Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

System, Test, Thyroid Autoantibody

FDA product code JZO · 92 cleared devices

Class 2 Immunology

Regulation: 21 CFR 866.5870
Review panel: IM
Implant: No
Life sustaining: No
Third party review: Yes
GMP exempt: No
Clearance span: 1976-07-20 – 2025-10-17

JZO 2025-10-17

ADVIA Centaur Anti-Thyroid Peroxidase II

Applicant Siemens Healthcare Diagnostics, Inc.

K number K250250

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JZO 2024-08-09

Access TPO Antibody

Applicant Beckman Coulter, Inc.

K number K240469

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JZO 2023-09-26

Access Thyroglobulin Antibody II

Applicant Beckman Coulter, Inc.

K number K213517

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JZO 2023-09-15

Elecsys Anti-Tg

Applicant Roche Diagnostics

K number K222610

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JZO 2020-02-27

Elecsys Anti-TSHR

Applicant Roche Diagnostics

K number K193313

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JZO 2016-03-25

EliA anti-TG Immunoassay, EliA anti-TPO Immunoassay, EliA Thyroid Positive Control 250, EliA Thyroid Positive Control 2500/5000

Applicant Phadia AB

K number K151799

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JZO 2016-03-03

IMMULITE 2000 TSI Assay, IMMULITE 2000 TSI Calibration Verification Material

Applicant Siemens Healthcare Diagnostics, Inc.

K number K152061

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JZO 2010-05-18

THYRETAIN TM TSI REPORTER BIOASSAY

Applicant Diagnostic Hybrids, Inc.

K number K092229

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JZO 2009-09-03

THERATEST EL-ANTI-TPO AND THERATEST EL-ANTI-THYROGLOBULIN, MODEL 104-119, 103-120

Applicant Theratest Laboratories, Inc.

K number K090760

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JZO 2009-05-21

THYROID STIMULATING IMMUNOGLOBULIN REPORTER ASSAY

Applicant Diagnostic Hybrids, Inc.

K number K083391

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JZO 2008-07-28

ELECSYS ANTI-TSHR IMMUNOASSAY, ELECSYS PRECICONTROL THYROAB

Applicant Roche Diagnostics Corp.

K number K080092

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JZO 2008-05-22

KRONUS TSH RECEPTOR AUTOANTIBODY (TRAB) ELISA ASSAY KIT

Applicant Kronus Market Development Associates, Inc.

K number K080159

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JZO 2006-11-21

FIDIS TM THYRO, MODEL MX002

Applicant Biomedical Diagnostics (Bmd) SA

K number K061794

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JZO 2006-07-18

ARCHITECT ANTI-TPO IMMUNOASSAY, CALIBRATORS & CONTROLS

Applicant Fisher Diagnostics

K number K052407

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JZO 2006-07-06

ACCESS TPO ANTIBODY, AND ACCESS TPO ANTIBODY CALIBRATORS, MODELS A12985 AND A18227

Applicant Beckman Coulter, Inc.

K number K061382

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JZO 2006-05-10

ARCHITECT ANTI-TG IMMUNOASSAY REAGENTS, CALIBRATORS, CONTROLS AND SYSTEM ASSAY CD-ROM

Applicant Fisher Diagnostics

K number K052308

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JZO 2006-02-07

ROCHE ELECSYS ANTI-TG

Applicant Roche Diagnostics Corp.

K number K053426

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JZO 2005-08-04

ROCHE DIAGNOSTICS COBAS ELECSYS ANTI-TPO

Applicant Roche Diagnostics Corp.

K number K051890

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JZO 2004-03-22

ZEUS SCIENTIFIC, INC., ATHENA MULTI-LYTE TPO/TG IGG TEST SYSTEM

Applicant Zeus Scientific, Inc.

K number K033977

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JZO 2004-03-22

BRAHMS DIAGNOSTICA LUMITEST TRAK HUMAN

Applicant Brahms Diagnostica, LLC

K number K033454

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JZO 2003-09-10

TSH RECEPTOR ANTIBODY (TRAB) COATED TUBE (CT) ASSAY KIT

Applicant Kronus Market Development Associates, Inc.

K number K032134

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JZO 2003-02-06

SERAQUEST ANTI-THYROID PEROXIDASE (TPO)

Applicant Quest Intl., Inc.

K number K023593

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JZO 2002-08-05

ELECSYS ANTI-TG TEST SYSTEM

Applicant Roche Diagnostics Corp.

K number K020672

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JZO 2002-05-02

DIASTAT ANTI-THYROID PEROXIDASE ELISA MODEL #300

Applicant Axis-Shield Diagnostics, Ltd.

K number K020687

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JZO 2002-05-02

ABBOTT AXSYM ANTI-THYROGLOBULIN, MODELS 5F5B COMPRISING STANDARD/CALIBRATORS

Applicant Axis-Shield Diagnostics, Ltd.

K number K020349

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JZO 2002-05-02

ABBOTT AXSYM ANTI-THYROID-PEROXIDASE, MODELS5F57 COMPRISING STANDARDS/CALIBRATORS

Applicant Axis-Shield Diagnostics, Ltd.

K number K020348

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JZO 2001-10-22

ACS: 180 AND ADVIA CENTAUR ANTI-THYROGLOBULIN IMMUNOASSAYS

Applicant Bayer Corp.

K number K012777

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JZO 2001-06-06

TPO IGG ANTIBODY EIA TEST

Applicant Scimedx Corp.

K number K011082

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JZO 2001-05-30

ALPCO MILENIA ANTI-TG EIA

Applicant American Laboratory Products Co., Ltd.

K number K011415

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JZO 2001-05-24

ALPCO MILENIA ANTI-TPO ELISA

Applicant American Laboratory Products Co., Ltd.

K number K011201

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JZO 2000-12-05

BAYER DIAGNOSTICS ACS:180 AND ADVIA CENTAUR ANTI-TPO ASSAY

Applicant Bayer Diagnostics Corp.

K number K003291

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JZO 2000-11-27

VARELISA TG (THYROGLOBULIN) ANTIBODIES,

Applicant Pharmacia & Upjohn Co.

K number K003414

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JZO 2000-05-17

ELECSYS ANTI-THYROID PEROXIDASE ANTIBODY TEST SYSTEM

Applicant Roche Diagnostics Corp.

K number K000155

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JZO 2000-03-17

BRAHMS DIAGNOSTICA LUMITEST ANTI-TPO

Applicant Brahms Diagnostica, LLC

K number K000287

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JZO 2000-03-17

BRAHMS DIAGNOSTICA LUMITEST ANTI-TG

Applicant Brahms Diagnostica, LLC

K number K000286

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JZO 2000-02-18

MODIFICATION TO ZEUS SCIENTIFIC, INC., TPO IGG ELISA TEST SYSTEM

Applicant Zeus Scientific, Inc.

K number K000362

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JZO 2000-01-05

VARELISA TPO ANTIBODIES, MODEL 12348/12396

Applicant Pharmacia & Upjohn Co.

K number K993585

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JZO 1999-11-12

BRAHMS DIAGNOSTICA DYNOTEST ANTI-TPO

Applicant Brahms Diagnostica, LLC

K number K992791

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JZO 1999-11-12

BRAHMS DIAGNOSTICA DYNOTEST ANTI-TG

Applicant Brahms Diagnostica, LLC

K number K992790

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JZO 1999-05-13

IMMULITE 2000 ANTI-TPO AB, MODEL L2KT02, L2KT06

Applicant Diagnostic Products Corp.

K number K991096

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JZO 1999-05-13

IMMULITE 2000 ANTI-TG AB, MODEL L2KTG2, L2KTG6

Applicant Diagnostic Products Corp.

K number K991094

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JZO 1999-02-02

IS ANTI-TPO IGG ELISA TEST SYSTEM

Applicant Columbia Bioscience, Inc.

K number K984228

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JZO 1999-02-02

ANTI-THYROGLOBULIN EIA DIAGNOSTIC TEST KIT

Applicant The Binding Site, Ltd.

K number K984165

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JZO 1999-02-02

ANTI-TPO EIA DIAGNOSTIC TEST KIT

Applicant The Binding Site, Ltd.

K number K984163

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JZO 1999-01-26

NICHOLS ADVANTAGE THYROGLOBULIN AUTOANTIBODIES (TGAB) ASSAY

Applicant Nichols Institute Diagnostics

K number K983992

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JZO 1998-12-07

ANTI-TG IGG ELISA TEST SYSTEM

Applicant Columbia Bioscience, Inc.

K number K983553

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JZO 1998-10-16

NICHOLS ADVANTAGE CHEMILUMINESCENCE THYROID PEROXIDASE AUTOANTIBODIES IMMUNOASSAY, MODEL # 62-701521

Applicant Nichols Institute Diagnostics

K number K982866

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JZO 1998-10-08

AIA-PACK TGAB ASSAY

Applicant Tosoh Medics, Inc.

K number K981522

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JZO 1998-10-08

AIA-PACK TPOAB ASSAY

Applicant Tosoh Medics, Inc.

K number K981521

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JZO 1998-07-07

UNICAP THYROID PEROXIDASE IGG

Applicant Pharmacia & Upjohn Co.

K number K981930

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JZO 1998-07-07

UNICAP THYROGLOBULIN IGG ASSAY, UNICAP THYROID PEROXIDASE IGG ASSAY

Applicant Pharmacia & Upjohn Co.

K number K981559

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JZO 1998-05-01

IMMULITE ANTI-TG AB

Applicant Diagnostic Products Corp.

K number K980206

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JZO 1997-07-14

THYROGLOBULIN ASSAY SYSTEM

Applicant American Laboratory Products Co., Ltd.

K number K972190

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JZO 1997-01-17

IMMULITE ANTI-TPO-AB(LKTOI,LKT05,LKTOZ

Applicant Diagnostic Products Corp.

K number K963695

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JZO 1996-06-20

THYROGLOBULIN ANTIBODY ELISA

Applicant Immco Diagnostics, Inc.

K number K960370

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JZO 1996-06-20

THYROID PEROXIDASE ANTIBODY ELISA

Applicant Immco Diagnostics, Inc.

K number K960369

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JZO 1995-06-30

DIASTAT ANTI-THYROGLOBULIN KIT

Applicant Shield Diagnostics, Ltd.

K number K952183

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JZO 1995-06-30

DIASTAT ANTI-THYROID PEROXIDASE KIT

Applicant Shield Diagnostics, Ltd.

K number K951487

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JZO 1995-06-20

ORGENTEC ANTI-TG ELISA

Applicant American Laboratory Products Co., Ltd.

K number K952130

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JZO 1995-06-20

ORGENTEC ANTI-TPO ELISA

Applicant American Laboratory Products Co., Ltd.

K number K952129

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JZO 1995-04-24

ORGENTEC THYROGLOBULIN PIA (PIN IMMUNO ASSAY)

Applicant American Laboratory Products Co., Ltd.

K number K950217

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JZO 1995-04-21

ORGENTEC ANTI-TPO PIA (PIN IMMUNO ASSAY)

Applicant American Laboratory Products Co., Ltd.

K number K950090

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JZO 1995-04-21

ORGENTEC ANTI-TG PIA (PIN IMMUNO ASSAY)

Applicant American Laboratory Products Co., Ltd.

K number K950089

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JZO 1995-04-21

ORGENTEC ANTI-TG/ANTI-TPO PIA (PIN IMMUNO ASSAY)

Applicant American Laboratory Products Co., Ltd.

K number K950088

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JZO 1993-05-14

THYROID PEROXIDASE AUTO ANTIBODIES(TPO) IMMUN KIT

Applicant Nichols Institute

K number K931311

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JZO 1993-03-16

QUANTA LITE(TM) THYROID M ELISA

Applicant Inova Diagnostics, Inc.

K number K930485

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JZO 1993-02-23

THYROID MICROSOMAL ANTIGEN AUTO-ANTIBODY ENZYME

Applicant Joldon Diagnostics

K number K930274

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JZO 1993-02-05

THYROGLOBULIN AUTO-ANTIBODY EIA TEST KIT

Applicant Joldon Diagnostics

K number K925194

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JZO 1993-01-26

ENCORE THYROGLOBULIN IGE, IGA AND IGM EIA

Applicant Clark Laboratories, Inc.

K number K925826

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JZO 1993-01-21

AUTOSTAT ANTI-THYROID MICROSOMAL KIT

Applicant Cogent Diagnotics , Ltd.

K number K925785

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JZO 1993-01-21

AUTOSTAT ANTITHYROGLOBIN

Applicant Cogent Diagnotics , Ltd.

K number K925784

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JZO 1993-01-14

ELIAS TMAB

Applicant Elias U.S.A., Inc.

K number K925923

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JZO 1993-01-14

ELIAS TGAB

Applicant Elias U.S.A., Inc.

K number K925922

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JZO 1992-04-08

SYNELISA TGAB/TMAB

Applicant Elias U.S.A., Inc.

K number K915135

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JZO 1992-04-08

SYNELISA TGAB

Applicant Elias U.S.A., Inc.

K number K915134

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JZO 1992-04-08

SYNELISA TMAB

Applicant Elias U.S.A., Inc.

K number K915133

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JZO 1992-03-30

KRONUS KALIBRE THYROID PEROXIDASE ANTIBODY EIA KIT

Applicant Kronus

K number K915429

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JZO 1992-03-30

KRONUS KALIBRE THYROGLOBULIN ANTIBODY EIA KIT

Applicant Kronus

K number K915428

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JZO 1991-01-25

IMMUNOWELL THYROGLOBULIN TEST

Applicant General Biometrics, Inc.

K number K905485

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JZO 1990-10-15

NOVA LITE TM THYROID

Applicant Inova Diagnostics, Inc.

K number K904224

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JZO 1989-07-25

MODIFIED KRONUS TEST KIT FOR ANTIBODIES TO (TPO)

Applicant Kronus

K number K894364

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JZO 1989-07-25

ANTI-THYROGLOBULIN TEST KIT

Applicant Kronus

K number K894203

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JZO 1988-06-06

KALLESTAD QUANTAFLUOR ANTITHYROID ANTIBODY TEST

Applicant Kallestad Diag, A Div. of Erbamont, Inc.

K number K881933

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JZO 1987-05-15

I-125 ANTI-THYROGLOBULIN ANTIBODY IRMA TEST KIT

Applicant Cronus

K number K871193

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JZO 1987-02-18

SERA-TEK MICROSOMAL ANTIBODY TEST

Applicant Miles Laboratories, Inc.

K number K865053

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JZO 1986-09-08

125-I TSH RECEPTOR ANTIBODY KIT

Applicant Cronus

K number K863006

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JZO 1984-10-22

MEDICA IIF-ANTI-THYROID ANTIBODY TEST

Applicant Medical Diagnostics, Ca.

K number K843343

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JZO 1984-10-22

TSH RECEPTOR ANTIBODY KIT 125I TSH

Applicant Clinetics Corp.

K number K841580

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JZO 1982-06-09

CORDIA TG

Applicant Cordis Corp.

K number K821489

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JZO 1981-05-01

ANTITHYROID ANTIBODY IMMUNOFLUORESCENT

Applicant Immuno-Products Industries

K number K810982

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JZO 1979-12-31

AGGLUTINOTEST-THYROGLOBULIN

Applicant Volu Sol Medical Industries

K number K791458

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JZO 1976-07-20

TEST, (IVDP) THYROID ANTIBODY

Applicant Zeus Scientific, Inc.

K number K760154

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