FDA.reportPublic FDA data

Prothrombin time (PT) IVD, kit, clotting

Definition
A collection of reagents and other associated materials intended to be used for the quantitative measurement of the prothrombin time (PT) of a clinical specimen, with or without standardization to the international normalized ratio (INR), using a clotting method.
GUDID devices
27
Last updated
2026-06-04 19:44:10

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00054749004782i-STAT PTplus CartridgeAbbott Point of Care Inc.03P89-502024-01-10
M30401000713Alere INRatio®Alere San Diego, Inc.01000712016-10-26
M30401001393Alere INRatio®Alere San Diego, Inc.01001392016-10-26
M30499007G11Alere INRatio®2Alere San Diego, Inc.99007G12016-10-26
M30499008G11Alere INRatio®2Alere San Diego, Inc.99008G12016-10-26
08426950088530GEM Test PT CartridgesINSTRUMENTATION LABORATORY COMPANY062600300002016-09-23
08426950088554GEM Test Citrate PT CartridgesINSTRUMENTATION LABORATORY COMPANY062600320002016-09-23
08426950088561GEM Test APTT CartridgesINSTRUMENTATION LABORATORY COMPANY062600340002016-09-23
08426950452836HemosIL PT-FibrinogenINSTRUMENTATION LABORATORY COMPANY000097567102016-09-23
08426950453079HemosIL RecombiPlasTin 2G (8 mL)INSTRUMENTATION LABORATORY COMPANY000200029502016-09-23
08426950632887HemosIL ReadiPlasTin (20 mL)INSTRUMENTATION LABORATORY COMPANY000203014002016-09-23
08426950058403HemosIL PT-Fibrinogen HS PLUSINSTRUMENTATION LABORATORY COMPANY000084698102016-09-23
08426950447627HemosIL RecombiPlasTin 2G (20 mL)INSTRUMENTATION LABORATORY COMPANY000200030502016-09-23
08426950632870HemosIL ReadiPlasTin (10 mL)INSTRUMENTATION LABORATORY COMPANY000203013002016-09-23
03607450006063STA® - Néoplastine® CI Plus 5DIAGNOSTICA STAGO006062016-09-15
03607450006056STA® - Néoplastine® CI 5DIAGNOSTICA STAGO006052016-09-15
03607450006667STA® - Néoplastine® CI 10DIAGNOSTICA STAGO006662016-09-15
03607450006674STA® - Néoplastine® CI Plus 10DIAGNOSTICA STAGO006672016-09-15
15391521420234TriniCLOT™ PT HTF 20 mLTCOAG IRELAND LIMITEDT11012016-09-12
15391521420241TriniCLOT™ PT HTF 6 mLTCOAG IRELAND LIMITEDT11022016-09-12
05391521420251TriniCLOT™ PT Excel S 20 mLTCOAG IRELAND LIMITEDT11032016-09-12
05391521420268TriniCLOT™ PT Excel S 6 mLTCOAG IRELAND LIMITEDT11042016-09-12
05391521420282TriniCLOT™ PT Excel 6 mLTCOAG IRELAND LIMITEDT11062016-09-12
00842768011306Thromborel® SSiemens Healthcare Diagnostics Products GmbH104464422016-09-24
00842768011337Thromborel® SSiemens Healthcare Diagnostics Products GmbH104464452016-09-24
00630414023441Thromborel® SSiemens Healthcare Diagnostics Products GmbH108735642017-02-15
00630414023465Thromborel® SSiemens Healthcare Diagnostics Products GmbH108735652017-02-15