25796 Federal Register / Vol. 65, No. 86 / Wednesday, May 3, 2000 / Notices

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Centers for Disease Control and

Prevention

Notice of Specific List for

Categorization of Laboratory Test

Systems, Assays, and Examinations

by Complexity

AGENCY: Centers for Disease Control and

Prevention (CDC), Department of Health

and Human Services (HHS).

ACTION: Notice with comment period.

SUMMARY: Regulations at 42 CFR 493.15

and 493.17, implementing the Clinical

Laboratory Improvement Amendments

of 1988 (CLIA), Public Law 100–578

(codified at 42 U.S.C. 263a), require that

the Secretary provide for the

categorization of specific laboratory test

systems, assays, and examinations by

level of complexity. The criteria for

such categorizations also are set forth in

those regulations.

This Notice announces the addition

of: approximately 1,130 test systems,

assays, and examinations categorized by

CDC as moderate or high complexity

with categorization notification to

manufacturers between September 4,

1999 and January 31, 2000; and 46 test

systems, assays, and examinations CDC

determined as waived with notification

to manufacturers between September 4,

1999 and February 28, 2000. HHS

invites comments on the tests initially

categorized in this Notice and reserves

the right to reevaluate and recategorize

tests based on the comments received in

response to this Notice.

DATES: Effective date: All

categorizations in this Notice were

effective on the date of the test

categorization notification letter sent to

the manufacturer. Written comments on

the tests initially categorized in this

Notice will be considered if they are

received at the address indicated below,

by no later than 5 p.m. on June 2, 2000.

HHS reserves the right to reevaluate and

recategorize tests based on the

comments received in response to this

Notice.

ADDRESSES: Comments on the

categorization of tests in this Notice

should be addressed to CLIA Federal

Register Notice, Centers for Disease

Control and Prevention, Public Health

Practice Program Office, Mail Stop F–

11, 4770 Buford Highway, NE, Atlanta,

Georgia 30341–3724.

FOR FURTHER INFORMATION CONTACT:

Sharon Granade, (770) 488–8155.

SUPPLEMENTARY INFORMATION: CDC also

maintains an electronic list of

categorized tests which is available via

the Internet (http://

www.phppo.cdc.gov/dls/clia/

testcat.asp).

Comments and Responses

On September 23, 1999, a test list of

approximately 5,700 test systems,

assays, and examinations categorized by

level of complexity was published in

the Federal Register (64 FR 51590) with

a 30 day comment period. CDC received

no comment letters in regard to this

Notice.

Correction

Upon reevaluation, the complexity

categorization for the analyte Heparin

Dose Response (2539) was changed from

Moderate to High when performed using

the following test systems:

ITC Factor VI (28093);

ITC HEMOCHRON 400 (28094);

ITC HEMOCHRON 401 (28095);

ITC HEMOCHRON 800 (28096);

ITC HEMOCHRON 801 (28097).

These systems require manual

calculations and a manually plotted

graph to calculate the final

recommended heparin dose results.

Dated: April 26, 2000.

Joseph R. Carter,

Associate Director for Management and

Operations, Centers for Disease Control and

Prevention.

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: Clostridium difficile (1022)

TEST SYSTEM, ASSAY,

EXAMINATION:

BioStar CdTOX A OIA (08228)

ANALYTE: Gardnerella vaginalis (2212)

TEST SYSTEM, ASSAY,

EXAMINATION:

BioStar Acceava Gardnerella vaginalis

PIP Activity Test Card (from vaginal

swab) (08222)

ANALYTE: Streptococcus pneumoniae

(5808)

TEST SYSTEM, ASSAY,

EXAMINATION:

Binax NOW Streptococcus pneumoniae

Urinary Antigen Test (08220)

SPECIALITY/SUBSPECIALITY:

Endocrinology

ANALYTE: Collagen Type I Crosslink,

N-telopeptides (NTx) (1125)

TEST SYSTEM, ASSAY,

EXAMINATION:

Ostex International Osteomark NTx

Point of Care (POC) (46321)

ANALYTE: Cortisol (1032)

TEST SYSTEM, ASSAY,

EXAMINATION:

Bayer ADVIA IMS (08254)

TOSOH AIA–600 II (61464)

ANALYTE: Erythropoietin (1611)

TEST SYSTEM, ASSAY,

EXAMINATION:

Nichols Institute Advantage

Chemiluminescence System (43122)

ANALYTE: Estradiol (1605)

TEST SYSTEM, ASSAY,

EXAMINATION:

Bayer ADVIA IMS (08254)

TOSOH AIA–600 II (61464)

ANALYTE: Follicle Stimulating

Hormone (FSH) (1908)

TEST SYSTEM, ASSAY,

EXAMINATION:

Bayer ADVIA IMS (08254)

Behring OPUS Magnum (07794)

Behring OPUS Plus (07795)

TOSOH AIA–600 II (61464)

ANALYTE: HCG, Beta, Serum,

Quantitative (2502)

TEST SYSTEM, ASSAY,

EXAMINATION:

Bayer ADVIA IMS (08254)

Behring OPUS Magnum (07794)

Behring OPUS Plus (07795)

TOSOH AIA–600 II (61464)

ANALYTE: HCG, Intact, Serum,

Quantitative (2567)

TEST SYSTEM, ASSAY,

EXAMINATION:

TOSOH AIA–600 II (61464)

ANALYTE: HCG, Serum, Qualitative

(2501)

TEST SYSTEM, ASSAY,

EXAMINATION:

Fisher HealthCare Sure-Vue Serum/

Urine hCG (19041)

Fisher HealthCare Sure-Vue Serum/

Urine hCG-STAT (19040)

ANALYTE: HCG, Urine (2503)

TEST SYSTEM, ASSAY,

EXAMINATION:

Germaine Laboratories Aim Direct

Federal Register / Vol. 65, No. 86 / Wednesday, May 3, 2000 / Notices 25797

Pregnancy (22272)

ANALYTE: Human Growth Hormone

(GH) (2547)

TEST SYSTEM, ASSAY,

EXAMINATION:

TOSOH AIA–600 II (61464)

ANALYTE: Insulin (2812)

TEST SYSTEM, ASSAY,

EXAMINATION:

TOSOH AIA–600 II (61464)

ANALYTE: Luteinizing Hormone (LH)

(3713)

TEST SYSTEM, ASSAY,

EXAMINATION:

Bayer ADVIA IMS (08254)

Behring OPUS Magnum (07794)

Behring OPUS Plus (07795)

TOSOH AIA–600 II (61464)

ANALYTE: Parathyroid Hormone—

Intact (4924)

TEST SYSTEM, ASSAY,

EXAMINATION:

Roche Diagnostics Elecsys 1010

Analyzer (55361)

Roche Diagnostics Elecsys 2010

Analyzer (55362)

ANALYTE: Progesterone (4914)

TEST SYSTEM, ASSAY,

EXAMINATION:

Bayer ADVIA IMS (08254)

TOSOH AIA–600 II (61464)

ANALYTE: Prolactin (4915)

TEST SYSTEM, ASSAY,

EXAMINATION:

Bayer ADVIA IMS (08254)

Behring OPUS Magnum (07794)

Behring OPUS Plus (07795)

TOSOH AIA–600 II (61464)

ANALYTE: T Uptake (TU) (6156)

TEST SYSTEM, ASSAY,

EXAMINATION:

Bayer ADVIA IMS (08254)

TOSOH AIA–600 II (61464)

ANALYTE: Thyroid Stimulating

Hormone (TSH) (6106)

TEST SYSTEM, ASSAY,

EXAMINATION:

Behring OPUS Magnum (07794)

Behring OPUS Plus (07795)

TOSOH AIA–600 II (61464)

ANALYTE: Thyroid Stimulating

Hormone (TSH) Third Generation

(6155)

TEST SYSTEM, ASSAY,

EXAMINATION:

Bayer ADVIA IMS (08254)

TOSOH AIA–600 II (61464)

ANALYTE: Thyroxine (T4) (6109)

TEST SYSTEM, ASSAY,

EXAMINATION:

Bayer ADVIA IMS (08254)

Behring OPUS Magnum (07794)

Behring OPUS Plus (07795)

Roche Diagnostics Cobas INTEGRA

400 (55634)

Roche Diagnostics Cobas INTEGRA

700 (55643)

TOSOH AIA–600 II (61464)

ANALYTE: Thyroxine, Free (FT4)

(6111)

TEST SYSTEM, ASSAY,

EXAMINATION:

Bayer ADVIA IMS (08254)

TOSOH AIA–600 II (61464)

ANALYTE: Triiodothyronine (T3)

(6119)

TEST SYSTEM, ASSAY,

EXAMINATION:

Bayer ADVIA IMS (08254)

Behring OPUS Magnum (07794)

Behring OPUS Plus (07795)

TOSOH AIA–600 II (61464)

ANALYTE: Triiodothyronine Uptake

(T3U) (TU) (6120)

TEST SYSTEM, ASSAY,

EXAMINATION:

Behring OPUS Magnum (07794)

Behring OPUS Plus (07795)

Roche Diagnostics Cobas INTEGRA

400 (55634)

Roche Diagnostics Cobas INTEGRA

700 (55643)

ANALYTE: Triiodothyronine, Free

(FT3) (6121)

TEST SYSTEM, ASSAY,

EXAMINATION:

Bayer ADVIA IMS (08254)

TOSOH AIA–600 II (61464)

SPECIALITY/SUBSPECIALITY: General

Chemistry

ANALYTE: Acid Phosphatase (0407)

TEST SYSTEM, ASSAY,

EXAMINATION:

Abbott Aeroset (04798)

ANALYTE: Alanine Aminotransferase

(ALT) (SGPT) (0404)

TEST SYSTEM, ASSAY,

EXAMINATION:

Bayer ADVIA IMS (08254)

Cholestech L.D.X. (10170)

Roche Diagnostics Cobas INTEGRA

400 (55634)

Roche Diagnostics Cobas INTEGRA

700 (55643)

ANALYTE: Albumin (0414)

TEST SYSTEM, ASSAY,

EXAMINATION:

Roche Diagnostics Cobas INTEGRA

400 (55634)

Roche Diagnostics Cobas INTEGRA

700 (55643)

ANALYTE: Alkaline Phosphatase (ALP)

(0416)

TEST SYSTEM, ASSAY,

EXAMINATION:

Bayer ADVIA IMS (08254)

Roche Diagnostics Cobas INTEGRA

400 (55634)

Roche Diagnostics Cobas INTEGRA

700 (55643)

ANALYTE: Ammonia, Plasma/Serum

(0427)

TEST SYSTEM, ASSAY,

EXAMINATION:

CARESIDE CareSide Analyzer (10445)

Roche Diagnostics Cobas INTEGRA

400 (55634)

Roche Diagnostics Cobas INTEGRA

700 (55643)

ANALYTE: Amylase (0429)

TEST SYSTEM, ASSAY,

EXAMINATION:

Bayer ADVIA IMS (08254)

Roche Diagnostics Cobas INTEGRA

400 (55634)

Roche Diagnostics Cobas INTEGRA

700 (55643)

ANALYTE: Amylase, pancreatic

isoenzymes (p-Amylase) (0500)

TEST SYSTEM, ASSAY,

EXAMINATION:

Roche Diagnostics Cobas INTEGRA

400 (55634)

Roche Diagnostics Cobas INTEGRA

700 (55643)

ANALYTE: Apolipoprotein A1 (0462)

TEST SYSTEM, ASSAY,

EXAMINATION:

Abbott Aeroset (04798)

Beckman Synchron CX4 {Kamiya KAssay} (08245)

Beckman Synchron CX5 {Kamiya KAssay} (08246)

Beckman Synchron CX7 {Kamiya KAssay} (08247)

Instrumentation Laboratory ILAB

1800 {Kamiya K-Assay} (28572)

Instrumentation Laboratory ILAB 600

{Kamiya K-Assay} (28571)

Instrumentation Laboratory ILAB 900

{Kamiya K-Assay} (28573)

Olympus AU 1000 {Kamiya K-Assay}

(46328)

Olympus AU 5000 {Kamiya K-Assay}

(46330)

Olympus AU 600 {Kamiya K-Assay}

(46326)

Olympus AU 800 {Kamiya K-Assay}

(46327)

Olympus Reply/AU 560 {Kamiya KAssay} (46329)

Roche Diagnostics Cobas FARA

{Kamiya K-Assay} (55663)

Roche Diagnostics Cobas FARA II

{Kamiya K-Assay} (55664)

Roche Diagnostics Cobas INTEGRA

400 (55634)

Roche Diagnostics Cobas INTEGRA

25798 Federal Register / Vol. 65, No. 86 / Wednesday, May 3, 2000 / Notices

700 (55643)

Roche Diagnostics Cobas Mira

{Kamiya K-Assay} (55654)

Roche Diagnostics Cobas Mira Plus

{Kamiya K-Assay} (55656)

Roche Diagnostics Cobas Mira S

{Kamiya K-Assay} (55655)

Roche Diagnostics Hitachi 704

{Kamiya K-Assay} (55657)

Roche Diagnostics Hitachi 717

{Kamiya K-Assay} (55658)

Roche Diagnostics Hitachi 747

{Kamiya K-Assay} (55660)

Roche Diagnostics Hitachi 911

{Kamiya K-Assay} (55661)

Roche Diagnostics Hitachi 914

{Kamiya K-Assay} (55659)

Roche Diagnostics Hitachi 917

{Kamiya K-Assay} (55662)

Technicon AXON {Kamiya K-Assay}

(61460)

Wako Diagnostics 30R {Kamiya KAssay} (70236)

ANALYTE: Apolipoprotein B (0457)

TEST SYSTEM, ASSAY,

EXAMINATION:

Abbott Aeroset (04798)

Beckman Synchron CX4 {Kamiya KAssay} (08245)

Beckman Synchron CX5 {Kamiya KAssay} (08246)

Beckman Synchron CX7 {Kamiya KAssay} (08247)

Instrumentation Laboratory ILAB

1800 {Kamiya K-Assay} (28572)

Instrumentation Laboratory ILAB 600

{Kamiya K-Assay} (28571)

Instrumentation Laboratory ILAB 900

{Kamiya K-Assay} (28573)

Olympus AU 1000 {Kamiya K-Assay}

(46328)

Olympus AU 5000 {Kamiya K-Assay}

(46330)

Olympus AU 600 {Kamiya K-Assay}

(46326)

Olympus AU 800 {Kamiya K-Assay}

(46327)

Olympus Reply/AU 560 {Kamiya KAssay} (46329)

Roche Diagnostics Cobas FARA

{Kamiya K-Assay} (55663)

Roche Diagnostics Cobas FARA II

{Kamiya K-Assay} (55664)

Roche Diagnostics Cobas INTEGRA

400 (55634)

Roche Diagnostics Cobas INTEGRA

700 (55643)

Roche Diagnostics Cobas Mira

{Kamiya K-Assay} (55654)

Roche Diagnostics Cobas Mira Plus

{Kamiya K-Assay} (55656)

Roche Diagnostics Cobas Mira S

{Kamiya K-Assay} (55655)

Roche Diagnostics Hitachi 704

{Kamiya K-Assay} (55657)

Roche Diagnostics Hitachi 717

{Kamiya K-Assay} (55658)

Roche Diagnostics Hitachi 747

{Kamiya K-Assay} (55660)

Roche Diagnostics Hitachi 911

{Kamiya K-Assay} (55661)

Roche Diagnostics Hitachi 914

{Kamiya K-Assay} (55659)

Roche Diagnostics Hitachi 917

{Kamiya K-Assay} (55662)

Technicon AXON {Kamiya K-Assay}

(61460)

Wako Diagnostics 30R {Kamiya KAssay} (70236)

ANALYTE: Aspartate Aminotransferase

(AST) (SGOT) (0405)

TEST SYSTEM, ASSAY,

EXAMINATION:

Bayer ADVIA IMS (08254)

Roche Diagnostics Cobas INTEGRA

400 (55634)

Roche Diagnostics Cobas INTEGRA

700 (55643)

ANALYTE: Bilirubin, Direct (0704)

TEST SYSTEM, ASSAY,

EXAMINATION:

CARESIDE CareSide Analyzer (10445)

Roche Diagnostics Cobas INTEGRA

400 (55634)

Roche Diagnostics Cobas INTEGRA

700 (55643)

ANALYTE: Bilirubin, Neonatal (0705)

TEST SYSTEM, ASSAY,

EXAMINATION:

Arrows UB Analyzer UA–2 (04888)

ANALYTE: Bilirubin, Total (0706)

TEST SYSTEM, ASSAY,

EXAMINATION:

Roche Diagnostics Cobas INTEGRA

400 (55634)

Roche Diagnostics Cobas INTEGRA

700 (55643)

ANALYTE: Bilirubin, Unbound (0748)

TEST SYSTEM, ASSAY,

EXAMINATION:

Arrows UB Analyzer UA–2 (04888)

ANALYTE: Blood Gases (0708)

TEST SYSTEM, ASSAY,

EXAMINATION:

Instrumentation Laboratory GEM

Premier 3000 (28583)

Nova Stat Profile M7 (43129)

Radiometer ABL NPT7 Series

Analyzers (55645)

ANALYTE: C-Peptide (1040)

TEST SYSTEM, ASSAY,

EXAMINATION:

TOSOH AIA–600 II (61464)

ANALYTE: Calcium, Ionized (1004)

TEST SYSTEM, ASSAY,

EXAMINATION:

Instrumentation Laboratory GEM

Premier 3000 (28583)

Nova Stat Profile M7 (43129)

ANALYTE: Calcium, Total (1005)

TEST SYSTEM, ASSAY,

EXAMINATION:

Bayer ADVIA IMS (08254)

Roche Diagnostics Cobas INTEGRA

400 (55634)

Roche Diagnostics Cobas INTEGRA

700 (55643)

ANALYTE: Cancer Antigen 125 (CA

125) (1049)

TEST SYSTEM, ASSAY,

EXAMINATION:

TOSOH AIA–600 II (61464)

ANALYTE: Carbon Dioxide, Total (CO2)

(1003)

TEST SYSTEM, ASSAY,

EXAMINATION:

Abaxis Piccolo Portable Blood

Analyzer (04608)

CARESIDE CareSide Analyzer (10445)

Roche Diagnostics Cobas INTEGRA

400 (55634)

Roche Diagnostics Cobas INTEGRA

700 (55643)

ANALYTE: Carcinoembryonic Antigen

(CEA) (1013)

TEST SYSTEM, ASSAY,

EXAMINATION:

TOSOH AIA–600 II (61464)

ANALYTE: Ceruloplasmin (1015)

TEST SYSTEM, ASSAY,

EXAMINATION:

Roche Diagnostics Cobas INTEGRA

400 (55634)

Roche Diagnostics Cobas INTEGRA

700 (55643)

ANALYTE: Chloride (1018)

TEST SYSTEM, ASSAY,

EXAMINATION:

Nova Stat Profile M7 (43129)

Roche Diagnostics Cobas INTEGRA

400 (55634)

Roche Diagnostics Cobas INTEGRA

700 (55643)

ANALYTE: Cholesterol (1020)

TEST SYSTEM, ASSAY,

EXAMINATION:

Bayer ADVIA IMS (08254)

Roche Diagnostics Cobas INTEGRA

400 (55634)

Roche Diagnostics Cobas INTEGRA

700 (55643)

ANALYTE: Cholinesterase (1021)

TEST SYSTEM, ASSAY,

EXAMINATION:

EQM Research Test-mate ChE

Cholinesterase Test System {AChE/

PChE Assay} (16194)

Roche Diagnostics Cobas INTEGRA

700 (55643)

ANALYTE: Creatine Kinase (CK) (1034)

Federal Register / Vol. 65, No. 86 / Wednesday, May 3, 2000 / Notices 25799

TEST SYSTEM, ASSAY,

EXAMINATION:

Abaxis Piccolo Portable Blood

Analyzer (04608)

Bayer ADVIA IMS (08254)

Roche Diagnostics Cobas INTEGRA

400 (55634)

Roche Diagnostics Cobas INTEGRA

700 (55643)

ANALYTE: Creatine Kinase MB

Fraction (CKMB) (1002)

TEST SYSTEM, ASSAY,

EXAMINATION:

Roche Diagnostics Cobas INTEGRA

400 (55634)

Roche Diagnostics Cobas INTEGRA

700 (55643)

TOSOH AIA–600 II (61464)

ANALYTE: Creatinine (1035)

TEST SYSTEM, ASSAY,

EXAMINATION:

Bayer ADVIA IMS (08254)

Nova Stat Profile M7 (43129)

Roche Diagnostics Cobas INTEGRA

400 (55634)

Roche Diagnostics Cobas INTEGRA

700 (55643)

ANALYTE: Deoxyhemoglobin (Reduced

Hemoglobin) (1318)

TEST SYSTEM, ASSAY,

EXAMINATION:

Radiometer ABL NPT7 Series

Analyzers (55645)

ANALYTE: Ferritin (1902)

TEST SYSTEM, ASSAY,

EXAMINATION:

Bayer ADVIA IMS (08254)

Behring OPUS Magnum (07794)

Behring OPUS Plus (07795)

Nichols Institute Advantage

Chemiluminescence System (43122)

Roche Diagnostics Cobas INTEGRA

400 (55634)

Roche Diagnostics Cobas INTEGRA

700 (55643)

TOSOH AIA–600 II (61464)

ANALYTE: Folate (Folic acid) (1907)

TEST SYSTEM, ASSAY,

EXAMINATION:

TOSOH AIA–600 II (auto pretreatment) (61465)

TOSOH AIA–600 II (manual pretreatment) (61466)

ANALYTE: Fructosamine (1914)

TEST SYSTEM, ASSAY,

EXAMINATION:

Roche Diagnostics Cobas INTEGRA

400 (55634)

Roche Diagnostics Cobas INTEGRA

700 (55643)

ANALYTE: Gamma Glutamyl

Transferase (GGT) (2201)

TEST SYSTEM, ASSAY,

EXAMINATION:

Bayer ADVIA IMS (08254)

Roche Diagnostics Cobas INTEGRA

400 (55634)

Roche Diagnostics Cobas INTEGRA

700 (55643)

ANALYTE: Glucose (2203)

TEST SYSTEM, ASSAY,

EXAMINATION:

AVL OPTI Critical Care Analyzer

(04778)

Bayer ADVIA IMS (08254)

Nova Stat Profile M7 (43129)

Roche Diagnostics Cobas INTEGRA

400 (55634)

Roche Diagnostics Cobas INTEGRA

700 (55643)

ANALYTE: Glycosylated Hemoglobin

(Hgb A1C) (2204)

TEST SYSTEM, ASSAY,

EXAMINATION:

Roche Diagnostics Cobas INTEGRA

400 (55634)

Roche Diagnostics Cobas INTEGRA

700 (55643)

ANALYTE: HDL Cholesterol (2550)

TEST SYSTEM, ASSAY,

EXAMINATION:

Abbott Spectrum {DCL Dextran

Sulfate/Magnesium Uni-Paks}

(04642)

Abbott VP {DCL Dextran Sulfate/

Magnesium Uni-Paks} (04643)

Beckman Synchron CX4 {Kamiya KAssay} (08245)

Beckman Synchron CX5 {Kamiya KAssay} (08246)

Beckman Synchron CX7 {Kamiya KAssay} (08247)

Chiron Diagnostics 550 Express {DCL

Dextran Sulfate/Magnesium UniPaks} (10377)

Chiron Diagnostics 550 Express

{Kamiya K-Assay} (10493)

Ciba Corning 550 Express {DCL

Dextran Sulfate/Magnesium UniPaks} (10327)

Dade Dimension {Randox Direct

HDL} (13599)

Dade Dimension AR {Randox Direct

HDL} (13601)

Dade Dimension ES {Randox Direct

HDL} (13603)

Dade Dimension RxL {Randox Direct

HDL} (13605)

Dade Dimension XL {Randox Direct

HDL} (13607)

Electronucleonics Gemini {DCL

Dextran Sulfate/Magnesium UniPaks} (16119)

Electronucleonics Gemstar {DCL

Dextran Sulfate/Magnesium UniPaks} (16120)

Instrumentation Laboratory IL

Monarch {DCL Dextran Sulfate/

Magnesium Uni-Paks} (28435)

Instrumentation Laboratory ILAB

1800 {Kamiya K-Assay} (28572)

Instrumentation Laboratory ILAB 900

{Kamiya K-Assay} (28573)

Olympus AU 5000 {DCL Dextran

Sulfate/Magnesium Uni-Paks}

(46213)

Olympus AU 800 {Kamiya K-Assay}

(46327)

Roche Diagnostics Cobas Bio {DCL

Dextran Sulfate/Magnesium UniPaks} (55189)

Roche Diagnostics Cobas FARA {DCL

Dextran Sulfate/Magnesium UniPaks} (55191)

Roche Diagnostics Cobas INTEGRA

400 (55634)

Roche Diagnostics Cobas INTEGRA

700 (55643)

Roche Diagnostics Cobas INTEGRA

700 {COBAS INTEGRA HDLCholesterol Direct} (55644)

Roche Diagnostics Cobas Mira {DCL

Dextran Sulfate/Magnesium UniPaks} (55193)

Roche Diagnostics Cobas Mira

{Kamiya K-Assay} (55654)

Roche Diagnostics Cobas Mira S {DCL

Dextran Sulfate/Magnesium UniPaks} (55195)

Roche Diagnostics Cobas Mira S

{Kamiya K-Assay} (55655)

Roche Diagnostics Hitachi 704 {DCL

Dextran Sulfate/Magnesium UniPaks} (55378)

Roche Diagnostics Hitachi 704

{Kamiya K-Assay} (55657)

Roche Diagnostics Hitachi 717 {DCL

Dextran Sulfate/Magnesium UniPaks} (55424)

Roche Diagnostics Hitachi 717

{Kamiya K-Assay} (55658)

Roche Diagnostics Hitachi 737 {DCL

Dextran Sulfate/Magnesium UniPaks} (55466)

Roche Diagnostics Hitachi 737

{Kamiya K-Assay} (55666)

Roche Diagnostics Hitachi 747

{Kamiya K-Assay} (55660)

Roche Diagnostics Hitachi 911

{Kamiya K-Assay} (55661)

Roche Diagnostics Hitachi 912

{Randox Direct HDL} (55684)

Roche Diagnostics Hitachi 917

{Kamiya K-Assay} (55662)

StatChem StatTest Sysem (58269)

Technicon RA 100 {Kamiya K-Assay}

(61456)

Technicon RA 1000 {DCL Dextran

Sulfate/Magnesium Uni-Paks}

(61223)

Technicon RA 1000 {Kamiya KAssay} (61457)

Technicon RA 2000 {Kamiya KAssay} (61458)

Technicon RA 500 {DCL Dextran

Sulfate/Magnesium Uni-Paks}

(61221)

25800 Federal Register / Vol. 65, No. 86 / Wednesday, May 3, 2000 / Notices

Technicon RA 500 {Kamiya K-Assay}

(61459)

Technicon RA XT {DCL Dextran

Sulfate/Magnesium Uni-Paks}

(61225)

Technicon RA XT {Kamiya K-Assay}

(61455)

ANALYTE: Haptoglobin (2511)

TEST SYSTEM, ASSAY,

EXAMINATION:

Abbott Aeroset (04798)

Beckman Synchron CX4 {Kamiya KAssay} (08245)

Beckman Synchron CX5 {Kamiya KAssay} (08246)

Beckman Synchron CX7 {Kamiya KAssay} (08247)

Instrumentation Laboratory ILAB

1800 {Kamiya K-Assay} (28572)

Instrumentation Laboratory ILAB 600

{Kamiya K-Assay} (28571)

Instrumentation Laboratory ILAB 900

{Kamiya K-Assay} (28573)

Olympus AU 1000 {Kamiya K-Assay}

(46328)

Olympus AU 600 {Kamiya K-Assay}

(46326)

Olympus AU 800 {Kamiya K-Assay}

(46327)

Olympus Reply/AU 560 {Kamiya KAssay} (46329)

Roche Diagnostics Cobas FARA

{Kamiya K-Assay} (55663)

Roche Diagnostics Cobas FARA II

{Kamiya K-Assay} (55664)

Roche Diagnostics Cobas INTEGRA

400 (55634)

Roche Diagnostics Cobas INTEGRA

700 (55643)

Roche Diagnostics Cobas Mira

{Kamiya K-Assay} (55654)

Roche Diagnostics Cobas Mira Plus

{Kamiya K-Assay} (55656)

Roche Diagnostics Cobas Mira S

{Kamiya K-Assay} (55655)

Roche Diagnostics Hitachi 704

{Kamiya K-Assay} (55657)

Roche Diagnostics Hitachi 717

{Kamiya K-Assay} (55658)

Roche Diagnostics Hitachi 747

{Kamiya K-Assay} (55660)

Roche Diagnostics Hitachi 911

{Kamiya K-Assay} (55661)

Roche Diagnostics Hitachi 914

{Kamiya K-Assay} (55659)

Roche Diagnostics Hitachi 917

{Kamiya K-Assay} (55662)

Wako Diagnostics 30R {Kamiya KAssay} (70236)

ANALYTE: Hemoglobin A2 (2535)

TEST SYSTEM, ASSAY,

EXAMINATION:

Bio-Rad VARIANT II BetaThalassemia Short Program (08229)

ANALYTE: Hemoglobin F (2516)

TEST SYSTEM, ASSAY,

EXAMINATION:

Bio-Rad VARIANT II BetaThalassemia Short Program (08229)

ANALYTE: Hemoglobin Fractions

(2544)

TEST SYSTEM, ASSAY,

EXAMINATION:

Bio-Rad VARIANT II BetaThalassemia Short Program (08229)

ANALYTE: Hemoglobin S (2536)

TEST SYSTEM, ASSAY,

EXAMINATION:

True Medix Sickle-Scan HbS (61138)

ANALYTE: Iron (2814)

TEST SYSTEM, ASSAY,

EXAMINATION:

Bayer ADVIA IMS (08254)

Roche Diagnostics Cobas INTEGRA

400 (55634)

Roche Diagnostics Cobas INTEGRA

700 (55643)

ANALYTE: Iron Binding Capacity,

Unsat. (UIBC) no pretreat. (2823)

TEST SYSTEM, ASSAY,

EXAMINATION:

Roche Diagnostics Cobas INTEGRA

400 (55634)

Roche Diagnostics Cobas INTEGRA

700 (55643)

ANALYTE: LDL Cholesterol (3748)

TEST SYSTEM, ASSAY,

EXAMINATION:

Beckman Synchron CX 4 {Randox

Direct LDL} (08256)

Beckman Synchron CX 5 {Randox

Direct LDL} (08257)

Beckman Synchron CX 7 {Randox

Direct LDL} (08258)

Dade Dimension {Randox Direct LDL}

(13598)

Dade Dimension AR {Randox Direct

LDL} (13600)

Dade Dimension ES {Randox Direct

LDL} (13602)

Dade Dimension RxL {Randox Direct

LDL} (13604)

Dade Dimension XL {Randox Direct

LDL} (13606)

Olympus AU 600 {Genzyme Ngeneous LDL–ST} (46324)

Roche Diagnostics Cobas INTEGRA

400 (55634)

Roche Diagnostics Cobas INTEGRA

700 (55643)

Roche Diagnostics Cobas Mira

{Randox Direct LDL} (55674)

Roche Diagnostics Cobas Mira Plus

{Randox Direct LDL} (55675)

Roche Diagnostics Cobas Mira S

{Randox Direct LDL} (55676)

Roche Diagnostics Hitachi 704

{Randox Direct LDL} (55677)

Roche Diagnostics Hitachi 717

{Randox Direct LDL} (55678)

Roche Diagnostics Hitachi 737

{Randox Direct LDL} (55679)

Roche Diagnostics Hitachi 747

{Randox Direct LDL} (55680)

Roche Diagnostics Hitachi 911

{Randox Direct LDL} (55681)

Roche Diagnostics Hitachi 912

{Randox Direct LDL} (55682)

Roche Diagnostics Hitachi 917

{Randox Direct LDL} (55683)

ANALYTE: Lactate Dehydrogenase

(LDH) (3701)

TEST SYSTEM, ASSAY,

EXAMINATION:

Abbott Aeroset (04798)

Bayer ADVIA IMS (08254)

Roche Diagnostics Cobas INTEGRA

400 (55634)

Roche Diagnostics Cobas INTEGRA

700 (55643)

ANALYTE: Lactate Dehydrogenase

Heart Fraction (LDH–1) (3702)

TEST SYSTEM, ASSAY,

EXAMINATION:

Roche Diagnostics Cobas INTEGRA

700 (55643)

ANALYTE: Lactic Acid (Lactate) (3704)

TEST SYSTEM, ASSAY,

EXAMINATION:

Abbott Aeroset (04798)

Nova Stat Profile M7 (43129)

Roche Diagnostics Cobas INTEGRA

400 (55634)

Roche Diagnostics Cobas INTEGRA

700 (55643)

ANALYTE: Lipase (3711)

TEST SYSTEM, ASSAY,

EXAMINATION:

Roche Diagnostics Cobas INTEGRA

400 (55634)

Roche Diagnostics Cobas INTEGRA

700 (55643)

ANALYTE: Lipoprotein(a) (Lp(a)) (3755)

TEST SYSTEM, ASSAY,

EXAMINATION:

Roche Diagnostics Hitachi 911

{DiaSorin SPQ Ab Rgt Set for Lp(a)}

(55685)

ANALYTE: Magnesium (4002)

TEST SYSTEM, ASSAY,

EXAMINATION:

CARESIDE CareSide Analyzer (10445)

Roche Diagnostics Cobas INTEGRA

400 (55634)

Roche Diagnostics Cobas INTEGRA

700 (55643)

ANALYTE: Methemoglobin (4032)

TEST SYSTEM, ASSAY,

EXAMINATION:

Radiometer ABL NPT7 Series

Analyzers (55645)

ANALYTE: Microalbumin (4019)

TEST SYSTEM, ASSAY,

EXAMINATION:

Abbott Aeroset (04798)

Federal Register / Vol. 65, No. 86 / Wednesday, May 3, 2000 / Notices 25801

ANALYTE: Myoglobin (4023)

TEST SYSTEM, ASSAY,

EXAMINATION:

Behring OPUS Magnum (07794)

Behring OPUS Plus (07795)

Roche Diagnostics Cobas INTEGRA

400 (55634)

Roche Diagnostics Cobas INTEGRA

700 (55643)

Roche Diagnostics Cobas Mira

{Spectral Diagnostics Multiquant}

(55653)

TOSOH AIA–600 II (61464)

ANALYTE: Oxyhemoglobin/Oxygen

Saturation (4604)

TEST SYSTEM, ASSAY,

EXAMINATION:

Nova Stat Profile M7 (43129)

Radiometer ABL NPT7 Series

Analyzers (55645)

ANALYTE: PCO2 (4983)

TEST SYSTEM, ASSAY,

EXAMINATION:

Instrumentation Laboratory GEM

Premier 3000 (28583)

Nova Stat Profile M7 (43129)

Radiometer ABL NPT7 Series

Analyzers (55645)

ANALYTE: PO2 (4984)

TEST SYSTEM, ASSAY,

EXAMINATION:

Instrumentation Laboratory GEM

Premier 3000 (28583)

Nova Stat Profile M7 (43129)

Radiometer ABL NPT7 Series

Analyzers (55645)

ANALYTE: Phosphorus (4906)

TEST SYSTEM, ASSAY,

EXAMINATION:

Roche Diagnostics Cobas INTEGRA

400 (55634)

Roche Diagnostics Cobas INTEGRA

700 (55643)

ANALYTE: Potassium (4910)

TEST SYSTEM, ASSAY,

EXAMINATION:

Instrumentation Laboratory GEM

Premier 3000 (28583)

Nova Stat Profile M7 (43129)

Roche Diagnostics Cobas INTEGRA

400 (55634)

Roche Diagnostics Cobas INTEGRA

700 (55643)

ANALYTE: Prealbumin (4911)

TEST SYSTEM, ASSAY,

EXAMINATION:

Abbott Aeroset (04798)

Roche Diagnostics Cobas INTEGRA

400 (55634)

Roche Diagnostics Cobas INTEGRA

700 (55643)

ANALYTE: Prostatic Acid Phosphatase

(PAP) (4918)

TEST SYSTEM, ASSAY,

EXAMINATION:

Abbott Aeroset (04798)

Roche Diagnostics Cobas INTEGRA

400 (55634)

Roche Diagnostics Cobas INTEGRA

700 (55643)

TOSOH AIA–600 II (61464)

ANALYTE: Prostatic Specific Antigen

(PSA) (4919)

TEST SYSTEM, ASSAY,

EXAMINATION:

TOSOH AIA–600 II (61464)

ANALYTE: Prostatic Specific Antigen

(PSA), Free (4990)

TEST SYSTEM, ASSAY,

EXAMINATION:

Beckman ACCESS Immunoassay

System (07914)

ANALYTE: Protein, Glycated (4963)

TEST SYSTEM, ASSAY,

EXAMINATION:

Beckman Synchron CX4 {Genzyme

GlyPro} (08234)

Beckman Synchron CX4 CE

{Genzyme GlyPro} (08235)

Beckman Synchron CX4 Delta

{Genzyme GlyPro} (08236)

Beckman Synchron CX5 {Genzyme

GlyPro} (08237)

Beckman Synchron CX5 CE

{Genzyme GlyPro} (08238)

Beckman Synchron CX5 Delta

{Genzyme GlyPro} (08239)

Beckman Synchron CX7 {Genzyme

GlyPro} (08240)

Beckman Synchron CX7 Delta

{Genzyme GlyPro} (08241)

Chiron Diagnostics 550 Express

{Genzyme GlyPro} (10488)

Olympus AU 600 {Genzyme GlyPro}

(46325)

Roche Diagnostics Hitachi 717

{Genzyme GlyPro} (55647)

Roche Diagnostics Hitachi 911

{Genzyme GlyPro} (55646)

ANALYTE: Protein, Total (4921)

TEST SYSTEM, ASSAY,

EXAMINATION:

Bayer ADVIA IMS (08254)

Roche Diagnostics Cobas INTEGRA

400 (55634)

Roche Diagnostics Cobas INTEGRA

700 (55643)

ANALYTE: Protein, Total (urine) (4972)

TEST SYSTEM, ASSAY,

EXAMINATION:

Bayer ADVIA IMS (08254)

ANALYTE: Sodium (5805)

TEST SYSTEM, ASSAY,

EXAMINATION:

Abaxis Piccolo Portable Blood

Analyzer (04608)

Instrumentation Laboratory GEM

Premier 3000 (28583)

Nova Stat Profile M7 (43129)

Roche Diagnostics Cobas INTEGRA

400 (55634)

Roche Diagnostics Cobas INTEGRA

700 (55643)

ANALYTE: Transferrin (6114)

TEST SYSTEM, ASSAY,

EXAMINATION:

Abbott Aeroset (04798)

Abbott Aeroset {Wako Transferrin}

(04880)

Bayer ADVIA IMS (08254)

Beckman Synchron CX4 {Kamiya KAssay} (08245)

Beckman Synchron CX5 {Kamiya KAssay} (08246)

Beckman Synchron CX7 {Kamiya KAssay} (08247)

Instrumentation Laboratory ILAB

1800 {Kamiya K-Assay} (28572)

Instrumentation Laboratory ILAB 600

{Kamiya K-Assay} (28571)

Instrumentation Laboratory ILAB 900

{Kamiya K-Assay} (28573)

Olympus AU 1000 {Kamiya K-Assay}

(46328)

Olympus AU 600 {Kamiya K-Assay}

(46326)

Olympus AU 800 {Kamiya K-Assay}

(46327)

Olympus Reply/AU 560 {Kamiya KAssay} (46329)

Roche Diagnostics Cobas FARA

{Kamiya K-Assay} (55663)

Roche Diagnostics Cobas FARA II

{Kamiya K-Assay} (55664)

Roche Diagnostics Cobas INTEGRA

400 (55634)

Roche Diagnostics Cobas INTEGRA

700 (55643)

Roche Diagnostics Cobas Mira

{Kamiya K-Assay} (55654)

Roche Diagnostics Cobas Mira {Wako

Transferrin} (55648)

Roche Diagnostics Cobas Mira Plus

{Kamiya K-Assay} (55656)

Roche Diagnostics Cobas Mira S

{Kamiya K-Assay} (55655)

Roche Diagnostics Hitachi 704

{Kamiya K-Assay} (55657)

Roche Diagnostics Hitachi 704 {Wako

Transferrin} (55649)

Roche Diagnostics Hitachi 717

{Kamiya K-Assay} (55658)

Roche Diagnostics Hitachi 717 {Wako

Transferrin} (55650)

Roche Diagnostics Hitachi 736

{Kamiya K-Assay} (55665)

Roche Diagnostics Hitachi 747

{Kamiya K-Assay} (55660)

Roche Diagnostics Hitachi 911

{Kamiya K-Assay} (55661)

Roche Diagnostics Hitachi 911 {Wako

Transferrin} (55651)

Roche Diagnostics Hitachi 914

{Kamiya K-Assay} (55659)

25802 Federal Register / Vol. 65, No. 86 / Wednesday, May 3, 2000 / Notices

Roche Diagnostics Hitachi 917

{Kamiya K-Assay} (55662)

Roche Diagnostics Hitachi 917 {Wako

Transferrin} (55652)

Wako Diagnostics 30R (70002)

Wako Diagnostics 30R {Kamiya KAssay} (70236)

ANALYTE: Transferrin Receptor (TfR)

(6158)

TEST SYSTEM, ASSAY,

EXAMINATION:

Behring Nephelometer {N Latex sTfR}

(08225)

Behring Nephelometer 100 {N Latex

sTfR} (08226)

Behring Nephelometer II {N Latex

sTfR} (08227)

ANALYTE: Triglyceride (6118)

TEST SYSTEM, ASSAY,

EXAMINATION:

Bayer ADVIA IMS (08254)

Roche Diagnostics Cobas INTEGRA

400 (55634)

Roche Diagnostics Cobas INTEGRA

700 (55643)

ANALYTE: Troponin-I (Cardiac) (6153)

TEST SYSTEM, ASSAY,

EXAMINATION:

Ortho-Clinical Diagnostics Vitros ECi

(46279)

TOSOH AIA–600 II (61464)

ANALYTE: Urea (BUN) (6403)

TEST SYSTEM, ASSAY,

EXAMINATION:

AVL OPTI Critical Care Analyzer

(04778)

Bayer ADVIA IMS (08254)

Nova Stat Profile M7 (43129)

Roche Diagnostics Cobas INTEGRA

400 (55634)

Roche Diagnostics Cobas INTEGRA

700 (55643)

ANALYTE: Uric Acid (6404)

TEST SYSTEM, ASSAY,

EXAMINATION:

Roche Diagnostics Cobas INTEGRA

400 (55634)

Roche Diagnostics Cobas INTEGRA

700 (55643)

ANALYTE: Vitamin B12 (6707)

TEST SYSTEM, ASSAY,

EXAMINATION:

TOSOH AIA–600 II (auto pretreatment) (61465)

TOSOH AIA–600 II (manual pretreatment) (61466)

ANALYTE: pH (4982)

TEST SYSTEM, ASSAY,

EXAMINATION:

Instrumentation Laboratory GEM

Premier 3000 (28583)

Nova Stat Profile M7 (43129)

Radiometer ABL NPT7 Series

Analyzers (55645)

SPECIALITY/SUBSPECIALITY: General

Immunology

ANALYTE: Allergen specific IgE (0417)

TEST SYSTEM, ASSAY,

EXAMINATION:

Hycor HY–TEC Automated EIA

System {Specific IgE EIA} (25314)

ANALYTE: Alpha-1–Acid Glycoprotein

(orosomucoid) (0420)

TEST SYSTEM, ASSAY,

EXAMINATION:

Beckman Synchron CX4 {Kamiya KAssay} (08245)

Beckman Synchron CX5 {Kamiya KAssay} (08246)

Beckman Synchron CX7 {Kamiya KAssay} (08247)

Instrumentation Laboratory ILAB

1800 {Kamiya K-Assay} (28572)

Instrumentation Laboratory ILAB 600

{Kamiya K-Assay} (28571)

Instrumentation Laboratory ILAB 900

{Kamiya K-Assay} (28573)

Olympus AU 1000 {Kamiya K-Assay}

(46328)

Olympus AU 600 {Kamiya K-Assay}

(46326)

Olympus AU 800 {Kamiya K-Assay}

(46327)

Roche Diagnostics Cobas FARA

{Kamiya K-Assay} (55663)

Roche Diagnostics Cobas FARA II

{Kamiya K-Assay} (55664)

Roche Diagnostics Cobas INTEGRA

400 (55634)

Roche Diagnostics Cobas INTEGRA

700 (55643)

Roche Diagnostics Cobas Mira

{Kamiya K-Assay} (55654)

Roche Diagnostics Cobas Mira Plus

{Kamiya K-Assay} (55656)

Roche Diagnostics Cobas Mira S

{Kamiya K-Assay} (55655)

Roche Diagnostics Hitachi 704

{Kamiya K-Assay} (55657)

Roche Diagnostics Hitachi 717

{Kamiya K-Assay} (55658)

Roche Diagnostics Hitachi 747

{Kamiya K-Assay} (55660)

Roche Diagnostics Hitachi 911

{Kamiya K-Assay} (55661)

Roche Diagnostics Hitachi 914

{Kamiya K-Assay} (55659)

Roche Diagnostics Hitachi 917

{Kamiya K-Assay} (55662)

Wako Diagnostics 30R {Kamiya KAssay} (70236)

ANALYTE: Alpha-1–Antitrypsin

(0421)

TEST SYSTEM, ASSAY,

EXAMINATION:

Beckman Synchron CX4 {Kamiya KAssay} (08245)

Beckman Synchron CX5 {Kamiya KAssay} (08246)

Beckman Synchron CX7 {Kamiya KAssay} (08247)

Instrumentation Laboratory ILAB

1800 {Kamiya K-Assay} (28572)

Instrumentation Laboratory ILAB 600

{Kamiya K-Assay} (28571)

Instrumentation Laboratory ILAB 900

{Kamiya K-Assay} (28573)

Olympus AU 1000 {Kamiya K-Assay}

(46328)

Olympus AU 600 {Kamiya K-Assay}

(46326)

Olympus AU 800 {Kamiya K-Assay}

(46327)

Roche Diagnostics Cobas FARA

{Kamiya K-Assay} (55663)

Roche Diagnostics Cobas FARA II

{Kamiya K-Assay} (55664)

Roche Diagnostics Cobas INTEGRA

400 (55634)

Roche Diagnostics Cobas INTEGRA

700 (55643)

Roche Diagnostics Cobas Mira

{Kamiya K-Assay} (55654)

Roche Diagnostics Cobas Mira Plus

{Kamiya K-Assay} (55656)

Roche Diagnostics Cobas Mira S

{Kamiya K-Assay} (55655)

Roche Diagnostics Hitachi 704

{Kamiya K-Assay} (55657)

Roche Diagnostics Hitachi 717

{Kamiya K-Assay} (55658)

Roche Diagnostics Hitachi 747

{Kamiya K-Assay} (55660)

Roche Diagnostics Hitachi 911

{Kamiya K-Assay} (55661)

Roche Diagnostics Hitachi 914

{Kamiya K-Assay} (55659)

Roche Diagnostics Hitachi 917

{Kamiya K-Assay} (55662)

Wako Diagnostics 30R {Kamiya KAssay} (70236)

ANALYTE: Alpha-Fetoprotein—Tumor

Marker (0424)

TEST SYSTEM, ASSAY,

EXAMINATION:

TOSOH AIA–600 II (61464)

ANALYTE: Anti-Cardiolipin Antibodies

(0434)

TEST SYSTEM, ASSAY,

EXAMINATION:

Hycor HY–TEC Automated EIA

System {Anti-Cardiolipin IgG}

(25310)

Hycor HY–TEC Automated EIA

System {Anti-Cardiolipin IgM}

(25311)

ANALYTE: Anti-Gliadin Antibodies

(0528)

TEST SYSTEM, ASSAY,

EXAMINATION:

Hycor HY–TEC Automated EIA

System {Anti-Gliadin IgA} (25305)

Hycor HY–TEC Automated EIA

Federal Register / Vol. 65, No. 86 / Wednesday, May 3, 2000 / Notices 25803

System {Anti-Gliadin IgG} (25303)

Sigma Diagnostics APTUS {Gliadin

IgG} (58594)

ANALYTE: Anti-Glomerular Basement

Membrane (GBM) Antibodies (0524)

TEST SYSTEM, ASSAY,

EXAMINATION:

Hycor HY–TEC Automated EIA

System {Anti-GBM ELISA} (25301)

ANALYTE: Anti-Myeloperoxidase

(MPO) Antibodies (0505)

TEST SYSTEM, ASSAY,

EXAMINATION:

Diamedix MAGO Plus {Diamedix

Immunosimplicity (Is)–MPO (P–

ANCA) IgG} (13589)

ANALYTE: Anti-Parietal Cell

Antibodies (0442)

TEST SYSTEM, ASSAY,

EXAMINATION:

Hycor HY–TEC Automated EIA

System {Anti-GPC ELISA} (25299)

ANALYTE: Anti-Proteinase-3 (PR–3)

Antibodies (0525)

TEST SYSTEM, ASSAY,

EXAMINATION:

Diamedix MAGO Plus {Diamedix

Immunosimplicity (Is)-anti-PR–3

(C–ANCA) IgG} (13586)

ANALYTE: Anti-Streptolysin O (ASO)

(0452)

TEST SYSTEM, ASSAY,

EXAMINATION:

CENOGENICS ACCULYSIN–O

(10485)

Roche Diagnostics Cobas INTEGRA

400 (55634)

Roche Diagnostics Cobas INTEGRA

700 (55643)

ANALYTE: Anti-Thyroglobulin

Antibodies (0453)

TEST SYSTEM, ASSAY,

EXAMINATION:

Diamedix MAGO Plus {Diamedix

Immunosimplicity (Is)-anti-TG IgG}

(13590)

Nichols Institute Advantage

Chemiluminescence System (43122)

TOSOH AIA–600 II (61464)

ANALYTE: Anti-Thyroid Peroxidase

(TPO) Antibodies (0527)

TEST SYSTEM, ASSAY,

EXAMINATION:

TOSOH AIA–600 II (61464)

ANALYTE: Beta-2 microglobulin (0703)

TEST SYSTEM, ASSAY,

EXAMINATION:

TOSOH AIA–600 II (61464)

ANALYTE: C-Reactive Protein (CRP)

(1001)

TEST SYSTEM, ASSAY,

EXAMINATION:

Abbott Aeroset (04798)

Olympus AU 800 (46110)

Roche Diagnostics Cobas INTEGRA

400 (55634)

Roche Diagnostics Cobas INTEGRA

700 (55643)

ANALYTE: Cold Agglutinins (1072)

TEST SYSTEM, ASSAY,

EXAMINATION:

All Manual Macroscopic agglutination

screen/titer procedures (04890)

ANALYTE: Complement C3 (1029)

TEST SYSTEM, ASSAY,

EXAMINATION:

Abbott Aeroset (04798)

Bayer ADVIA IMS (08254)

Beckman Synchron CX4 {Kamiya KAssay} (08245)

Beckman Synchron CX5 {Kamiya KAssay} (08246)

Beckman Synchron CX7 {Kamiya KAssay} (08247)

Instrumentation Laboratory ILAB

1800 {Kamiya K-Assay} (28572)

Instrumentation Laboratory ILAB 600

{Kamiya K-Assay} (28571)

Instrumentation Laboratory ILAB 900

{Kamiya K-Assay} (28573)

Olympus AU 1000 {Kamiya K-Assay}

(46328)

Olympus AU 600 {Kamiya K-Assay}

(46326)

Olympus AU 800 {Kamiya K-Assay}

(46327)

Olympus Reply/AU 560 {Kamiya KAssay} (46329)

Roche Diagnostics Cobas FARA

{Kamiya K-Assay} (55663)

Roche Diagnostics Cobas FARA II

{Kamiya K-Assay} (55664)

Roche Diagnostics Cobas INTEGRA

400 (55634)

Roche Diagnostics Cobas INTEGRA

700 (55643)

Roche Diagnostics Cobas Mira

{Kamiya K-Assay} (55654)

Roche Diagnostics Cobas Mira Plus

{Kamiya K-Assay} (55656)

Roche Diagnostics Cobas Mira S

{Kamiya K-Assay} (55655)

Roche Diagnostics Hitachi 704

{Kamiya K-Assay} (55657)

Roche Diagnostics Hitachi 717

{Kamiya K-Assay} (55658)

Roche Diagnostics Hitachi 747

{Kamiya K-Assay} (55660)

Roche Diagnostics Hitachi 911

{Kamiya K-Assay} (55661)

Roche Diagnostics Hitachi 914

{Kamiya K-Assay} (55659)

Roche Diagnostics Hitachi 917

{Kamiya K-Assay} (55662)

Technicon AXON {Kamiya K-Assay}

(61460)

The Binding Site MININEPH

{MININEPH C3} (61364)

Wako Diagnostics 30R {Kamiya KAssay} (70236)

ANALYTE: Complement C4 (1030)

TEST SYSTEM, ASSAY,

EXAMINATION:

Abbott Aeroset (04798)

Bayer ADVIA IMS (08254)

Beckman Synchron CX4 {Kamiya KAssay} (08245)

Beckman Synchron CX5 {Kamiya KAssay} (08246)

Beckman Synchron CX7 {Kamiya KAssay} (08247)

Instrumentation Laboratory ILAB

1800 {Kamiya K-Assay} (28572)

Instrumentation Laboratory ILAB 600

{Kamiya K-Assay} (28571)

Instrumentation Laboratory ILAB 900

{Kamiya K-Assay} (28573)

Olympus AU 1000 {Kamiya K-Assay}

(46328)

Olympus AU 600 {Kamiya K-Assay}

(46326)

Olympus AU 800 {Kamiya K-Assay}

(46327)

Olympus Reply/AU 560 {Kamiya KAssay} (46329)

Roche Diagnostics Cobas FARA

{Kamiya K-Assay} (55663)

Roche Diagnostics Cobas FARA II

{Kamiya K-Assay} (55664)

Roche Diagnostics Cobas INTEGRA

400 (55634)

Roche Diagnostics Cobas INTEGRA

700 (55643)

Roche Diagnostics Cobas Mira

{Kamiya K-Assay} (55654)

Roche Diagnostics Cobas Mira Plus

{Kamiya K-Assay} (55656)

Roche Diagnostics Cobas Mira S

{Kamiya K-Assay} (55655)

Roche Diagnostics Hitachi 704

{Kamiya K-Assay} (55657)

Roche Diagnostics Hitachi 717

{Kamiya K-Assay} (55658)

Roche Diagnostics Hitachi 736

{Kamiya K-Assay} (55665)

Roche Diagnostics Hitachi 747

{Kamiya K-Assay} (55660)

Roche Diagnostics Hitachi 911

{Kamiya K-Assay} (55661)

Roche Diagnostics Hitachi 914

{Kamiya K-Assay} (55659)

Roche Diagnostics Hitachi 917

{Kamiya K-Assay} (55662)

Technicon AXON {Kamiya K-Assay}

(61460)

The Binding Site MININEPH

{MININEPH C4} (61365)

Wako Diagnostics 30R {Kamiya KAssay} (70236)

ANALYTE: Cytomegalovirus Antibodies

(1039)

TEST SYSTEM ASSAY,

EXAMINATION:

Behring OPUS (07793)

25804 Federal Register / Vol. 65, No. 86 / Wednesday, May 3, 2000 / Notices

Behring OPUS Magnum (07794)

Behring OPUS Plus (07795)

Olympus PK7200 {Olympus PK CMV

System} (blood donor screening

only) (46335)

ANALYTE: Epstein-Barr virus

Antibodies (1603)

TEST SYSTEM ASSAY,

EXAMINATION:

Diamedix MAGO Plus {Diamedix

Immunosimplicity (Is)-EBNA–1

IgM} (13575)

Diamedix MAGO Plus {Diamedix

Immunosimplicity (Is)-EBV–EA–D

IgG} (13563)

Diamedix MAGO Plus {Diamedix

Immunosimplicity (Is)-EBV–EA–D

IgM} (13577)

Diamedix MAGO Plus {Diamedix

Immunosimplicity (Is)-EBV–VCA

IgM} (13579)

ANALYTE: Febrile Agglutinins (1901)

TEST SYSTEM ASSAY,

EXAMINATION:

Germaine Laboratories Febrile

Antigens (slide test) (22273)

Germaine Laboratories Febrile

Antigens (tube test) (22274)

ANALYTE: Helicobacter pylori

Antibodies (2513)

TEST SYSTEM ASSAY,

EXAMINATION:

Diamedix MAGO Plus {Diamedix

Immunosimplicity (Is)–H. pylori

IgG} (13582)

LifeSign Status H. pylori (serum/

plasma) (37153)

ANALYTE: Herpes simplex I and/or II

Antibodies (2530)

TEST SYSTEM, ASSAY,

EXAMINATION:

Sigma Diagnostics APTUS {Herpes-1

IgG} (58556)

Sigma Diagnostics APTUS {Herpes-2

IgG} (58557)

ANALYTE: Immunoglobulins IgA

(2803)

TEST SYSTEM, ASSAY,

EXAMINATION:

Abbott Aeroset (04798)

Bayer ADVIA IMS (08254)

Dade Behring Dimension AR (13517)

Dade Behring Dimension RxL (13519)

Roche Diagnostics Cobas INTEGRA

400 (55634)

Roche Diagnostics Cobas INTEGRA

700 (55643)

The Binding Site MININEPH

{MININEPH IgA} (61362)

ANALYTE: Immunoglobulins IgE (2805)

TEST SYSTEM, ASSAY,

EXAMINATION:

Behring Nephelometer (07273)

Behring Nephelometer II (07563)

Hycor HY–TEC Automated EIA

System {Total IgE EIA} (25313)

TOSOH AIA–600 II (61464)

ANALYTE: Immunoglobulins IgG (2806)

TEST SYSTEM, ASSAY,

EXAMINATION:

Abbott Aeroset (04798)

Bayer ADVIA IMS (08254)

Dade Behring Dimension AR (13517)

Dade Behring Dimension RxL (13519)

Roche Diagnostics Cobas INTEGRA

400 (55634)

Roche Diagnostics Cobas INTEGRA

700 (55643)

The Binding Site MININEPH

{MININEPH IgG} (61471)

ANALYTE: Immunoglobulins IgG

subclasses (2807)

TEST SYSTEM, ASSAY,

EXAMINATION:

The Binding Site MININEPH

{MININEPH IgG1} (61467)

The Binding Site MININEPH

{MININEPH IgG2} (61468)

The Binding Site MININEPH

{MININEPH IgG3} (61470)

The Binding Site MININEPH

{MININEPH IgG4} (61469)

ANALYTE: Immunoglobulins IgM

(2808)

TEST SYSTEM, ASSAY,

EXAMINATION:

Abbott Aeroset (04798)

Bayer ADVIA IMS (08254)

Dade Behring Dimension AR (13517)

Dade Behring Dimension RxL (13519)

Roche Diagnostics Cobas INTEGRA

400 (55634)

Roche Diagnostics Cobas INTEGRA

700 (55643)

The Binding Site MININEPH

{MININEPH IgM} (61363)

ANALYTE: Infectious Mononucleosis

Antibodies (Mono) (2809)

TEST SYSTEM, ASSAY,

EXAMINATION:

Meridian Diagnostics ImmunoCard

STAT! Mono (serum/plasma)

(40334)

Oxoid DrySpot IM Test (46323)

ANALYTE: Lyme Disease Antibodies

(Borrelia burgdorferi Abs) (3714)

TEST SYSTEM, ASSAY,

EXAMINATION:

Diamedix MAGO Plus {Diamedix

Immunosimplicity (Is)-anti-Borrelia

burgdorferi IgG/IgM} (13573)

Diamedix MAGO Plus {Diamedix

Immunosimplicity (Is)-anti-Borrelia

burgdorferi IgM} (13571)

ANALYTE: Mumps Antibodies (4007)

TEST SYSTEM, ASSAY,

EXAMINATION:

Diamedix MAGO Plus {Diamedix

Immunosimplicity (Is)-Mumps IgG}

(13581)

ANALYTE: Mycoplasma pneumoniae

Antibodies (4016)

TEST SYSTEM, ASSAY,

EXAMINATION:

Sigma Diagnostics APTUS

{Mycoplasma IgG} (58570)

ANALYTE: Rheumatoid Factor (RF)

(5508)

TEST SYSTEM, ASSAY,

EXAMINATION:

Abbott Aeroset (04798)

Hycor HY–TEC Automated EIA

System {IgG Rheumatoid Factor}

(25309)

Roche Diagnostics Cobas INTEGRA

700 (55643)

ANALYTE: Rubella Antibodies (5510)

TEST SYSTEM, ASSAY,

EXAMINATION:

Behring OPUS Magnum (07794)

Behring OPUS Plus (07795)

Sigma Diagnostics APTUS {Rubella

IgG} (58563)

ANALYTE: Stem Cells, CD34 (5845)

TEST SYSTEM, ASSAY,

EXAMINATION:

Biometric Imaging IMAGN 2000

{STELLer CD34 Assay} (08188)

ANALYTE: Toxoplasma gondii

Antibodies (6113)

TEST SYSTEM, ASSAY,

EXAMINATION:

Behring OPUS Magnum (07794)

Behring OPUS Plus (07795)

Eiken Toxotest-MT Eiken (16070)

ANALYTE: Treponema pallidum

Antibodies (includes Reagin) (6115)

TEST SYSTEM, ASSAY,

EXAMINATION:

DiaSorin Copalis One ImmunoAssay

System {Treponemal Antigen Total

Ab} (13567)

Olympus PK7200 {Olympus PK TP

System} (blood donor screening

only) (46334)

SPECIALITY/SUBSPECIALITY:

Hematology

ANALYTE: Activated Clotting Time

(ACT) (0461)

TEST SYSTEM, ASSAY,

EXAMINATION:

ITC HEMOCHRON Response (28578)

ANALYTE: Activated Partial

Thromboplastin Time (APTT)

(0409)

TEST SYSTEM, ASSAY,

EXAMINATION:

American Bioproducts STA–R

Analyzer (04875)

Federal Register / Vol. 65, No. 86 / Wednesday, May 3, 2000 / Notices 25805

Dade Behring BFT II (13594)

Dade Behring Coagulation System

(BCS) (13608)

ITC HEMOCHRON Response (28578)

Pacific Hemostasis ThromboScreen

400C (49231)

Sysmex CA–1000 (58604)

Sysmex CA–5000 (58605)

Sysmex CA–6000 (58606)

ANALYTE: Activated Protein C (APC)

Resistance (0526)

TEST SYSTEM, ASSAY,

EXAMINATION:

Pacific Hemostasis ThromboScreen

400C (49231)

ANALYTE: Antithrombin III (ATIII)

(0456)

TEST SYSTEM, ASSAY,

EXAMINATION:

Dade Behring Coagulation System

(BCS) (13608)

Roche Diagnostics Cobas INTEGRA

700 (55643)

ANALYTE: D-dimer (1320)

TEST SYSTEM, ASSAY,

EXAMINATION:

American Bioproducts STA–R

Analyzer {STA-Liatest D-di}

(04876)

ANALYTE: Erythrocyte Sedimentation

Rate (non-waived proced) (1613)

TEST SYSTEM, ASSAY,

EXAMINATION:

AI AnalysInstrument AB ESR–100

(04879)

Polymedco SEDIPLAST ESR {Sedimat

Reader} (49220)

ANALYTE: Fibrinogen (1905)

TEST SYSTEM, ASSAY,

EXAMINATION:

American Bioproducts STA–R

Analyzer (04875)

Beckman Synchron CX4 {Kamiya KAssay} (08245)

Beckman Synchron CX5 {Kamiya KAssay} (08246)

Beckman Synchron CX7 {Kamiya KAssay} (08247)

Dade Behring BFT II (13594)

Dade Behring Coagulation System

(BCS) (13608)

ITC HEMOCHRON Response (28578)

Instrumentation Laboratory ILAB

1800 {Kamiya K-Assay} (28572)

Instrumentation Laboratory ILAB 600

{Kamiya K-Assay} (28571)

Instrumentation Laboratory ILAB 900

{Kamiya K-Assay} (28573)

Olympus AU 1000 {Kamiya K-Assay}

(46328)

Olympus AU 600 {Kamiya K-Assay}

(46326)

Olympus AU 800 {Kamiya K-Assay}

(46327)

Olympus Reply/AU 560 {Kamiya KAssay} (46329)

Pacific Hemostasis ThromboScreen

400C (49231)

Roche Diagnostics Cobas FARA

{Kamiya K-Assay} (55663)

Roche Diagnostics Cobas FARA II

{Kamiya K-Assay} (55664)

Roche Diagnostics Cobas Mira

{Kamiya K-Assay} (55654)

Roche Diagnostics Cobas Mira Plus

{Kamiya K-Assay} (55656)

Roche Diagnostics Cobas Mira S

{Kamiya K-Assay} (55655)

Roche Diagnostics Hitachi 704

{Kamiya K-Assay} (55657)

Roche Diagnostics Hitachi 717

{Kamiya K-Assay} (55658)

Roche Diagnostics Hitachi 747

{Kamiya K-Assay} (55660)

Roche Diagnostics Hitachi 911

{Kamiya K-Assay} (55661)

Roche Diagnostics Hitachi 914

{Kamiya K-Assay} (55659)

Roche Diagnostics Hitachi 917

{Kamiya K-Assay} (55662)

Sysmex CA–1000 (58604)

Sysmex CA–5000 (58605)

Sysmex CA–6000 (58606)

Wako Diagnostics 30R {Kamiya KAssay} (70236)

ANALYTE: Hematocrit (2514)

TEST SYSTEM, ASSAY,

EXAMINATION:

ABX Diagnostics PENTRA 60 (04877)

Bayer ADVIA 60 (08224)

Becton Dickinson QBC STAR (08233)

Instrumentation Laboratory GEM

Premier 3000 (28583)

Nova Stat Profile M7 (43129)

Sysmex XE–2100 (58589)

ANALYTE: Hemoglobin (2515)

TEST SYSTEM, ASSAY,

EXAMINATION:

ABX Diagnostics PENTRA 60 (04877)

Bayer ADVIA 60 (08224)

Becton Dickinson QBC STAR (08233)

Nova Stat Profile M7 (43129)

Radiometer ABL NPT7 Series

Analyzers (55645)

Sysmex XE–2100 (58589)

ANALYTE: Heparin Dose Response

(HDR) (2539)

TEST SYSTEM, ASSAY,

EXAMINATION:

ITC HEMOCHRON Response

(automated dosage calculations)

(28602)

ANALYTE: Heparin Management Panel

(HMP) (2578)

TEST SYSTEM, ASSAY,

EXAMINATION:

Cardiovascular Diagnostics

Rapidpoint Accent System

{Rapidpoint Analyzer/HMT/HTT/

PRT} (10501)

ANALYTE: Platelet Count (4908)

TEST SYSTEM, ASSAY,

EXAMINATION:

ABX Diagnostics PENTRA 60 (04877)

Abbott CELL–DYN 4000 {ImmunoPlt

(CD61) Assay} (04873)

Bayer ADVIA 60 (08224)

Becton Dickinson QBC STAR (08233)

Sysmex R–3500 (58586)

Sysmex XE–2100 (58589)

ANALYTE: Platelet Glycoprotein IIb/IIIa

Receptor Blockade (4989)

TEST SYSTEM, ASSAY,

EXAMINATION:

Accumetrics Ultegra System {Rapid

Platelet Function Assay} (04871)

ANALYTE: Prothrombin Time (PT)

(4922)

TEST SYSTEM, ASSAY,

EXAMINATION:

American Bioproducts STA–R

Analyzer (04875)

Dade Behring BFT II (13594)

Dade Behring Coagulation System

(BCS) (13608)

ITC HEMOCHRON Response (28578)

Pacific Hemostasis ThromboScreen

400C (49231)

Sysmex CA–1000 (58604)

Sysmex CA–5000 (58605)

Sysmex CA–6000 (58606)

ANALYTE: Red Blood Cell Count

(Erythrocyte Count) (RBC) (5502)

TEST SYSTEM, ASSAY,

EXAMINATION:

ABX Diagnostics PENTRA 60 (04877)

Bayer ADVIA 60 (08224)

Sysmex R–3500 (58586)

Sysmex XE–2100 (58589)

ANALYTE: Red Blood Cells, Nucleated

(5526)

TEST SYSTEM, ASSAY,

EXAMINATION:

Applied Imaging WINSCAN (04889)

Sysmex XE–2100 (58589)

ANALYTE: Reptilase Time (5521)

TEST SYSTEM, ASSAY,

EXAMINATION:

Dade Behring Coagulation System

(BCS) (13608)

Dade Behring Sysmex CA–500 Series

(13548)

Pacific Hemostasis ThromboScreen

400C (49231)

Sysmex CA–6000 (58606)

TOA Medical Electronics CA–6000

(61283)

ANALYTE: Reticulocyte Count (5506)

TEST SYSTEM, ASSAY,

EXAMINATION:

Coulter EPICS XL System {ReticONE

25806 Federal Register / Vol. 65, No. 86 / Wednesday, May 3, 2000 / Notices

System} (10490)

Sysmex R–3500 (58586)

Sysmex XE–2100 (58589)

ANALYTE: Reticulocyte, Immature

fraction (5525)

TEST SYSTEM, ASSAY,

EXAMINATION:

Sysmex R–3500 (58586)

Sysmex XE–2100 (58589)

ANALYTE: Semen (5822)

TEST SYSTEM, ASSAY,

EXAMINATION:

Embryotech Laboratories FertilMARQ

(16195)

ANALYTE: Thrombin Time (6105)

TEST SYSTEM, ASSAY,

EXAMINATION:

American Bioproducts STA–R

Analyzer (04875)

Dade Behring Coagulation System

(BCS) (13608)

ITC HEMOCHRON Response (28578)

ITC HEMOCHRON Response

{HEMOCHRON HNTT} (28579)

ITC HEMOCHRON Response

{HEMOCHRON HiTT} (28580)

Pacific Hemostasis ThromboScreen

400C (49231)

Sysmex CA–1000 (58604)

Sysmex CA–5000 (58605)

Sysmex CA–6000 (58606)

ANALYTE: White Blood Cell Count

(Leukocyte Count) (WBC) (7002)

TEST SYSTEM, ASSAY,

EXAMINATION:

ABX Diagnostics PENTRA 60 (04877)

Bayer ADVIA 60 (08224)

Becton Dickinson QBC STAR (08233)

Sysmex XE–2100 (58589)

ANALYTE: White Blood Cell

Differential (WBC Diff) (7001)

TEST SYSTEM, ASSAY,

EXAMINATION:

ABX Diagnostics PENTRA 60 (04877)

Bayer ADVIA 60 (08224)

Becton Dickinson QBC STAR (08233)

Sysmex XE–2100 (58589)

ANALYTE: von Willebrand Factor

(6708)

TEST SYSTEM, ASSAY,

EXAMINATION:

Instrumentation Laboratory IL ACL

6000 (28454)

Instrumentation Laboratory IL ACL

7000 (28487)

Instrumentation Laboratory IL ACL

Futura System (28395)

SPECIALITY/SUBSPECIALITY:

Immunohematology

ANALYTE: ABO group—RBC (0402)

TEST SYSTEM, ASSAY,

EXAMINATION:

Dominion Biologicals NOVACLONE

Anti-A, -B, -A+B (slide, tube)

(13291)

SPECIALITY/SUBSPECIALITY:

Mycology

ANALYTE: Yeast, Candida only (7603)

TEST SYSTEM, ASSAY,

EXAMINATION:

Biomed Diagnostics InTray COLOREX

YEAST (08230)

SPECIALITY/SUBSPECIALITY:

Toxicology / TDM

ANALYTE: Acetaminophen (0406)

TEST SYSTEM, ASSAY,

EXAMINATION:

Roche Diagnostics Cobas INTEGRA

400 (55634)

Roche Diagnostics Cobas INTEGRA

700 (55643)

ANALYTE: Amikacin (0425)

TEST SYSTEM, ASSAY,

EXAMINATION:

Roche Diagnostics Cobas INTEGRA

400 (55634)

Roche Diagnostics Cobas INTEGRA

700 (55643)

ANALYTE: Amphetamines (0428)

TEST SYSTEM, ASSAY,

EXAMINATION:

American BioMedica Rapid Drug

Screen 9 Panel (04870)

LifeSign Status DS THC/OPI/COC/

AMP/BZO/BAR/TCA/PCP (37154)

Phamatech QuickScreen Pro Multi

Drug Screening Test (Model 9177)

(49222)

Phamatech QuickScreen Pro Multi

Drug Screening Test (Model 9178)

(49221)

Princeton BioMeditech AccuSign

DOA 8 THC/OPI/COC/AMP/BZO/

BAR/TCA/PCP (49217)

Roche Diagnostics Cobas INTEGRA

400 (55634)

Roche Diagnostics Cobas INTEGRA

700 (55643)

Roche Diagnostics Hitachi 912

(55624)

Roche Diagnostics OnTrak TesTcup-er

(55635)

Syntron Bioresearch QuikStrip

DrugCheck X Multidrug Screening

Device (58587)

ANALYTE: Barbiturates (0701)

TEST SYSTEM, ASSAY,

EXAMINATION:

American BioMedica Rapid Drug

Screen 9 Panel (04870)

LifeSign Status DS THC/OPI/COC/

AMP/BZO/BAR/TCA/PCP (37154)

Princeton BioMeditech AccuSign

DOA 3 BAR/BZO/PCP (49216)

Princeton BioMeditech AccuSign

DOA 8 THC/OPI/COC/AMP/BZO/

BAR/TCA/PCP (49217)

Roche Diagnostics Cobas INTEGRA

400 (55634)

Roche Diagnostics Cobas INTEGRA

700 (55643)

Roche Diagnostics Hitachi 717 {STC

Auto-Lyte} (55638)

Roche Diagnostics Hitachi 912

(55624)

Roche Diagnostics OnTrak TesTcup-er

(55635)

Roche Diagnostics OnTrak TesTstik

for Barbiturates (55636)

Syntron Bioresearch QuikStrip

DrugCheck X Multidrug Screening

Device (58587)

ANALYTE: Benzodiazepines (0702)

TEST SYSTEM, ASSAY,

EXAMINATION:

Abbott AxSYM (04532)

American BioMedica Rapid Drug

Screen 9 Panel (04870)

LifeSign Status DS THC/OPI/COC/

AMP/BZO/BAR/TCA/PCP (37154)

Princeton BioMeditech AccuSign

DOA 3 BAR/BZO/PCP (49216)

Princeton BioMeditech AccuSign

DOA 8 THC/OPI/COC/AMP/BZO/

BAR/TCA/PCP (49217)

Roche Diagnostics Cobas INTEGRA

400 (55634)

Roche Diagnostics Cobas INTEGRA

700 (55643)

Roche Diagnostics Hitachi 717 {STC

Auto-Lyte} (55638)

Roche Diagnostics Hitachi 912

(55624)

Roche Diagnostics OnTrak TesTcup-er

(55635)

Roche Diagnostics OnTrak TesTstik

for Benzodiazepines (55637)

Syntron Bioresearch QuikStrip

DrugCheck X Multidrug Screening

Device (58587)

ANALYTE: Cannabinoids (THC) (1009)

TEST SYSTEM, ASSAY,

EXAMINATION:

Abbott AxSYM (04532)

American BioMedica Rapid Drug

Screen 3-Panel Test for Coc/THC/

Opiates (04885)

American BioMedica Rapid Drug

Screen 9 Panel (04870)

Drug Detection Devices Ltd

DrugScreen Dip Marijuana Test

(13565)

Drug Detection Devices Ltd

SCREENERS Marijuana Test

(13566)

LifeSign Status DS THC/OPI/COC/

AMP/BZO/BAR/TCA/PCP (37154)

LifeSign Status Stik THC/OPI/COC/

AMPor MET (37155)

Phamatech QuickScreen Pro Multi

Drug Screening Test (Model 9177)

(49222)

Federal Register / Vol. 65, No. 86 / Wednesday, May 3, 2000 / Notices 25807

Phamatech QuickScreen Pro Multi

Drug Screening Test (Model 9178)

(49221)

Princeton BioMeditech AccuSign

DOA 3 THC/OPI/COC (49215)

Princeton BioMeditech AccuSign

DOA 8 THC/OPI/COC/AMP/BZO/

BAR/TCA/PCP (49217)

Redwood Biotech Redi-Screen (55633)

Roche Diagnostics Cobas INTEGRA

400 (55634)

Roche Diagnostics Cobas INTEGRA

700 (55643)

Roche Diagnostics Hitachi 912

(55624)

Sun Biomedical Laboratories

Visualine V Coc/Opiates/THC/Met/

PCP (58590)

Syntron Bioresearch QuikStrip

DrugCheck X Multidrug Screening

Device (58587)

ANALYTE: Carbamazepine (1010)

TEST SYSTEM, ASSAY,

EXAMINATION:

Behring OPUS Plus (07795)

Roche Diagnostics Cobas INTEGRA

400 (55634)

Roche Diagnostics Cobas INTEGRA

700 (55643)

ANALYTE: Carboxyhemoglobin (1012)

TEST SYSTEM, ASSAY,

EXAMINATION:

Radiometer ABL NPT7 Series Analyzers

(55645)

ANALYTE: Cocaine Metabolites (1023)

TEST SYSTEM, ASSAY,

EXAMINATION:

American BioMedica Rapid Drug

Screen 3-Panel Test for Coc/THC/

Opiates (04885)

American BioMedica Rapid Drug

Screen 9 Panel (04870)

LifeSign Status DS THC/OPI/COC/

AMP/BZO/BAR/TCA/PCP (37154)

LifeSign Status Stik THC/OPI/COC/

AMPor MET (37155)

Phamatech QuickScreen Pro Multi

Drug Screening Test (Model 9177)

(49222)

Phamatech QuickScreen Pro Multi

Drug Screening Test (Model 9178)

(49221)

Princeton BioMeditech AccuSign

DOA 3 THC/OPI/COC (49215)

Princeton BioMeditech AccuSign

DOA 8 THC/OPI/COC/AMP/BZO/

BAR/TCA/PCP (49217)

Redwood Biotech Redi-Screen (55633)

Redwood Biotech Redi-Test Cocaine

(55630)

Roche Diagnostics Cobas INTEGRA

400 (55634)

Roche Diagnostics Cobas INTEGRA

700 (55643)

Roche Diagnostics Hitachi 717 {STC

Auto-Lyte} (55638)

Roche Diagnostics Hitachi 912

(55624)

Roche Diagnostics OnTrak TesTcup-er

(55635)

Sun Biomedical Laboratories

Visualine V Coc/Opiates/THC/

Metamph/PCP (58590)

Syntron Bioresearch QuikStrip

DrugCheck X Multidrug Screening

Device (58587)

ANALYTE: Digitoxin (1303)

TEST SYSTEM, ASSAY,

EXAMINATION:

Dade Behring Dimension AR (13517)

Dade Behring Dimension RxL (13519)

Roche Diagnostics Cobas INTEGRA

400 (55634)

Roche Diagnostics Cobas INTEGRA

700 (55643)

ANALYTE: Digoxin (1304)

TEST SYSTEM, ASSAY,

EXAMINATION:

Behring OPUS Magnum (07794)

Behring OPUS Plus (07795)

Roche Diagnostics Cobas INTEGRA

400 (55634)

Roche Diagnostics Cobas INTEGRA

700 (55643)

ANALYTE: Ethanol (Alcohol) (1608)

TEST SYSTEM, ASSAY,

EXAMINATION:

Roche Diagnostics Cobas INTEGRA

400 (55634)

Roche Diagnostics Cobas INTEGRA

700 (55643)

ANALYTE: Gentamicin (2202)

TEST SYSTEM, ASSAY,

EXAMINATION:

Behring OPUS Magnum (07794)

Behring OPUS Plus (07795)

Roche Diagnostics Cobas INTEGRA

400 (55634)

Roche Diagnostics Cobas INTEGRA

700 (55643)

ANALYTE: Lidocaine (3710)

TEST SYSTEM, ASSAY,

EXAMINATION:

Roche Diagnostics Cobas INTEGRA

400 (55634)

Roche Diagnostics Cobas INTEGRA

700 (55643)

ANALYTE: Lithium (3712)

TEST SYSTEM, ASSAY,

EXAMINATION:

Roche Diagnostics Cobas INTEGRA

400 (55634)

Roche Diagnostics Cobas INTEGRA 700

(55643)

ANALYTE: Lysergic Acid Diethylamide

(LSD) (3715)

TEST SYSTEM, ASSAY,

EXAMINATION:

Roche Diagnostics Cobas INTEGRA

400 (55634)

Roche Diagnostics Cobas INTEGRA 700

(55643)

ANALYTE: Methadone (4003)

TEST SYSTEM, ASSAY,

EXAMINATION:

Forefront Diagnostics InstaCheck Drug

Screen Methadone (19042)

Roche Diagnostics Cobas INTEGRA

400 (55634)

Roche Diagnostics Cobas INTEGRA

700 (55643)

Roche Diagnostics Hitachi 912

(55624)

ANALYTE: Methamphetamine/

Amphetamine (4036)

TEST SYSTEM, ASSAY,

EXAMINATION:

LifeSign Status Stik THC/OPI/COC/

AMPor MET (37155)

ANALYTE: Methamphetamines (4004)

TEST SYSTEM, ASSAY,

EXAMINATION:

American BioMedica Rapid Drug

Screen 9 Panel (04870)

Phamatech QuickScreen Pro Multi

Drug Screening Test (Model 9178)

(49221)

Redwood Biotech Redi-Screen (55633)

Sun Biomedical Laboratories

Visualine V Coc/Opiates/THC/Met/

PCP (58590)

Syntron Bioresearch QuikStrip

DrugCheck X Multidrug Screening

Device (58587)

ANALYTE: Methaqualone (4005)

TEST SYSTEM, ASSAY,

EXAMINATION:

Roche Diagnostics Cobas INTEGRA

400 (55634)

Roche Diagnostics Cobas INTEGRA

700 (55643)

ANALYTE: Morphine (4020)

TEST SYSTEM, ASSAY,

EXAMINATION:

Forefront Diagnostics InstaCheck Drug

Screen Morphine 2000 (19043)

Roche Diagnostics OnTrak TesTcup-er

(55635)

ANALYTE: N-Acetylprocainamide

(NAPA) (4301)

TEST SYSTEM, ASSAY,

EXAMINATION:

Roche Diagnostics Cobas INTEGRA

400 (55634)

Roche Diagnostics Cobas INTEGRA

700 (55643)

ANALYTE: Opiates (4601)

TEST SYSTEM, ASSAY,

EXAMINATION:

American BioMedica Rapid Drug

Screen 3-Panel Test for Coc/THC/

25808 Federal Register / Vol. 65, No. 86 / Wednesday, May 3, 2000 / Notices

Opiates (04885)

American BioMedica Rapid Drug

Screen 9 Panel (04870)

LifeSign Status DS THC/OPI/COC/

AMP/BZO/BAR/TCA/PCP (37154)

LifeSign Status Stik THC/OPI/COC/

AMPor MET (37155)

Phamatech QuickScreen Pro Multi

Drug Screening Test (Model 9177)

(49222)

Phamatech QuickScreen Pro Multi

Drug Screening Test (Model 9178)

(49221)

Princeton BioMeditech AccuSign

DOA 3 THC/OPI/COC (49215)

Princeton BioMeditech AccuSign

DOA 8 THC/OPI/COC/AMP/BZO/

BAR/TCA/PCP (49217)

Redwood Biotech Redi-Screen (55633)

Redwood Biotech Redi-Test Opiates

(55631)

Roche Diagnostics Cobas INTEGRA

400 (55634)

Roche Diagnostics Cobas INTEGRA

700 (55643)

Sun Biomedical Laboratories

Visualine V Coc/Opiates/THC/Met/

PCP (58590)

Syntron Bioresearch QuikStrip

DrugCheck X Multidrug Screening

Device (58587)

ANALYTE: Phencyclidine (PCP) (4901)

TEST SYSTEM, ASSAY,

EXAMINATION:

American BioMedica Rapid Drug

Screen 9 Panel (04870)

Bionike AQ Phencyclidine (PCP) Test

(08244)

LifeSign Status DS THC/OPI/COC/

AMP/BZO/BAR/TCA/PCP (37154)

Phamatech QuickScreen Pro Multi

Drug Screening Test (Model 9177)

(49222)

Princeton BioMeditech AccuSign

DOA 3 BAR/BZO/PCP (49216)

Princeton BioMeditech AccuSign

DOA 8 THC/OPI/COC/AMP/BZO/

BAR/TCA/PCP (49217)

Redwood Biotech Redi-Screen (55633)

Redwood Biotech Redi-Test PCP

(55632)

Roche Diagnostics Cobas INTEGRA

400 (55634)

Roche Diagnostics Cobas INTEGRA

700 (55643)

Roche Diagnostics Hitachi 717 {STC

Auto-Lyte} (55638)

Roche Diagnostics Hitachi 912

(55624)

Sun Biomedical Laboratories

Visualine V Coc/Opiates/THC/Met/

PCP (58590)

Syntron Bioresearch QuikStrip

DrugCheck X Multidrug Screening

Device (58587)

TCPI One Step Urine Drug of Abuse

Phencyclidine (PCP) (61453)

ANALYTE: Phenobarbital (4902)

TEST SYSTEM, ASSAY,

EXAMINATION:

Bayer ADVIA IMS (08254)

Behring OPUS Magnum (07794)

Behring OPUS Plus (07795)

Roche Diagnostics Cobas INTEGRA

400 (55634)

Roche Diagnostics Cobas INTEGRA

700 (55643)

ANALYTE: Phenytoin (4903)

TEST SYSTEM, ASSAY,

EXAMINATION:

Behring OPUS Magnum (07794)

Behring OPUS Plus (07795)

Roche Diagnostics Cobas INTEGRA

400 (55634)

Roche Diagnostics Cobas INTEGRA

700 (55643)

ANALYTE: Phenytoin, Free (4904)

TEST SYSTEM, ASSAY,

EXAMINATION:

Roche Diagnostics Cobas INTEGRA

400 (55634)

Roche Diagnostics Cobas INTEGRA

700 (55643)

ANALYTE: Primidone (4912)

TEST SYSTEM, ASSAY,

EXAMINATION:

Roche Diagnostics Cobas INTEGRA

400 (55634)

Roche Diagnostics Cobas INTEGRA

700 (55643)

ANALYTE: Procainamide (4913)

TEST SYSTEM, ASSAY,

EXAMINATION:

Roche Diagnostics Cobas INTEGRA

400 (55634)

Roche Diagnostics Cobas INTEGRA

700 (55643)

ANALYTE: Propoxyphene (4917)

TEST SYSTEM, ASSAY,

EXAMINATION:

Roche Diagnostics Cobas INTEGRA

400 (55634)

Roche Diagnostics Cobas INTEGRA

700 (55643)

Roche Diagnostics Hitachi 912

(55624)

ANALYTE: Quinidine (5202)

TEST SYSTEM, ASSAY,

EXAMINATION:

Roche Diagnostics Cobas INTEGRA

400 (55634)

Roche Diagnostics Cobas INTEGRA

700 (55643)

ANALYTE: Salicylates (5801)

TEST SYSTEM, ASSAY,

EXAMINATION:

Roche Diagnostics Cobas INTEGRA

400 (55634)

Roche Diagnostics Cobas INTEGRA

700 (55643)

ANALYTE: Theophylline (6104)

TEST SYSTEM, ASSAY,

EXAMINATION:

Behring OPUS Magnum (07794)

Behring OPUS Plus (07795)

Roche Diagnostics Cobas INTEGRA

400 (55634)

Roche Diagnostics Cobas INTEGRA

700 (55643)

ANALYTE: Tobramycin (6112)

TEST SYSTEM, ASSAY,

EXAMINATION:

Behring OPUS Magnum (07794)

Behring OPUS Plus (07795)

Roche Diagnostics Cobas INTEGRA

400 (55634)

Roche Diagnostics Cobas INTEGRA

700 (55643)

ANALYTE: Tricyclic Antidepressants

(6117)

TEST SYSTEM, ASSAY,

EXAMINATION:

American BioMedica Rapid Drug

Screen 9 Panel (04870)

LifeSign Status DS THC/OPI/COC/

AMP/BZO/BAR/TCA/PCP (37154)

Princeton BioMeditech AccuSign

DOA 8 THC/OPI/COC/AMP/BZO/

BAR/TCA/PCP (49217)

ANALYTE: Valproic Acid (6701)

TEST SYSTEM, ASSAY,

EXAMINATION:

Bayer ADVIA IMS (08254)

Behring OPUS Magnum (07794)

Behring OPUS Plus (07795)

Dade Behring Dimension AR (13517)

Dade Behring Dimension RxL (13519)

Dade Dimension ES (13420)

Dade Dimension XL (13422)

Roche Diagnostics Cobas INTEGRA

400 (55634)

Roche Diagnostics Cobas INTEGRA

700 (55643)

ANALYTE: Valproic Acid, Free (6702)

TEST SYSTEM, ASSAY,

EXAMINATION:

Roche Diagnostics Cobas INTEGRA

400 (55634)

Roche Diagnostics Cobas INTEGRA

700 (55643)

ANALYTE: Vancomycin (6703)

TEST SYSTEM, ASSAY,

EXAMINATION:

Bayer ADVIA IMS (08254)

Roche Diagnostics Cobas INTEGRA

400 (55634)

Roche Diagnostics Cobas INTEGRA

700 (55643)

SPECIALITY/SUBSPECIALITY:

Virology

ANALYTE: Adenovirus (0410)

Federal Register / Vol. 65, No. 86 / Wednesday, May 3, 2000 / Notices 25809

TEST SYSTEM, ASSAY,

EXAMINATION:

SA Scientific SAS Adeno Test (direct

Ag/visual) (58585)

ANALYTE: Influenza A/B (2835)

TEST SYSTEM, ASSAY,

EXAMINATION:

Quidel QuickVue Influenza Test

(52119)

ANALYTE: Rotavirus (5509)

TEST SYSTEM, ASSAY,

EXAMINATION:

SA Scientific SAS Rotavirus Test

(direct Ag/visual) (58583)

COMPLEXITY: HIGH

SPECIALITY/SUBSPECIALITY:

Bacteriology

ANALYTE: Chlamydia (1016)

TEST SYSTEM, ASSAY,

EXAMINATION:

INTRACEL Bartels Chlamydia EIA

(direct Ag/spectrophotometric)

(28586)

INTRACEL Bartels Chlamydiae FA

Monoclonal (including cell culture)

(28587)

INTRACEL Bartels Chlamydiae

Immunoperoxidase (including cell

culture) (28588)

Roche Diagnostics AMPLICOR CT/NG

Test for Chlamydia trachomatis

(55669)

ANALYTE: Clostridium difficile (1022)

TEST SYSTEM, ASSAY,

EXAMINATION:

INTRACEL Bartels C. difficile Toxin

A EIA (28576)

INTRACEL Bartels C. difficile Toxin

A EIA (direct Ag) (28584)

INTRACEL Bartels Cytotoxicity Assay

for C. difficile (direct Ag) (28589)

Meridian Diagnostics Premier Toxins

A & B (direct antigen/

spectrophotometric) (40345)

Meridian Diagnostics Premier Toxins

A & B (direct antigen/visual)

(40344)

ANALYTE: Escherichia coli (1604)

TEST SYSTEM, ASSAY,

EXAMINATION:

Denka Seiken VTEC-RPLA ‘‘SEIKEN’’

(including culture) (13595)

ANALYTE: Haemophilus (2577)

TEST SYSTEM, ASSAY,

EXAMINATION:

Dade Behring MicroScan

MICroSTREP plus (13597)

ANALYTE: Neisseria gonorrhoeae

(4302)

TEST SYSTEM, ASSAY,

EXAMINATION:

Roche Diagnostics COBAS

AMPLICOR Analyzer (55253)

ANALYTE: Staphylococcus (5807)

TEST SYSTEM, ASSAY,

EXAMINATION:

Oxoid DrySpot Staphytect Plus

(including culture) (46322)

ANALYTE: Streptococcus, group A

(5810)

TEST SYSTEM, ASSAY,

EXAMINATION:

LifeSign Streptolex STAT (including

culture) (37152)

ANALYTE: Streptococcus, group B

(5811)

TEST SYSTEM, ASSAY,

EXAMINATION:

LifeSign Streptolex STAT (including

culture) (37152)

ANALYTE: Streptococcus, group C

(5812)

TEST SYSTEM, ASSAY,

EXAMINATION:

LifeSign Streptolex STAT (including

culture) (37152)

ANALYTE: Streptococcus, group F

(5814)

TEST SYSTEM, ASSAY,

EXAMINATION:

LifeSign Streptolex STAT (including

culture) (37152)

ANALYTE: Streptococcus, group G

(5815)

TEST SYSTEM, ASSAY,

EXAMINATION:

LifeSign Streptolex STAT (including

culture) (37152)

SPECIALITY/SUBSPECIALITY:

Endocrinology

ANALYTE: Calcitonin (1041)

TEST SYSTEM, ASSAY,

EXAMINATION:

KMI Diagnostics Calcitonin ELISA

(34115)

ANALYTE: Cortisol, Urine (extraction

procedure) (1095)

TEST SYSTEM, ASSAY,

EXAMINATION:

Nichols Institute Advantage

Chemiluminescence System (43122)

ANALYTE: Thyroid Stimulating

Hormone (TSH) (6106)

TEST SYSTEM, ASSAY,

EXAMINATION:

BioCheck Thyroid Stimulating

Hormone (TSH) EIA (08248)

ANALYTE: Thyroid Stimulating

Hormone—high sens. (TSH–HS)

(6108)

TEST SYSTEM, ASSAY,

EXAMINATION:

BioCheck Sensitive Thyroid

Stimulating Hormone (S–TSH) EIA

(08251)

ANALYTE: Thyroxine (T4) (6109)

TEST SYSTEM, ASSAY,

EXAMINATION:

BioCheck Total Thyroxine (T4) EIA

(08249)

Biotecx Laboratories OptiCoat T4 EIA

(08221)

ANALYTE: Triiodothyronine (T3)

(6119)

TEST SYSTEM, ASSAY,

EXAMINATION:

BioCheck Triiodothyronine (T3) EIA

(08250)

SPECIALITY/SUBSPECIALITY: General

Chemistry

ANALYTE: Alpha-Fetoprotein—

Amniotic Fluid (0484)

TEST SYSTEM, ASSAY,

EXAMINATION:

Beckman ACCESS Immunoassay

System (07914)

ANALYTE: Alpha-Fetoprotein—

Maternal Serum (0423)

TEST SYSTEM, ASSAY,

EXAMINATION:

Beckman ACCESS Immunoassay

System (07914)

ANALYTE: Carbon Dioxide, Isotope 13

(1150)

TEST SYSTEM, ASSAY,

EXAMINATION:

Finnigan BreathMAT Plus Isotope

Ratio Mass Spectrometer

{Metabolic Solutions Ez-HBT

Helicobacter Blood Test} (19054)

ANALYTE: Creatine Kinase Isoenzymes

(CK Isoenzymes) (1052)

TEST SYSTEM, ASSAY,

EXAMINATION:

Sebia HYDRASYS {Hydragel 7/15/30

ISO–CK} (58597)

ANALYTE: Creatine Kinase MB

Fraction (CKMB) (1002)

TEST SYSTEM, ASSAY,

EXAMINATION:

Randox Laboratories CK–MB NACactivated Test Kit (55159)

ANALYTE: Ferritin (1902)

TEST SYSTEM, ASSAY,

EXAMINATION:

BioCheck Ferritin ELISA (08232)

Johnson & Johnson CDL Amerlite

Analyzer (31016)

ANALYTE: Fructosamine (1914)

25810 Federal Register / Vol. 65, No. 86 / Wednesday, May 3, 2000 / Notices

TEST SYSTEM, ASSAY,

EXAMINATION:

Pointe Scientific Fructosamine

(49227)

ANALYTE: Galactose, Total (2223)

TEST SYSTEM, ASSAY,

EXAMINATION:

Quantase Total Galactose (Newborn)

Screening Assay (52120)

ANALYTE: Galactose–1–Phosphate

Uridyl Transferase (2215)

TEST SYSTEM, ASSAY,

EXAMINATION:

Bio-Rad CODA Neonatal GALT

(08255)

ANALYTE: Homocysteine (2574)

TEST SYSTEM, ASSAY,

EXAMINATION:

Bio-Rad CDM System {Bio-Rad

HPLC} (07792)

Drew Scientific DS30 Analyzer {DS30

Hcy Homocysteine Assay} (13593)

ANALYTE: Leucine (3749)

TEST SYSTEM, ASSAY,

EXAMINATION:

Wallac Neonatal Leucine Test Kit

(70237)

ANALYTE: Lipoprotein Fractions (3720)

TEST SYSTEM, ASSAY,

EXAMINATION:

Helena Laboratories REP/REP3

Cholesterol Profile Template-30

(25307)

Helena Laboratories REP/REP3 Vis

Cholesterol (25306)

Sebia HYDRASYS {Hydragel 7/15/30

LIPO} (58603)

Sebia Hydragel -Mini LIPO/LIPO Kit

(manual) (58602)

ANALYTE: Protein Fractions (4920)

TEST SYSTEM, ASSAY,

EXAMINATION:

Sebia HYDRASYS {Hydragel 5

Proteinurie} (58595)

Sebia HYDRASYS {Hydragel 7/15

HR} (58598)

Sebia Hydragel -Mini HR/HR Kit

(manual) (58600)

Sebia Hydragel -Mini HR/HR Urine

Kit (manual) (58601)

Sebia Hydragel Proteinurie Kit

(manual) (58599)

ANALYTE: Thyroglobulin (6124)

TEST SYSTEM, ASSAY,

EXAMINATION:

Kronus OptiQuant Thyroglobulin Kit

(34116)

ANALYTE: Transferrin, carbohydratedeficient (6165)

TEST SYSTEM, ASSAY,

EXAMINATION:

Axis CDT Turbidometric

Immunoassay (04887)

SPECIALITY/SUBSPECIALITY:

General Immunology

ANALYTE: Anti-B2 Glycoprotein I

(apolipoprotein H) (B2 GPI) (0529)

TEST SYSTEM, ASSAY,

EXAMINATION:

Hemagen VIRGO Beta 2 Glycoprotein

I (B2GPI) IgA (25298)

Hemagen VIRGO Beta 2 Glycoprotein

I (B2GPI) IgG (25296)

Hemagen VIRGO Beta 2 Glycoprotein

I (B2GPI) IgM (25297)

Reaads Medical Products IgA AntiBeta 2 Glycoprotein I Semi-quant

Test Kit (55642)

Reaads Medical Products IgG AntiBeta 2 Glycoprotein I Semi-quant

Test Kit (55640)

Reaads Medical Products IgM Anti-Beta

2 Glycoprotein I Semi-quant Test

Kit (55641)

ANALYTE: Anti-Cardiolipin Antibodies

(0434)

TEST SYSTEM, ASSAY,

EXAMINATION:

Cogent Diagnostics AUTOSTAT II

Anti-Cardiolipin IgG (10497)

Cogent Diagnostics AUTOSTAT II

Anti-Cardiolipin IgM (10496)

ANALYTE: Anti-Centromere Antibodies

(0487)

TEST SYSTEM, ASSAY,

EXAMINATION:

Pharmacia & Upjohn Varelisa

ReCombi ANA Profile (dsDNA,

RNP, Sm, SS–A/Ro, SS–B/La, Scl70, Centromere, Jo-1) (49229)

ANALYTE: Anti-DNA Antibodies (0435)

TEST SYSTEM, ASSAY,

EXAMINATION:

Pharmacia & Upjohn Varelisa

ReCombi ANA Profile (dsDNA,

RNP, Sm,SS–A/Ro, SS–B/La, Scl70, Centromere, Jo-1) (49229)

Stellar Bio Systems Indirect

Fluorescence Assay for Anti-native

DNA IgG (58593)

The Binding Site BINDAZYME AntidsDNA EIA (61461)

ANALYTE: Anti-Endomysial Antibodies

(EMA) (0497)

TEST SYSTEM, ASSAY,

EXAMINATION:

MeDiCa AEmA Test Kit (40335)

ANALYTE: Anti-Gliadin Antibodies

(0528)

TEST SYSTEM, ASSAY,

EXAMINATION:

Cogent Diagnostics AUTOSTAT II

Anti-Gliadin IgA (10492)

Cogent Diagnostics AUTOSTAT II

Anti-Gliadin IgG (10489)

ANALYTE: Anti-Glomerular Basement

Membrane (GBM) Antibodies (0524)

TEST SYSTEM, ASSAY,

EXAMINATION:

Cogent Diagnostics AUTOSTAT II

Anti-GBM (10486)

Hycor HY–TEC Anti-GBM ELISA

(manual) (25302)

ANALYTE: Anti-Jo-1 (0438)

TEST SYSTEM, ASSAY,

EXAMINATION:

Pharmacia & Upjohn Varelisa

ReCombi ANA Profile (dsDNA,

RNP, Sm, SS–A/Ro, SS–B/La, Scl70, Centromere, Jo-1) (49229)

Trinity Biotech Captia ENA Profile

ELISA (Sm, Sm/RNP, SSA/Ro, SSB/

La, Scl-70, Jo-1) (61462)

ANALYTE: Anti-Myeloperoxidase

(MPO) Antibodies (0505)

TEST SYSTEM, ASSAY,

EXAMINATION:

Diamedix Immunosimplicity (Is)–

MPO (P–ANCA) IgG (manual/

qualitative) (13587)

Diamedix Immunosimplicity (Is)–

MPO (P–ANCA) IgG (manual/semiquantitative) (13588)

ANALYTE: Anti-Nuclear Antibodies

(ANA) (0441)

TEST SYSTEM, ASSAY,

EXAMINATION:

Pharmacia & Upjohn Varelisa

ReCombi ANA Screen (dsDNA,

RNP, Sm, SS–A/Ro, SS–B/La, Scl70, Centromere, Jo-1) (49228)

RhiGene ANA ELISA TEST SYSTEM

(55670)

Stellar Bio Systems Indirect

Fluorescence Assay for IgG ANA

HEp2 (58592)

ANALYTE: Anti-Parietal Cell

Antibodies (0442)

TEST SYSTEM, ASSAY,

EXAMINATION:

Cogent Diagnostics AUTOSTAT II

Anti-GPC (10487)

Hycor HY–TEC Anti-GPC ELISA

(manual) (25300)

ANALYTE: Anti-Proteinase-3 (PR–3)

Antibodies (0525)

TEST SYSTEM, ASSAY,

EXAMINATION:

Diamedix Immunosimplicity (Is)-antiPR–3 (C–ANCA) IgG (manual/

qualitative) (13584)

Diamedix Immunosimplicity (Is)-antiPR–3 (C–ANCA) IgG (manual/semiquantitative) (13585)

ANALYTE: Anti-RNP

(Ribonucleoprotein) (0443)

TEST SYSTEM, ASSAY,

EXAMINATION:

Pharmacia & Upjohn Varelisa RNP

Federal Register / Vol. 65, No. 86 / Wednesday, May 3, 2000 / Notices 25811

Antibodies EIA (qualitative) (49223)

Pharmacia & Upjohn Varelisa RNP

Antibodies EIA (semi-quantitative)

(49224)

Pharmacia & Upjohn Varelisa

ReCombi ANA Profile

(dsDNA,RNP,Sm,SS-A/Ro,SS-B/

La,Scl-70,Centromere,Jo-1) (49229)

ANALYTE: Anti-RNP-Sm Antibodies

(0502)

TEST SYSTEM, ASSAY,

EXAMINATION:

Micro Detect MDI Sm/RNP Test

(40340)

Trinity Biotech Captia ENA Profile

ELISA (Sm,Sm/RNP,SSA/Ro,SSB/

La,Scl-70,Jo-1) (61462)

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

TEST SYSTEM, ASSAY,

EXAMINATION:

Micro Detect MDI SS-A Test (40339)

Pharmacia & Upjohn Varelisa

ReCombi ANA Profile (dsDNA,

RNP, Sm, SS–A/Ro, SS–B/La, Scl70,Centromere,Jo-1) (49229)

Trinity Biotech Captia ENA Profile

ELISA (Sm, Sm/RNP, SSA/Ro, SSB/

La, Scl-70, Jo-1) (61462)

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

TEST SYSTEM, ASSAY,

EXAMINATION:

Micro Detect MDI SS-B Test (40343)

Pharmacia & Upjohn Varelisa

ReCombi ANA Profile (dsDNA,

RNP, Sm, SS–A/Ro, SS–B/La, Scl70, Centromere, Jo-1) (49229)

Trinity Biotech Captia ENA Profile

ELISA (Sm, Sm/RNP, SSA/Ro, SSB/

La, Scl-70, Jo-1) (61462)

ANALYTE: Anti–Scl–70 (0448)

TEST SYSTEM, ASSAY,

EXAMINATION:

Pharmacia & Upjohn Varelisa

ReCombi ANA Profile (dsDNA,

RNP, Sm, SS–A/Ro, SS–B/La, Scl70, Centromere, Jo-1) (49229)

Trinity Biotech Captia ENA Profile

ELISA (Sm, Sm/RNP, SSA/Ro, SSB/

La, Scl-70, Jo-1) (61462)

ANALYTE: Anti-Sm (Smith) (0450)

TEST SYSTEM, ASSAY,

EXAMINATION:

Micro Detect MDI Sm Test (40341)

Pharmacia & Upjohn Varelisa

ReCombi ANA Profile (dsDNA,

RNP, Sm, SS–A/Ro, SS–B/La, Scl70, Centromere, Jo-1) (49229)

Trinity Biotech Captia ENA Profile

ELISA (Sm, Sm/RNP, SSA/Ro, SSB/

La, Scl-70, Jo-1) (61462)

ANALYTE: Anti-Thyroglobulin

Antibodies (0453)

TEST SYSTEM, ASSAY,

EXAMINATION:

BRAHMS Diagnostica DYNOtest AntiTg (08243)

Diamedix Immunosimplicity (Is)-antiTG IgG (manual/qualitative) (13591)

Diamedix Immunosimplicity (Is)-antiTG IgG (manual/quantitative)

(13592)

ANALYTE: Anti-Thyroid Peroxidase

(TPO) Antibodies (0527)

TEST SYSTEM, ASSAY,

EXAMINATION:

BRAHMS Diagnostica DYNOtest AntiTPO (08242)

Pharmacia & Upjohn Varelisa TPO

Antibodies EIA (qualitative) (49225)

Pharmacia & Upjohn Varelisa TPO

Antibodies EIA (quantitative)

(49226)

ANALYTE: Anti-Tissue

Transglutaminase (tTG) (0546)

TEST SYSTEM, ASSAY,

EXAMINATION:

IMMCO Diagnostics ImmuLisa AntiTissue Transglutaminase (tTG) Ab

ELISA (qualitative) (28569)

IMMCO Diagnostics ImmuLisa AntiTissue Transglutaminase (tTG) Ab

ELISA (semi-quantitative) (28570)

The Binding Site BINDAZYME AntiTransglutaminase IgA EIA (61463)

ANALYTE: Cerebrospinal Fluid Protein

Fractions (1057)

TEST SYSTEM, ASSAY,

EXAMINATION:

Sebia HYDRASYS {Hydragel 6 CSF}

(58596)

Sebia HYDRASYS {Hydragel 7/15

HR} (58598)

Sebia Hydragel -Mini HR/HR Kit

(manual) (58600)

ANALYTE: Complement, Total (1046)

TEST SYSTEM, ASSAY,

EXAMINATION:

The Binding Site Total Haemolytic

Complement Kit (61450)

ANALYTE: Epstein-Barr virus

Antibodies (1603)

TEST SYSTEM, ASSAY,

EXAMINATION:

Diamedix Immunosimplicity (Is)–

EBNA–1 IgM (manual) (13574)

Diamedix Immunosimplicity (Is)–

EBV–EA–D IgG (manual) (13564)

Diamedix Immunosimplicity (Is)–

EBV–EA–D IgM (manual) (13576)

Diamedix Immunosimplicity (Is)–

EBV–VCA IgM (manual) (13578)

GenBio ImmunoWELL EBNA IgG

Quantitative Test (22254)

GenBio ImmunoWELL EBV VCA IgG

Quantitative Test (22255)

GenBio ImmunoWELL EBV VCA IgM

Quantitative Test (22256)

Quest International SeraQuest EB NA

IgG (qualitative) (52117)

Quest International SeraQuest EB NA

IgG (semi-quantitative) (52118)

Quest International SeraQuest EB

VCA IgG (qualitative) (52115)

Quest International SeraQuest EB

VCA IgG (semi-quantitative) (52116)

Quest International SeraQuest EB

VCA IgM (52114)

ANALYTE: HLA–DR (2576)

TEST SYSTEM, ASSAY,

EXAMINATION:

bioMerieux Vitek HLA–DR oligodetection Kit (08253)

ANALYTE: Helicobacter pylori

Antibodies (2513)

TEST SYSTEM, ASSAY,

EXAMINATION:

Diamedix Immunosimplicity (Is)–H.

pylori IgG (manual) (13583)

ANALYTE: Immunoglobulins IgE (2805)

TEST SYSTEM, ASSAY,

EXAMINATION:

BioCheck Immunoglobulin E (IgE)

ELISA (08231)

Hycor Total IgE RIA (25315)

ANALYTE: Legionella pneumophilia

Serogroup 1 Antigen (3778)

TEST SYSTEM, ASSAY,

EXAMINATION:

INTRACEL Bartels Legionella Urinary

Antigen ELISA (direct Ag/

spectrophotometric) (28575)

INTRACEL Bartels Legionella Urinary

Antigen ELISA (direct Ag/visual)

(28574)

ANALYTE: Lyme Disease Antibodies

(Borrelia burgdorferi Abs) (3714)

TEST SYSTEM, ASSAY,

EXAMINATION:

Diamedix Immunosimplicity (Is)-antiBorrelia burgdorferi IgG/IgM

(manual) (13572)

Diamedix Immunosimplicity (Is)-antiBorrelia burgdorferi IgM (manual)

(13570)

ANALYTE: Lymphocytes, CD19 (3759)

TEST SYSTEM, ASSAY,

EXAMINATION:

Coulter EPICS XL/tetraONE System

{CD45–FITC/CD4–RD1/CD8–ECD/

CD3–PC5&CD45–FITC/CD56–RD1/

CD19–ECD/CD3–PC5} (CYTO–

STAT tetraCHROME) (10495)

ANALYTE: Lymphocytes, CD3 (3760)

TEST SYSTEM, ASSAY,

EXAMINATION:

Coulter EPICS XL/tetraONE System

{CD45–FITC/CD4–RD1/CD8–ECD/

CD3–PC5&CD45–FITC/CD56–RD1/

CD19–ECD/CD3–PC5} (CYTO–

STAT tetraCHROME) (10495)

ANALYTE: Lymphocytes, CD3–/CD56+

(3783)

25812 Federal Register / Vol. 65, No. 86 / Wednesday, May 3, 2000 / Notices

TEST SYSTEM, ASSAY,

EXAMINATION:

Coulter EPICS XL/tetraONE System

{CD45–FITC/CD4–RD1/CD8–ECD/

CD3–PC5&CD45–FITC/CD56–RD1/

CD19–ECD/CD3–PC5} (CYTO–

STAT tetraCHROME) (10495)

ANALYTE: Lymphocytes, CD3/CD4

(3766)

TEST SYSTEM, ASSAY,

EXAMINATION:

Coulter EPICS XL/tetraONE System

{CD45–FITC/CD4–RD1/CD8–ECD/

CD3–PC5&CD45–FITC/CD56–RD1/

CD19–ECD/CD3–PC5} (CYTO–

STAT tetraCHROME) (10495)

ANALYTE: Lymphocytes, CD3/CD8

(3767)

TEST SYSTEM, ASSAY,

EXAMINATION:

Coulter EPICS XL/tetraONE System

{CD45–FITC/CD4–RD1/CD8–ECD/

CD3–PC5&CD45–FITC/CD56–RD1/

CD19–ECD/CD3–PC5} (CYTO–

STAT tetraCHROME) (10495)

ANALYTE: Lymphocytes, CD4 (3761)

TEST SYSTEM, ASSAY,

EXAMINATION:

Coulter EPICS XL/tetraONE System

{CD45–FITC/CD4–RD1/CD8–ECD/

CD3–PC5&CD45–FITC/CD56–RD1/

CD19–ECD/CD3–PC5} (CYTO–

STAT tetraCHROME) (10495)

ANALYTE: Lymphocytes, CD8 (3764)

TEST SYSTEM, ASSAY,

EXAMINATION:

Coulter EPICS XL/tetraONE System

{CD45–FITC/CD4–RD1/CD8–ECD/

CD3–PC5&CD45–FITC/CD56–RD1/

CD19–ECD/CD3–PC5} (CYTO–

STAT tetraCHROME) (10495)

ANALYTE: Mumps Antibodies (4007)

TEST SYSTEM, ASSAY,

EXAMINATION:

Diamedix Immunosimplicity (Is)-

Mumps IgG (manual) (13580)

ANALYTE: Rheumatoid Factor (RF)

(5508)

TEST SYSTEM, ASSAY,

EXAMINATION:

Cogent Diagnostics AUTOSTAT II

Rheumatoid Factor IgG (10498)

Micro Detect MDI RF Test (40342)

ANALYTE: Treponema pallidum

Antibodies (includes Reagin) (6115)

TEST SYSTEM, ASSAY,

EXAMINATION:

Avanti Polar Lipids VDRL Antigen

Slide Test (04878)

ANALYTE: Varicella-Zoster Virus

Antibodies (6704)

TEST SYSTEM, ASSAY,

EXAMINATION:

Light Diagnostics SimulFluor HSV/

VZV IFA (direct antigen) (37161)

Light Diagnostics SimulFluor HSV/

VZV IFA (including culture)

(37162)

SPECIALITY/SUBSPECIALITY:

Hematology

ANALYTE: Activated Partial

Thromboplastin Time (APTT)

(0409)

TEST SYSTEM, ASSAY,

EXAMINATION:

Diagnostica Stago PTT–LT Test Kit

(manual) (13312)

ANALYTE: Alpha-2-Antiplasmin (0463)

TEST SYSTEM, ASSAY,

EXAMINATION:

American Bioproducts STA–R

Analyzer (04875)

Biopool Spectrolyse alpha-2-

antiplasmin Kit (07602)

Dade Behring Coagulation System

(BCS) (13608)

Sysmex CA–6000 (58606)

TOA Medical Electronics CA–6000

(61283)

ANALYTE: Antithrombin III (ATIII)

(0456)

TEST SYSTEM, ASSAY,

EXAMINATION:

American Bioproducts STA–R

Analyzer (04875)

Chromogenix COACUTE

Antithrombin R (manual) (10314)

Pacific Hemostasis ThromboScreen

400C (49231)

Sysmex CA–6000 (58606)

ANALYTE: Coagulation Factors (1044)

TEST SYSTEM, ASSAY,

EXAMINATION:

American Bioproducts STA–R

Analyzer (04875)

Dade Behring Coagulation System

(BCS) (13608)

Dade Behring Sysmex CA–500 Series

(13548)

Pacific Hemostasis ThromboScreen

400C (49231)

Sysmex CA–1000 (58604)

Sysmex CA–5000 (58605)

Sysmex CA–6000 (58606)

ANALYTE: Fibrinogen (1905)

TEST SYSTEM, ASSAY,

EXAMINATION:

Pacific Hemostasis ThromboScreen

400C (von Clauss methodology)

(49232)

ANALYTE: Heparin (2518)

TEST SYSTEM, ASSAY,

EXAMINATION:

American Bioproducts STA–R

Analyzer (04875)

Chromogenix COAMATIC Heparin

(manual) (10500)

Dade Behring Coagulation System

(BCS) (13608)

Dade Behring Sysmex CA–500 Series

(13548)

Helena Laboratories Chrom Z-Heparin

(manual) (25238)

Helena Laboratories PACKS–4 (25029)

Pacific Hemostasis ThromboScreen

400C (49231)

Sysmex CA–6000 (58606)

TOA Medical Electronics CA–6000

(61283)

ANALYTE: Heparin Dose Response

(HDR) (2539)

TEST SYSTEM, ASSAY,

EXAMINATION:

ITC HEMOCHRON Response (manual

dosage calculations) (28603)

ANALYTE: Heparin, Low Molecular

Weight (LMWH) (2558)

TEST SYSTEM, ASSAY,

EXAMINATION:

American Bioproducts STA–R

Analyzer (04875)

Helena Laboratories Chrom Z-Heparin

(manual) (25238)

Helena Laboratories PACKS–4 (25029)

ANALYTE: Heparin/Protamine Titration

(HPT) (2538)

TEST SYSTEM, ASSAY,

EXAMINATION:

ITC HEMOCHRON Response (28578)

ANALYTE: Lupus Anticoagulants

(3728)

TEST SYSTEM, ASSAY,

EXAMINATION:

Dade Behring Coagulation System

(BCS) (13608)

Instrumentation Laboratory IL ACL

Futura System {LAC Screen/

Confirm} (28601)

ANALYTE: Plasminogen (4907)

TEST SYSTEM, ASSAY,

EXAMINATION:

American Bioproducts STA–R

Analyzer (04875)

Dade Behring Coagulation System

(BCS) (13608)

Sysmex CA–6000 (58606)

ANALYTE: Protamine Response Test

(PRT) (4945)

TEST SYSTEM, ASSAY,

EXAMINATION:

ITC HEMOCHRON Response (28578)

ANALYTE: Protein C (4929)

TEST SYSTEM, ASSAY,

EXAMINATION:

American Bioproducts STA–R

Analyzer (04875)

Federal Register / Vol. 65, No. 86 / Wednesday, May 3, 2000 / Notices 25813

Dade Behring Coagulation System

(BCS) (13608)

Dade Behring Sysmex CA–500 Series

(13548)

Sysmex CA–6000 (58606)

TOA Medical Electronics CA–6000

(61283)

ANALYTE: Protein S (4930)

TEST SYSTEM, ASSAY,

EXAMINATION:

American Bioproducts STA–R

Analyzer (04875)

Reaads Medical Products Monoclonal

Free Protein S Antigen Test Kit

(55639)

SPECIALITY/SUBSPECIALITY:

Mycobacteriology

ANALYTE: Mycobacteria (4024)

TEST SYSTEM, ASSAY,

EXAMINATION:

Difco ESP Culture System II (13399)

ANALYTE: Mycobacterium tuberculosis

complex (4015)

TEST SYSTEM, ASSAY,

EXAMINATION:

Gen-Probe AMPLIFIED

Mycobacterium Tuberculosis Direct

(MTD) Test (22276)

SPECIALITY/SUBSPECIALITY:

Parasitology

ANALYTE: Pneumocystis (4926)

TEST SYSTEM, ASSAY,

EXAMINATION:

Light Diagnostics Pneumocystis

carinii DFA (37158)

SPECIALITY/SUBSPECIALITY:

Virology

ANALYTE: Adenovirus (0410)

TEST SYSTEM, ASSAY,

EXAMINATION:

INTRACEL Bartels Viral Respiratory

Kit (including cell culture) (28600)

SA Scientific SAS Adeno Test

(including cell culture) (58584)

ANALYTE: Cytomegalovirus (1038)

TEST SYSTEM, ASSAY,

EXAMINATION:

INTRACEL Bartels CINAKIT CMV

Antigenemia (28568)

INTRACEL Bartels CMV Immed. Early

Ag IFA (including cell culture)

(28585)

INTRACEL Bartels Direct CMV DFA

Kit (direct Ag) (28590)

INTRACEL Bartels Direct CMV DFA

Kit (including cell culture) (28591)

Organon Teknika NucliSens CMV

pp67 (46332)

ANALYTE: Herpes simplex (2529)

TEST SYSTEM, ASSAY,

EXAMINATION:

INTRACEL Bartels HSV 1 & 2 FA

Typing (including cell culture)

(28592)

INTRACEL Bartels HSV FA Bivalent

DFA (including cell culture)

(28593)

INTRACEL Bartels HSV

Immunoperoxidase Test (including

cell culture) (28594)

Light Diagnostics SimulFluor HSV

1/2 IFA (direct antigen) (37159)

Light Diagnostics SimulFluor HSV

1/2 IFA (including culture) (37160)

Light Diagnostics SimulFluor HSV/

VZV IFA (direct antigen) (37161)

Light Diagnostics SimulFluor HSV/

VZV IFA (including culture)

(37162)

ANALYTE: Influenza A (2828)

TEST SYSTEM, ASSAY,

EXAMINATION:

INTRACEL Bartels PRIMA Influenza

A EIA (direct Ag/

spectrophotometric) (28595)

INTRACEL Bartels PRIMA Influenza

A EIA (including cell culture)

(28596)

INTRACEL Bartels Viral Respiratory

Kit (direct Ag) (28599)

INTRACEL Bartels Viral Respiratory

Kit (including cell culture) (28600)

ANALYTE: Influenza B (2829)

TEST SYSTEM, ASSAY,

EXAMINATION:

INTRACEL Bartels Viral Respiratory

Kit (direct Ag) (28599)

INTRACEL Bartels Viral Respiratory

Kit (including cell culture) (28600)

ANALYTE: Parainfluenza 1 (4959)

TEST SYSTEM, ASSAY,

EXAMINATION:

INTRACEL Bartels Viral Respiratory

Kit (direct Ag) (28599)

INTRACEL Bartels Viral Respiratory

Kit (including cell culture) (28600)

ANALYTE: Parainfluenza 2 (4960)

TEST SYSTEM, ASSAY,

EXAMINATION:

INTRACEL Bartels Viral Respiratory

Kit (including cell culture) (28600)

ANALYTE: Parainfluenza 3 (4961)

TEST SYSTEM, ASSAY,

EXAMINATION:

INTRACEL Bartels Viral Respiratory

Kit (direct Ag) (28599)

INTRACEL Bartels Viral Respiratory

Kit (including cell culture) (28600)

ANALYTE: Respiratory syncytial virus

(5503)

TEST SYSTEM, ASSAY,

EXAMINATION:

INTRACEL Bartels RSV (FA) Test Kit

(direct Ag) (28597)

INTRACEL Bartels RSV (FA) Test Kit

(including cell culture) (28598)

INTRACEL Bartels Viral Respiratory

Kit (direct Ag) (28599)

INTRACEL Bartels Viral Respiratory

Kit (including cell culture) (28600)

ANALYTE: Rotavirus (5509)

TEST SYSTEM, ASSAY,

EXAMINATION:

Eldan-Tech ROTA-dan Rapid

Rotavirus EIA (direct Ag/

spectrophotometric) (16131)

Eldan-Tech ROTA-dan Rapid

Rotavirus EIA (direct Ag/visual)

(16132)

COMPLEXITY: WAIVED

SPECIALITY/SUBSPECIALITY:

Bacteriology

ANALYTE: Helicobacter pylori (2512)

TEST SYSTEM, ASSAY,

EXAMINATION:

Ballard Medical Products CLOtest

(08223)

ANALYTE: Streptococcus, group A

(5810)

TEST SYSTEM, ASSAY,

EXAMINATION:

Fisher HealthCare Sure-Vue Strep A

(direct from throat swab) (19038)

Remel RIM A.R.C. Strep A Test (direct

from throat swab) (55687)

SPECIALITY/SUBSPECIALITY:

Endocrinology

ANALYTE: Ovulation Test (LH) by

Visual Color Comparison (9461)

TEST SYSTEM, ASSAY,

EXAMINATION:

Germaine Laboratories AimStep

Ovulation (22271)

Unipath ClearPlan Easy Ovulation

Test (64052)

ANALYTE: Urine HCG by Visual Color

Comparison Tests (9642)

TEST SYSTEM, ASSAY,

EXAMINATION:

ACON One Step Home Pregnancy

Test (04881)

ACON hCG Urine One Step

Pregnancy Test Device (04882)

CENOGENICS ACCUNATE-ONE

STEP (10484)

Fisher HealthCare Sure-Vue Serum/

Urine hCG (19041)

Fisher HealthCare Sure-Vue Serum/

Urine hCG–STAT (19040)

Fisher HealthCare Sure-Vue Urine

hCG (19039)

Germaine Laboratories AccuDip

Home Pregnancy Test (22267)

Germaine Laboratories AccuHome

Pregnancy Test (22268)

25814 Federal Register / Vol. 65, No. 86 / Wednesday, May 3, 2000 / Notices

Germaine Laboratories AccuPlus

Home Pregnancy Test (22269)

Germaine Laboratories AimStick

Home Pregnancy Test (22266)

InBios InSure Pregnancy Test (28582)

Remel RIM A.R.C. hCG Pregnancy

Test (55673)

Unipath ClearBlue Easy One Minute

Pregnancy Test (64051)

Unipath ClearPlan Easy Home

Pregnancy Test (64050)

Unipath ClearPlan Easy II Home

Pregnancy Test (64053)

Wampole Clearview EASY HCG

(70235)

SPECIALITY/SUBSPECIALITY: General

Chemistry

ANALYTE: Cholesterol (1020)

TEST SYSTEM, ASSAY,

EXAMINATION:

Polymer Technology Systems MTM

BioScanner 1000 (for OTC use)

(49196)

ANALYTE: Fecal Occult Blood (9191)

TEST SYSTEM, ASSAY,

EXAMINATION:

CENOGENICS TRI–SLIDE and

SINGLE-SLIDE Stool Blood Test

(10483)

Immunostics Colon Alert (28567)

Laboratory Diagnostics QUIK–CULT

(37156)

ANALYTE: Fructosamine (1914)

TEST SYSTEM, ASSAY,

EXAMINATION:

LXN IN CHARGE Diabetes Control

System (37150)

ANALYTE: Glucose Monitoring Devices

(FDA Cleared/Home Use) (9221)

TEST SYSTEM, ASSAY,

EXAMINATION:

Clinical Diagnostics PocketLab II

Blood Glucose Monitoring System

(10482)

Home Diagnostics Prestige LX Blood

Glucose System (25295)

LXN GO System (37157)

LXN IN CHARGE Diabetes Control

System (37150)

MediSense Precision PCx Point of

Care Mgmt System for Blood

Glucose Testing (40332)

TheraSense FreeStyle Blood Glucose

Monitoring System (61451)

ANALYTE: HDL Cholesterol (2550)

TEST SYSTEM, ASSAY,

EXAMINATION:

Polymer Technology Systems

BioScanner (for OTC use) (49233)

ANALYTE: Ketone, Blood (3403)

TEST SYSTEM, ASSAY,

EXAMINATION:

Polymer Technology Systems

BioScanner (for OTC use) (49233)

SPECIALITY/SUBSPECIALITY: General

Immunology

ANALYTE: Helicobacter pylori

Antibodies (2513)

TEST SYSTEM, ASSAY,

EXAMINATION:

Applied Biotech SureStep H. pylori

WB Test (whole blood) (04874)

LifeSign Status H. pylori (for whole

blood) (37151)

ANALYTE: Infectious Mononucleosis

Antibodies (Mono) (2809)

TEST SYSTEM, ASSAY,

EXAMINATION:

Meridian Diagnostics ImmunoCard

STAT! Mono (whole blood) (40333)

Remel RIM A.R.C. Mono Test (whole

blood) (55686)

SPECIALITY/SUBSPECIALITY:

Hematology

ANALYTE: Erythrocyte Sedimentation

Rate,nonautomated waived (9161)

TEST SYSTEM, ASSAY,

EXAMINATION:

Polymedco SEDIPLAST

WESTERGREN ESR (49219)

Polymedco SEDIPLAST WINTROBE

ESR (49218)

SPECIALITY/SUBSPECIALITY:

Urinalysis

ANALYTE: Urine Dipstick or Tablet

Analytes, nonautomated (9641)

TEST SYSTEM, ASSAY,

EXAMINATION:

Germaine Laboratories AimStick 10–

SG (22264)

Germaine Laboratories AimStick US–

2 (22263)

Germaine Laboratories AimStick US–

3 (22262)

Germaine Laboratories AimStick US–

9 (22265)

International Newtech Develop.

Urinalysis Reagent Strip (10

Parameters) (28581)

TCPI URI–TEST Protein in Urine

(61454)

[FR Doc. 00–10876 Filed 5–2–00; 8:45 am]

BILLING CODE 4163–18–P