FDA.reportPublic FDA data

Prothrombin time (PT) IVD, kit, clotting, rapid

Definition
A collection of reagents and other associated materials intended to be used for the semi-quantitative measurement of the prothrombin time (PT) of a clinical specimen, with or without standardization to the international normalized ratio (INR), within a short period relative to standard laboratory testing procedures using a clotting method. This test is commonly used in the laboratory or in point-of-care analyses.
GUDID devices
19
Last updated
2021-10-08 08:09:40

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00860007370861Coag-senseCOAGUSENSE INC.03F73-032021-09-30
00860007370878Coag-senseCOAGUSENSE INC.03F73-052021-09-30
10861900000395Coag-Sense Test Strip Kit, 50 ct.COAGUSENSE INC.1002182021-09-09
00861900000350Coag-Sense PT/INR MeterCOAGUSENSE INC.2001072019-04-03
00861900000374Coag-Sense PT/INR Professional SystemCOAGUSENSE INC.2002222019-04-03
00861900000381Coag-Sense PT/INR Patient Self-Test SystemCOAGUSENSE INC.2002212019-04-03
00845275000528Thermo Scientific Pacific Hemostasis®Fisher Diagnostics1003532016-09-16
00845275000535Thermo Scientific Pacific Hemostasis®Fisher Diagnostics1003542016-09-16
00845275000542Thermo Scientific Pacific Hemostasis®Fisher Diagnostics1003562016-09-16
00845275000795Thermo Scientific Pacific Hemostasis®Fisher Diagnostics1003572016-09-16
00845275000801Thermo Scientific Pacific Hemostasis®Fisher Diagnostics1003622016-09-16
00861900000305Coag-SenseCOAGUSENSE INC.1001072018-09-23
00861900000312Coag-senseCOAGUSENSE INC.1002222018-09-23
00861900000329Coag-senseCOAGUSENSE INC.1002212018-09-23
00861900000336Coag-senseCOAGUSENSE INC.1002182018-09-23
00861900000343Coag-senseCOAGUSENSE INC.1002502018-09-23
00817274020142Drew ScientificDREW SCIENTIFIC, INC.014-1752016-09-09
00817274020159Drew ScientificDREW SCIENTIFIC, INC.014-175SA2016-09-09
00817274020166DrewDREW SCIENTIFIC, INC.014-1762016-09-09