Radioassay, Triiodothyronine Uptake

FDA product code KHQ · 93 cleared devices

Class 2 Clinical Chemistry

Regulation: 21 CFR 862.1715
Review panel: CH
Implant: No
Life sustaining: No
Third party review: No
GMP exempt: No
Clearance span: 1976-10-29 – 1998-06-10

KHQ 1998-06-10

ACE T UPTAKE REAGENT TU CALIBRATORS

Applicant Schiapparelli Biosystems, Inc.

K number K981375

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KHQ 1998-02-04

T-UPTAKE MICROPLATE EIA

Applicant Monobind

K number K980088

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KHQ 1997-03-24

CHIRON DIAGNOSTICS ACS:180TU P

Applicant Chiron Diagnostics Corp.

K number K970539

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KHQ 1996-11-27

VITROS IMMUNODIAGNOSTICS PRODUCTS T3 UPTAKE REAGENT PACK (GEM.1025) AND T3 UPTAKE CALIBRATORS (GEM.C025)

Applicant Johnson & Johnson Clinical Diagnostics, Inc.

K number K964308

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KHQ 1996-06-12

ELECSYS T-UPTAKE ASSAY

Applicant Boehringer Mannheim Corp.

K number K961488

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KHQ 1995-12-21

CEDIA T UPTAKE ASSAY

Applicant Boehringer Mannheim Corp.

K number K954807

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KHQ 1995-05-15

T-UPTAKE EIA TEST

Applicant Diagnostic Reagents, Inc.

K number K951586

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KHQ 1994-11-22

STRATUS(R) THYROID UPTAKE FLUOR ENZYME IMMUNOASSAY

Applicant Baxter Diagnostics, Inc.

K number K933414

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KHQ 1994-06-21

AXSYM(TM) T-UPTAKE

Applicant Abbott Laboratories

K number K934312

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KHQ 1994-03-22

VIDAS T UPTAKE

Applicant Biomerieux Vitek, Inc.

K number K935816

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KHQ 1993-11-17

T3 UPTAKE CHEMILUMINESCENCE ASSAY

Applicant Nichols Institute Diagnostics

K number K926220

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KHQ 1993-07-22

IQ TUPTAKE ASSAY

Applicant Becton Dickinson Advanced Diagnostics

K number K931294

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KHQ 1993-05-20

COBAS(R)-FP REAGENTS FOR T-UPTAKE/CALIBRATORS

Applicant Roche Diagnostic Systems, Inc.

K number K926443

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KHQ 1992-12-28

CIBA CORNING ACS T UPTAKE IMMUNOASSAY

Applicant Ciba Corning Diagnostics Corp.

K number K925257

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KHQ 1992-10-09

VISTA THYROXINE UPTAKE ASSAY

Applicant Syva Co.

K number K923676

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KHQ 1991-09-30

AIA-PACK T-U

Applicant Tosoh Corp.

K number K913663

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KHQ 1991-09-18

SR1 T3 UPTAKE ENZYME IMMUNOASSAY(MAG SOLID-PHASE)

Applicant Serono-Baker Diagnostics, Inc.

K number K911912

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KHQ 1991-04-29

CIBA CORNING ACS T UPTAKE IMMUNOASSAY

Applicant Ciba Corning Diagnostics Corp.

K number K911093

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KHQ 1990-10-12

IL T UPTAKE ASSAY SYSTEM

Applicant Instrumentation Laboratory CO

K number K903396

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KHQ 1990-08-09

SEROZYME FREE T3 IMMUNOASSAY

Applicant Advanced Magnetics, Inc.

K number K902748

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KHQ 1990-07-30

OPUS TM T-UPTAKE TEST SYSTEM

Applicant Pb Diagnostic Systems, Inc.

K number K902797

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KHQ 1990-01-18

T UPTAKE ENZYME IMMUNOASSAY CRIMPED TUBE KIT

Applicant In Vitro Diagnostics, Inc.

K number K896925

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KHQ 1989-11-08

FIAGEN T3 UPTAKE CATALOGUE #101-402

Applicant Cyberfluor, Inc.

K number K895186

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KHQ 1989-09-05

EMIT T-UPTAKE ASSAY

Applicant Syva Co.

K number K894145

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KHQ 1989-06-16

D-CHEM(TM) T-UPTAKE TEST KIT FOR T-UPTAKE DETERMIN

Applicant Photec Diagnostics, Inc.

K number K892224

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KHQ 1989-04-10

VENTREX COATED TUBE T3 UPTAKE

Applicant Ventrex Laboratories, Inc.

K number K891068

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KHQ 1989-02-17

ACA THYRONINE UPTAKE (TU E) METHOD

Applicant The DU Pont Co.

K number K885259

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KHQ 1988-10-31

TBG 125I RIA KIT, RADIOIMMUNO. OF SERUM THYROXINE

Applicant Biotecx Laboratories, Inc.

K number K883765

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KHQ 1988-09-09

T3 UPTAKE SEROZYME ENZYME IMMUNO KT/MAG SOLID PHAS

Applicant Serono Diagnostics, Inc.

K number K883085

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KHQ 1988-06-10

EMIT CONVENIENCE PACK: T-UPTAKE ASSAY

Applicant Syva Co.

K number K881855

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KHQ 1988-04-18

EMIT T-UPTAKE ASSAY THYROID HORMONE BINDING RATIO

Applicant Syva Co.

K number K880619

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KHQ 1988-02-18

AMERLITE T3U ASSAY LAN.0004/1004/2004, 240/480/144

Applicant Amersham Corp.

K number K874362

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KHQ 1987-08-21

CEDIA(TM) T UPTAKE

Applicant Microgenics Corp.

K number K872447

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KHQ 1987-08-17

IMMUBEAD THYROID UPTAKE

Applicant Immunotech Corp.

K number K872172

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KHQ 1987-07-09

AFFINITY(TM) I UPTAKE IMMUNIT(TM)

Applicant Bd Becton Dickinson Vacutainer Systems Preanalytic

K number K865083

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KHQ 1986-12-16

CIBA CORNING MAGIC(R) LITE TU IMMUNOASSAY

Applicant Ciba Corning Diagnostics Corp.

K number K864132

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KHQ 1986-10-07

PANCOAT T3 UPTAKE COATED TUBE RADIOIMMUNOASSAY KIT

Applicant Pantex, Div. Bio-Analysis, Inc.

K number K862447

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KHQ 1986-09-25

FREE T3 RADIOIMMUNOASSAY KIT

Applicant Bioclinical Group

K number K862968

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KHQ 1986-05-23

MMS T3 UPTAKE

Applicant Micromedic Systems

K number K861262

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KHQ 1986-04-11

STRAT THYROID UPTAKE FLUROMET ENZYME IMMUNOASSAY

Applicant American Dade

K number K860422

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KHQ 1986-02-06

T3 UPTAKE RADIOIMMUNOASSAY KIT

Applicant Cambridge Medical Technology

K number K855169

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KHQ 1986-01-24

T-3 UPTAKE/RIASSAY

Applicant Ria Diagnostics

K number K855033

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KHQ 1984-09-07

TERUMO SENSIBEAD EIA THYROID UPTAKE KIT

Applicant Terumo Medical Corp.

K number K842694

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KHQ 1984-06-25

T3 UPTAKE

Applicant Syncor Intl. Corp.

K number K841927

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KHQ 1984-04-01

IMMPULSE TBC ASSAY REAGENTS

Applicant Paragon Diagnostics, Inc.

K number K840853

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KHQ 1984-03-09

TRI-TUBE RIA

Applicant Nuclear Medical Laboratories, Inc.

K number K840589

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KHQ 1984-03-09

STRATUS THYROID UPTAKE FLUOROMETRIC

Applicant American Dade

K number K834209

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KHQ 1984-01-30

ACA THYROXINE UPTAKE ANALYTICAL TEST

Applicant E.I. Dupont DE Nemours & Co., Inc.

K number K833703

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KHQ 1983-08-11

MAGIC TM 125I T3 UPTAKE RADIOASSAY

Applicant Corning Medical & Scientific

K number K831613

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KHQ 1983-04-18

UPTAKE T3 RADIOIMMUNOASSAY KIT

Applicant Medical & Scientific Designs, Inc.

K number K830900

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KHQ 1983-04-12

TDX T-UPTAKE

Applicant Abbott Laboratories

K number K830912

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KHQ 1982-10-08

ADVANCE TM T-3 UPTAKE ASSAY

Applicant Syva Co.

K number K822592

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KHQ 1982-09-30

T3 UPTAKE KITS

Applicant Pcl-Ria, Inc.

K number K822612

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KHQ 1982-09-30

LEECO T3% DIAGNOSTIC KIT

Applicant Leeco Diagnostics, Inc.

K number K822575

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KHQ 1982-06-25

ZETAPHASE T3 UPTAKE DIAGNOSTIC KIT

Applicant Amf Biological and Diagnostics Co.

K number K821553

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KHQ 1982-06-24

T3 UPTAKE DIAGNOSTIC KIT

Applicant Diagnostic Reagents, Inc.

K number K821722

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KHQ 1982-04-16

ENZYME-TEST TBC T4 UPTAKE

Applicant Icl Scientific

K number K820879

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KHQ 1982-03-04

T3 UPTAKE-SQUIBB DIAGNOSTIC KIT

Applicant E. R. Squibb & Sons, Inc.

K number K820340

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KHQ 1981-04-08

T3 UPTAKE KIT

Applicant Immuno Assay Corp.

K number K810857

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KHQ 1981-03-31

COAT-A-COUNT T3 UPTAKE KIT

Applicant Diagnostic Products Corp.

K number K810717

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KHQ 1981-02-10

DAC-CEL T3 UPTAKE

Applicant Burroughs Wellcome Co.

K number K810212

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KHQ 1981-01-02

IMMU-TRACE T3 UPTAKE (T3U) REAGENTS

Applicant American Dade

K number K803044

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KHQ 1980-10-31

T3 UPTAKE TEST SYSTEM

Applicant American Diagnostic Corp.

K number K802468

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KHQ 1980-10-31

OREAI-Q-TU TEST

Applicant Organon, Inc.

K number K802464

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KHQ 1980-10-23

ANALYTE T3 UPTAKE

Applicant Technicon Instruments Corp.

K number K802246

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KHQ 1980-06-20

A-GENT THYROZYME UPTAKE INHIBITOR ASSAY

Applicant Abbott Laboratories

K number K800911

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KHQ 1980-02-13

EMC-M-180, T3 UPTAKE - 100 TUBES

Applicant Endocrine-Metabolic Center

K number K800188

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KHQ 1980-02-13

AMES RIALYZE - UPTAKE CHROM. TUBES

Applicant Miles Laboratories, Inc.

K number K800170

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KHQ 1980-02-13

VENTRE/SEP T3 UPTAKE RADIOASSAY

Applicant Ventrex Laboratories, Inc.

K number K800165

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KHQ 1980-01-17

AUTOPAK-12 UPTAKE TEST DELIVERY SYSTEM

Applicant Micromedic Systems

K number K792662

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KHQ 1980-01-16

T3 UPTAKE (T3U) REAGENTS

Applicant Dade, Baxter Travenol Diagnostics, Inc.

K number K792607

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KHQ 1979-12-27

TIPSEP-T3U TRIIODOTHYRONINE UPTAKE

Applicant Nuclear Diagnostics, Inc.

K number K792484

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KHQ 1979-09-27

IMMUCHEM COVALENT COAT BINDING

Applicant Immuchem Corp.

K number K791662

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KHQ 1979-08-16

T3 UPTAKE RADIOIMMUNOASSAY KIT

Applicant Technia Diagnostics , Ltd.

K number K791361

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KHQ 1979-05-03

T-3 UPTAKE (MAA) KIT

Applicant Amersham Corp.

K number K790461

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KHQ 1979-04-20

T3 UPTAKE KIT

Applicant E. R. Squibb & Sons, Inc.

K number K790417

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KHQ 1979-01-03

RIA KIT, QUANTITOPE T3 UPTAKE

Applicant Kallestad Laboratories, Inc.

K number K781905

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KHQ 1978-11-08

RIA, T3 UPTAKE SOLID PHASE

Applicant Bd Becton Dickinson Vacutainer Systems Preanalytic

K number K781662

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KHQ 1978-09-27

ORTHO*T-3 UPTAKE KIT

Applicant Ortho Diagnostics, Inc.

K number K781482

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KHQ 1978-08-14

CLINIRIA T-3 UPTAKE TEST

Applicant Miles Laboratories, Inc.

K number K781180

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KHQ 1978-05-19

T-3 UPTAKE (SORBENT) KIT

Applicant Amersham Corp.

K number K780525

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KHQ 1978-05-03

CBR-T3 UPTAKE KIT

Applicant Clinical Bioresearch

K number K780500

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KHQ 1978-03-28

REAGENT SYSTEM, ARIA II T3 UPTAKE

Applicant Bd Becton Dickinson Vacutainer Systems Preanalytic

K number K780253

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KHQ 1978-03-22

T3 UPTAKE TEST

Applicant Monobind

K number K780361

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KHQ 1978-02-23

T3 STI KIT

Applicant Polysciences, Inc.

K number K780146

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KHQ 1977-12-22

SPINSEP-T3

Applicant Nuclear Diagnostics, Inc.

K number K771854

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KHQ 1977-12-06

AMES T-3 UPTAKE STRIP TEST

Applicant Miles Laboratories, Inc.

K number K772088

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KHQ 1977-06-27

PHADEBAS T3 U TEST

Applicant Pharmacia, Inc.

K number K771078

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KHQ 1977-05-26

T3 UPTAKE REAGENT SET

Applicant The Dow Chemical Co.

K number K770845

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KHQ 1977-04-06

IN VITRO T-3 UPTAKE TEST

Applicant Clinical Assays, Inc.

K number K770480

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KHQ 1977-02-09

DATA-TOPE T3 UPTAKE PROCEDURE

Applicant Dade, Baxter Travenol Diagnostics, Inc.

K number K761281

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KHQ 1977-02-07

SPAC TM T3 UPTAKE KIT

Applicant Mallinckrodt Critical Care

K number K770033

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KHQ 1976-10-29

T-3 UPTAKE KIT

Applicant Diagnostic Products Corp.

K number K760802

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