FDA.reportPublic FDA data

Prothrombin time (PT) IVD, reagent

Definition
A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the quantitative measurement of the prothrombin time (PT) of a clinical specimen, with or without standardization to the international normalized ratio (INR).
GUDID devices
28
Last updated
2026-06-04 19:44:10

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00627944000035QuikCoag PT-HSBiomedica Diagnostics Inc10 mL2016-09-22
00630414639871Dade InnovinSiemens Healthcare Diagnostics Products GmbH108739322024-03-25
00630414639888Dade InnovinSiemens Healthcare Diagnostics Products GmbH108739342024-03-25
00630414639963Thromborel SSiemens Healthcare Diagnostics Products GmbH108739312024-03-25
00630414640006Dade InnovinSiemens Healthcare Diagnostics Products GmbH108739332024-03-25
10859394006023Phosphoplastin RLR 2 DIAGNOSTICS, INC.11-3052016-11-15
10859394006030Phosphoplastin RLR 2 DIAGNOSTICS, INC.11-3102016-11-15
M52552480Thromboplastin-LI Reagent KitHELENA LABORATORIES CORPORATION52482016-09-07
M52552490Thromboplastin-LI Reagent KitHELENA LABORATORIES CORPORATION52492016-09-07
09360136000093Xprecia Prime™ PT/INR Test StripsUNIVERSAL BIOSENSORS PTY LTD301062024-08-27
00842768018749Thromborel SSiemens Healthcare Diagnostics Products GmbH108739312024-03-25
00842768019586Dade InnovinSiemens Healthcare Diagnostics Products GmbH108739332024-03-25
00842768019593Dade InnovinSiemens Healthcare Diagnostics Products GmbH108739322024-03-25
00842768019609Dade InnovinSiemens Healthcare Diagnostics Products GmbH108739342024-03-25
00850053916182IDG/SanzayIDG/SANZAY Corporation12024-01-12
10054749000170i-STATABBOTT POINT OF CARE INC.03P89-242016-09-09
10711234103036Hemochron Whole Blood Microcoagulation SystemACCRIVA DIAGNOSTICS HOLDINGS, INC.J2012016-09-21
10711234103043Hemochron Whole Blood Microcoagulation SystemACCRIVA DIAGNOSTICS HOLDINGS, INC.J201C2016-09-22
00842768003783Dade® Innovin®Siemens Healthcare Diagnostics Products GmbH104457042016-09-24
00842768003790Dade® Innovin®Siemens Healthcare Diagnostics Products GmbH104457052016-09-24
00842768003806Dade® Innovin®Siemens Healthcare Diagnostics Products GmbH104457062016-09-24
00627944000011QuikCoag PT-HSBiomedica Diagnostics Inc2 mL2016-09-22
00627944000028QuikCoag PT-HSBiomedica Diagnostics Inc4 mL2016-09-22
10627944000032QuikCoag PT-HSBiomedica Diagnostics Inc10 mL2016-09-22
00630414023472Dade® Innovin®Siemens Healthcare Diagnostics Products GmbH108735662017-02-15
00630414023489Dade® Innovin®Siemens Healthcare Diagnostics Products GmbH108735672017-02-15
00630414023496Dade® Innovin®Siemens Healthcare Diagnostics Products GmbH108735682017-02-15
00630414034348Xprecia™ System PT/INR StripsSiemens Healthcare Diagnostics Inc.110656452017-03-01