ClearanceBrief
Panels › Immunology › Product code JZO · Class 2

System, Test, Thyroid Autoantibody

Regulation 866.5870

0510(k)s in 12 months (92 all time)
1recalls in 12 months (18 all time)
17recalls that name a 510(k)
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Top companies in JZO

Company510(k)sRecalls
Siemens Healthcare Diagnostics, Inc.29
American Laboratory Products Co., Ltd.90
Roche Diagnostics70
Brahms Diagnostica, LLC50
Elias U.S.A., Inc.50
Diagnostic Products Corp.40
Kronus40
Pharmacia & Upjohn Co.40
Axis-Shield Diagnostics, Ltd.30
Beckman Coulter, Inc.30
DateFirm and productCodeLinked 510(k)
Jan 2, 2026Roche Diagnostics Operations, Inc.
The Elecsys Anti-TSHR immunoassay is a three-step competitive immunoassay with streptavidin-coated microparticles and electrochemiluminescence detection. Patient serum sample is incubated with pretre
Open, Classified		 JZOK193313
May 27, 2025Mckesson Medical-Surgical Inc. Corporate Office
ABBOTT DIAGNOSTICS ARC T-UPTAKE ASSAY (100TST/BX) ABBDIA REAGENT.
Open, Classified		 JZONone listed
May 27, 2025Mckesson Medical-Surgical Inc. Corporate Office
ABBOTT DIAGNOSTICS ARC ANTI-TPO ASSAY 100TST B REAGENT.
Open, Classified		 JZOK052407
Sep 27, 2024Siemens Healthcare Diagnostics, Inc.
Atellica IM aTPO Assay, Material Number 10995466 (100 Test) and 10995467 (500 Test)
Open, Classified		 JZOK003291
Sep 27, 2024Siemens Healthcare Diagnostics, Inc.
ADVIA Centaur aTPO Assay, Material Number 10630886 (100 Test) and 10630887 (500 Test)
Open, Classified		 JZOK003291
May 23, 2024Siemens Healthcare Diagnostics, Inc.
IMMULITE 2000 Anti-TG Ab Catalog # L2KTG6 (600 Tests), SMN 10381655, System, Test, Thyroid Autoantibody.
Open, Classified		 JZOK991094
May 23, 2024Siemens Healthcare Diagnostics, Inc.
IMMULITE 2000 Anti-TG Ab Catalog # L2KTG2 (200 Tests), SMN 10381659, System, Test, Thyroid Autoantibody.
Open, Classified		 JZOK991094
Jun 8, 2023Abbott Ireland Limited
Alinity i Anti-TPO Reagent Kit, List Number 09P3521
Open, Classified		 JZOK052407
Sep 27, 2022Siemens Healthcare Diagnostics, Inc.
IMMULITE 2000 and IMMULITE 2000 XPi Thyroid Stimulating Immunoglobulins (TSI) Siemens Material Number (SMN): 10876421 US; 10713448 (OUS)
Open, Classified		 JZOK152061
Aug 20, 2020Roche Diagnostics Operations, Inc.
Elecsys Anti-TPO Assay on cobas e analyzers 411, 601, 602, Catalog Number 06368590190
Terminated		 JZOK051890
Dec 7, 2018Siemens Healthcare Diagnostics, Inc
Atellica IM aTG (500 test kit) Siemens Material Number (SMN): 10995462
Terminated		 JZOK012777
Dec 7, 2018Siemens Healthcare Diagnostics, Inc
Siemens Atellica IM aTG (100 test kit) Siemens Material Number (SMN): 10995461
Terminated		 JZOK012777
Dec 7, 2018Siemens Healthcare Diagnostics, Inc
SiemensADVIA Centaur aTG (500 test kit) Siemens Material Number (SMN): 10492399
Terminated		 JZOK012777
Dec 7, 2018Siemens Healthcare Diagnostics, Inc
Siemens ADVIA Centaur aTG (100 test kit) Siemens Material Number (SMN): 10492398
Terminated		 JZOK012777
May 15, 2017Tosoh Bioscience, Inc.
AIA-PACK TgAb CONTROL SET
Terminated		 JZOK981522
May 15, 2017Tosoh Bioscience, Inc.
AIA-PACK TPOAb CONTROL SET
Terminated		 JZOK981521
Feb 23, 2012Tosoh Bioscience Inc
Thyroglobulin Antibody (TgAB) Calibrator - Product Usage: intended for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of anti-thyroglobulin antibodies (TgAb) in human serum on specific
Terminated		 JZOK981522
Apr 6, 2005Diasorin Inc.
Data reduction program software written specifically for Bio-Tek ELx800 (DiaSorin part # 15713) automated microtiter plate reader with use of Diastat Anti-Thyroglobulin Assay (manufacturer part #7700)
Terminated		 JZOK952183

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