Product code JZO— Immunology
125-I TSH RECEPTOR ANTIBODY KIT
- Classification name
- System, Test, Thyroid Autoantibody
- Device class
- Class 2
- Regulation
- 21 CFR 866.5870
- Advisory panel
- Immunology
- Total cleared
- 92
- First cleared
- Most recent
Market context for product code JZO
FDA has cleared devices under product code JZO between 1976 and 2025, filed by 42 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
last 15 years- 2025
- 2024
- 2023
- 2020
- 2016
- 2010
- 2009
- 2008
- 2006
- 2005
- 2004
- 2003
- 2002
- 2001
- 2000
Top applicants under product code JZO
Recent clearances under product code JZO
- K250250 — ADVIA Centaur Anti-Thyroid Peroxidase II
- K240469 — Access TPO Antibody
- K213517 — Access Thyroglobulin Antibody II
- K222610 — Elecsys Anti-Tg
- K193313 — Elecsys Anti-TSHR
- K151799 — EliA anti-TG Immunoassay, EliA anti-TPO Immunoassay, EliA Thyroid Positive Control 250, EliA Thyroid Positive Control 2500/5000
- K152061 — IMMULITE 2000 TSI Assay, IMMULITE 2000 TSI Calibration Verification Material
- K092229 — THYRETAIN TM TSI REPORTER BIOASSAY
- K090760 — THERATEST EL-ANTI-TPO AND THERATEST EL-ANTI-THYROGLOBULIN, MODEL 104-119, 103-120
- K083391 — THYROID STIMULATING IMMUNOGLOBULIN REPORTER ASSAY
- K080092 — ELECSYS ANTI-TSHR IMMUNOASSAY, ELECSYS PRECICONTROL THYROAB
- K080159 — KRONUS TSH RECEPTOR AUTOANTIBODY (TRAB) ELISA ASSAY KIT
- K061794 — FIDIS TM THYRO, MODEL MX002
- K052407 — ARCHITECT ANTI-TPO IMMUNOASSAY, CALIBRATORS & CONTROLS
- K061382 — ACCESS TPO ANTIBODY, AND ACCESS TPO ANTIBODY CALIBRATORS, MODELS A12985 AND A18227
- K052308 — ARCHITECT ANTI-TG IMMUNOASSAY REAGENTS, CALIBRATORS, CONTROLS AND SYSTEM ASSAY CD-ROM
- K053426 — ROCHE ELECSYS ANTI-TG
- K051890 — ROCHE DIAGNOSTICS COBAS ELECSYS ANTI-TPO
- K033454 — BRAHMS DIAGNOSTICA LUMITEST TRAK HUMAN
- K033977 — ZEUS SCIENTIFIC, INC., ATHENA MULTI-LYTE TPO/TG IGG TEST SYSTEM
- K032134 — TSH RECEPTOR ANTIBODY (TRAB) COATED TUBE (CT) ASSAY KIT
- K023593 — SERAQUEST ANTI-THYROID PEROXIDASE (TPO)
- K020672 — ELECSYS ANTI-TG TEST SYSTEM
- K020348 — ABBOTT AXSYM ANTI-THYROID-PEROXIDASE, MODELS5F57 COMPRISING STANDARDS/CALIBRATORS
- K020349 — ABBOTT AXSYM ANTI-THYROGLOBULIN, MODELS 5F5B COMPRISING STANDARD/CALIBRATORS
- K020687 — DIASTAT ANTI-THYROID PEROXIDASE ELISA MODEL #300
- K012777 — ACS: 180 AND ADVIA CENTAUR ANTI-THYROGLOBULIN IMMUNOASSAYS
- K011082 — TPO IGG ANTIBODY EIA TEST
- K011415 — ALPCO MILENIA ANTI-TG EIA
- K011201 — ALPCO MILENIA ANTI-TPO ELISA
- K003291 — BAYER DIAGNOSTICS ACS:180 AND ADVIA CENTAUR ANTI-TPO ASSAY
- K003414 — VARELISA TG (THYROGLOBULIN) ANTIBODIES,
- K000155 — ELECSYS ANTI-THYROID PEROXIDASE ANTIBODY TEST SYSTEM
- K000286 — BRAHMS DIAGNOSTICA LUMITEST ANTI-TG
- K000287 — BRAHMS DIAGNOSTICA LUMITEST ANTI-TPO
- K000362 — MODIFICATION TO ZEUS SCIENTIFIC, INC., TPO IGG ELISA TEST SYSTEM
- K993585 — VARELISA TPO ANTIBODIES, MODEL 12348/12396
- K992790 — BRAHMS DIAGNOSTICA DYNOTEST ANTI-TG
- K992791 — BRAHMS DIAGNOSTICA DYNOTEST ANTI-TPO
- K991094 — IMMULITE 2000 ANTI-TG AB, MODEL L2KTG2, L2KTG6
- K991096 — IMMULITE 2000 ANTI-TPO AB, MODEL L2KT02, L2KT06
- K984163 — ANTI-TPO EIA DIAGNOSTIC TEST KIT
- K984165 — ANTI-THYROGLOBULIN EIA DIAGNOSTIC TEST KIT
- K984228 — IS ANTI-TPO IGG ELISA TEST SYSTEM
- K983992 — NICHOLS ADVANTAGE THYROGLOBULIN AUTOANTIBODIES (TGAB) ASSAY
- K983553 — ANTI-TG IGG ELISA TEST SYSTEM
- K982866 — NICHOLS ADVANTAGE CHEMILUMINESCENCE THYROID PEROXIDASE AUTOANTIBODIES IMMUNOASSAY, MODEL # 62-701521
- K981521 — AIA-PACK TPOAB ASSAY
- K981522 — AIA-PACK TGAB ASSAY
- K981559 — UNICAP THYROGLOBULIN IGG ASSAY, UNICAP THYROID PEROXIDASE IGG ASSAY
- K981930 — UNICAP THYROID PEROXIDASE IGG
- K980206 — IMMULITE ANTI-TG AB
- K972190 — THYROGLOBULIN ASSAY SYSTEM
- K963695 — IMMULITE ANTI-TPO-AB(LKTOI,LKT05,LKTOZ
- K960369 — THYROID PEROXIDASE ANTIBODY ELISA
- K960370 — THYROGLOBULIN ANTIBODY ELISA
- K951487 — DIASTAT ANTI-THYROID PEROXIDASE KIT
- K952183 — DIASTAT ANTI-THYROGLOBULIN KIT
- K952129 — ORGENTEC ANTI-TPO ELISA
- K952130 — ORGENTEC ANTI-TG ELISA
- K950217 — ORGENTEC THYROGLOBULIN PIA (PIN IMMUNO ASSAY)
- K950088 — ORGENTEC ANTI-TG/ANTI-TPO PIA (PIN IMMUNO ASSAY)
- K950089 — ORGENTEC ANTI-TG PIA (PIN IMMUNO ASSAY)
- K950090 — ORGENTEC ANTI-TPO PIA (PIN IMMUNO ASSAY)
- K931311 — THYROID PEROXIDASE AUTO ANTIBODIES(TPO) IMMUN KIT
- K930485 — QUANTA LITE(TM) THYROID M ELISA
- K930274 — THYROID MICROSOMAL ANTIGEN AUTO-ANTIBODY ENZYME
- K925194 — THYROGLOBULIN AUTO-ANTIBODY EIA TEST KIT
- K925826 — ENCORE THYROGLOBULIN IGE, IGA AND IGM EIA
- K925784 — AUTOSTAT ANTITHYROGLOBIN
- K925785 — AUTOSTAT ANTI-THYROID MICROSOMAL KIT
- K925922 — ELIAS TGAB
- K925923 — ELIAS TMAB
- K915133 — SYNELISA TMAB
- K915134 — SYNELISA TGAB
- K915135 — SYNELISA TGAB/TMAB
- K915428 — KRONUS KALIBRE THYROGLOBULIN ANTIBODY EIA KIT
- K915429 — KRONUS KALIBRE THYROID PEROXIDASE ANTIBODY EIA KIT
- K905485 — IMMUNOWELL THYROGLOBULIN TEST
- K904224 — NOVA LITE TM THYROID
- K894203 — ANTI-THYROGLOBULIN TEST KIT
- K894364 — MODIFIED KRONUS TEST KIT FOR ANTIBODIES TO (TPO)
- K881933 — KALLESTAD QUANTAFLUOR ANTITHYROID ANTIBODY TEST
- K871193 — I-125 ANTI-THYROGLOBULIN ANTIBODY IRMA TEST KIT
- K865053 — SERA-TEK MICROSOMAL ANTIBODY TEST
- K863006 — 125-I TSH RECEPTOR ANTIBODY KIT
- K841580 — TSH RECEPTOR ANTIBODY KIT 125I TSH
- K843343 — MEDICA IIF-ANTI-THYROID ANTIBODY TEST
- K821489 — CORDIA TG
- K810982 — ANTITHYROID ANTIBODY IMMUNOFLUORESCENT
- K791458 — AGGLUTINOTEST-THYROGLOBULIN
- K760154 — TEST, (IVDP) THYROID ANTIBODY
Data sourced from openFDA. This site is unofficial and independent of the FDA.