavirus Kit (direct Ag/

visual) (13330)

DAKO IDEIA Rotavirus (direct antigen/

spectro) (13295)

DAKO IDEIA Rotavirus (direct antigen/

visual) (13294)

ANALYTE: Varicella-Zoster viruses (6705)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Viro Varicella-Zoster Virus ID Reagent

(direct antigen) (67093)

Viro Varicella-Zoster Virus ID Reagent (inc.

cell culture) (67094)

COMPLEXITY: WAIVED

SPECIALITY/SUBSPECIALITY:

Endocrinology

ANALYTE: Ovulation Test (LH) by Visual

Color Comparison (9461)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Applied Biotech Ovugen 1-Step Ovulation

Prediction Test (04514)

BioGenex OvuGen 1-Step Ovulation

Prediction Test (07477)

Disease Detection Internat. Pro-Step LH

Ovulation Pred. Tst (13316)

Princeton BioMeditech OvuSign One-Step

Ovulation Prediction (49093)

TCPI One Step LH Test (61158)

ANALYTE: Urine HCG by Visual Color

Comparison Tests (9642)

TEST SYSTEM, ASSAY OR

EXAMINATION:

ANI BIOCARD HCG (04549)

ANI BIOTECH OY BIOCARD HCG (04502)

Abbott TestPack HCG-combo (04074)

Advanced Care Products 1 Easy Step

ADVANCE Pregnancy Test (04591)

Apotex ProPhase Plus (04534)

Apotex ProStrip HCG (04533)

Apothecus VCF One Step Pregnancy Test

(04606)

Applied Biotech SureStep Combo hCG

(04528)

Applied Biotech SureStep HCG Pregnancy

Test (04441)

Applied Biotech SureStick HCG Pregnancy

Test (04522)

Becton Dickinson Precise One-step

Pregnancy Test (07476)

BioTech Atlantic UniStep HCG Pregnancy

Test Device (07544)

BioTech Atlantic UniStep HCG Pregnancy

Test Strips (07543)

Biomed Diagnostics ProClinic One-Step

DipStick Pregnancy (07478)

Boehringer Mannheim BMIt EVATEST

Test Strip (07550)

Boehringer Mannheim EVENT test strip

hCG (07533)

Disease Detection International Pro-Step

PT hCG (13271)

Disease Detection International Pro-Step

hCG (13270)

Eucardio Laboratories UC QIK 1-Step HCG

Test (16072)

Eucardio Laboratory UC Qik Pregnancy

Test (16029)

King’s Bay Prelude hCG Combo Kit (34062)

Mainline Technology MAINLINE Confirms

hCG (40190)

Medix Biotech BESTest hCG Urine (40166)

Mizuho USA HCG Midstream (40178)

Organon Teknika Predictor Pregnancy Test

(46151)

Pacific Biotech Concise Plus HCG-Urine

(49123)

Princeton BioMeditech BioStrip hCG

(49131)

Princeton BioMeditech LifeSign 1 OneStep Home Preg. Test (49127)

Princeton BioMeditech LifeSign Plus One

Step Home Pregnancy (49095)

Quidel Conceive 1-Step Pregnancy Test

(52021)

Quidel QuickVue One-Step hCG Combo

Test (52022)

Quidel QuickVue One-Step hCG Test

(52018)

Quidel RapidVue hCG (52025)

SA Scientific Pregnancy Check (58328)

SA Scientific SAS One-Step Pregnancy

(58282)

SA Scientific SAS Pregnancy Strip (58284)

SA Scientific SAS Serum/Urine hCG

(58283)

Stanbio QuPid Plus hCG Pregnancy Test

(58326)

Stanbio QuPid visual one-step pregnancy

test (58325)

Stanbio QuStick visual one-step pregnancy

test (58324)

Sun Biomedical Laboratories Visualine II

HCG (58341)
25976 Federal Register / Vol. 60, No. 93 / Monday, May 15, 1995 / Notices

Syntron Bioresearch Be Sure Plus One Step

Pregnancy Test (58285)

Syntron Bioresearch QuikPac II hCG

Combo Kit (58353)

TCPI PDQ (Pregnancy Detected Quickly)

Wand (61166)

TCPI hCG Pregnancy One Step Test Strip

(61100)

TCPI hCG Pregnancy One Step Wand

(61167)

TECH-CO Visual HCG Pregnancy Test

(61099)

TECO One-Step Pregnancy Test (61146)

The Mentholatum Co. BODYWISE

Pregnancy Test (61160)

True Medix Beta Spec hCG (61139)

Unipath Clearview HCG DUO (64031)

Unipath Clearview HCG Test (64024)

SPECIALITY/SUBSPECIALITY: General

Chemistry

ANALYTE: Fecal Occult Blood (9191)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Aerscher HemaPrompt (04544)

Propper Super Seracult (49096)

ANALYTE: Glucose Monitoring Devices

(FDA Cleared/Home Use) (9221)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Ames Glucometer ELITE Blood Glucose

Test Strips (04521)

Ames Glucometer ELITE Diabetes Care

System (04499)

Ames Glucometer ENCORE Blood Glucose

Test Strips (04501)

Ames Glucometer ENCORE QA Blood

Glucose Meter (04423)

Ames Glucometer ENCORE System (04500)

Ames Glucometer QA Blood Glucose Meter

(04422)

Boehringer Mannheim Accu-Chek

Advantage (07523)

Cascade Medical CheckMate Plus Blood

Glucose System (10236)

Clinical Diagnostics GLUCOchek Visual

Test Strips (10272)

Diagnostic Solutions Quick Check One Bld

Glucose Test Strips (13300)

Diagnostic Solutions Relief Plus Blood

Glucose Test Strips (13299)

HemoCue B-Glucose System (25112)

Home Diagnostics ULTRA+ Blood Glucose

Reagent Strips (25154)

Lifescan ONE TOUCH IIB Blood Glucose

Meter (37067)

Polymer Technology ‘‘655’’ Glucose Test

Strips (49094)

SPECIALITY/SUBSPECIALITY: Hematology

ANALYTE: Spun Microhematocrit (9581)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Separation Technology STI HemataSTAT II

(58311)

Separation Technology STI HemataSTAT

Model C70 (58309)

SPECIALITY/SUBSPECIALITY: Urinalysis

ANALYTE: Urine Dipstick or Tablet

Analytes, nonautomated (9641)

TEST SYSTEM, ASSAY OR

EXAMINATION:

Bio-Scan Bio-Gen 2 (07456)

Bio-Scan Bio-Gen 3 (07455)

Bio-Scan Bio-Gen 4 (07454)

Bio-Scan Bio-Gen 5 (07453)

Bio-Scan Bio-Gen 6 (07452)

Bio-Scan Bio-Gen 7 (07451)

Bio-Scan Bio-Gen 8 (07450)

Bio-Scan Bio-Glu Ketone (07457)

Bio-Scan Bio-Glucose (07459)

Bio-Scan Bio-Ketone (07458)

BioScan Reagent Strips (07541)

Boehringer Mannheim Chemstrip 10 S–UA

(07519)

Eiken UROPAPER Eiken 5 (16049)

Eiken UROPAPER Eiken 6B (16059)

Eiken UROPAPER Eiken 7 (16053)

Eiken UROPAPER Eiken 8 (16052)

Eiken UROPAPER Eiken AG (16050)

Eiken UROPAPER Eiken GK(16068)

Eiken UROPAPER Eiken GP (16069)

Eiken UROPAPER Eiken HAG (16051)

Eli Lilly Tes-Tape (Glucose Enzymatic Test

Strip) (16030)

TECO Diagnostics Urine Reagent Strips 3

(61153)

[FR Doc. 95–11653 Filed 5–12–95; 8:45 am]

BILLING CODE 4160–17–M