FDA.reportPublic FDA data

Troponin I IVD, control

Definition
A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of troponin I in a clinical specimen.
GUDID devices
20
Last updated
2026-01-07 15:15:56

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
10758750032891VITROSORTHO CLINICAL DIAGNOSTICS69000402025-12-30
00054749004911i-STAT hs-TnI Calibration Verification, Levels 1-3Abbott Point of Care Inc.06P17-202025-05-02
00054749004928i-STAT hs-TnI Control Level 1Abbott Point of Care Inc.06P17-212025-05-02
00054749004935i-STAT hs-TnI Control Level 2Abbott Point of Care Inc.06P17-222025-05-02
00054749004942i-STAT hs-TnI Control Level 3Abbott Point of Care Inc.06P17-232025-05-02
00054749001132i-STATABBOTT POINT OF CARE INC.06P17-092023-06-23
00054749001149i-STATABBOTT POINT OF CARE INC.06P17-102023-06-23
00054749001156i-STATABBOTT POINT OF CARE INC.06P17-112023-06-23
00054749001163i-STATABBOTT POINT OF CARE INC.06P17-122023-06-23
00380740194055AlinityABBOTT IRELAND04Z21102022-07-08
00842768037511Dimension Vista® / Dimension® EXL™ LCTNI CON LSiemens Healthcare Diagnostics Inc.107079562020-09-24
00630414600116Atellica IM TnI-Ultra MCMSiemens Healthcare Diagnostics Inc.109956982020-09-24
00630414971391IMMULITE® Systems TPI Calibration Verification Material Troponin ISIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD103737072020-09-24
00842768037528Dimension Vista® / Dimension® EXL™ LCTNI CON MSiemens Healthcare Diagnostics Inc.107079572020-09-24
00842768037535Dimension Vista® / Dimension® EXL™ LCTNI CON HSiemens Healthcare Diagnostics Inc.107079582020-09-24
00380740175481ARCHITECTABBOTT IRELAND02R98102019-12-03
00630414006772Atellica IM TNIH MCMSiemens Healthcare Diagnostics Inc.109978422018-08-21
00630414515892ADVIA Centaur® TnI-Ultra MCMSiemens Healthcare Diagnostics Inc.103176262016-09-24
00630414602936ADVIA Centaur TNIH MCMSiemens Healthcare Diagnostics Inc.109947762018-08-10
00380740003197ARCHITECTABBOTT LABORATORIES2K41-102016-06-06