FDA.reportPublic FDA data

Prothrombin time (PT) IVD, control

Definition
A material which is used to verify the performance of an assay 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).
GUDID devices
16
Last updated
2026-06-04 19:44:10

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00054749004843i-STAT PTplus Control Level 1Abbott Point of Care Inc.06P17-172024-01-10
00054749004850i-STAT PTplus Control Level2Abbott Point of Care Inc.06P17-182024-01-10
09360136000055Xprecia™ Systems PT ControlsUNIVERSAL BIOSENSORS PTY LTD905062024-08-27
00815696021280George King Coumadin® PlasmaGEORGE KING BIO-MEDICAL, INC4000-200.02022-01-20
08426950485629HemosIL INR ValidateINSTRUMENTATION LABORATORY COMPANY000200105002016-09-23
00815696021129George King Coumadin® PlasmaGEORGE KING BIO-MEDICAL, INC4000-300.02020-03-27
00815696021136George King Coumadin® PlasmaGEORGE KING BIO-MEDICAL, INC4000-330.02020-03-27
00843876000107CRYOcheck™ Abnormal 1 ControlPrecision Biologic IncCCA1-102016-09-23
00843876000114CRYOcheck™ Abnormal 2 ControlPrecision Biologic IncCCA2-102016-09-23
00054749001217i-STATABBOTT POINT OF CARE INC.06P17-132016-09-09
00054749001224i-STATABBOTT POINT OF CARE INC.06P17-142016-09-09
00815696020146George King Coumadin® PlasmaGEORGE KING BIO-MEDICAL, INC4000 - 1.02016-08-19
00815696020429George King Coumadin® PlasmaGEORGE KING BIO-MEDICAL, INC4000 - 1.52016-08-19
00815696020719George King Multi-Coumadin® KitGEORGE KING BIO-MEDICAL, INC9400 - 252016-09-24
00815696021099George King Coumadin® Plasma Convenience KitGEORGE KING BIO-MEDICAL, INC0090-302017-07-24
00630414170794Xprecia™ System PT ControlsSiemens Healthcare Diagnostics Inc.108736332016-12-16