FDA.reportPublic FDA data

Multiple coagulation factor 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 qualitative and/or quantitative determination of one or multiple coagulation factors, coagulation intermediates and/or their activated components in a clinical specimen.
GUDID devices
52
Last updated
2025-06-23 15:21:54

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
20812747018323TEG6s HEMOSTASIS SYSTEMHAEMONETICS CORPORATION07-601-US2017-04-25
20812747018538Global Hemostasis - HNHAEMONETICS CORPORATION07-604-US2024-04-10
10711234101230Hemochron Whole Blood Coagulation SystemACCRIVA DIAGNOSTICS HOLDINGS, INC.PDAO2016-09-22
10711234202036Hemochron Whole Blood Coagulation SystemACCRIVA DIAGNOSTICS HOLDINGS, INC.R-HRT480P2016-09-22
10711234202050Hemochron Whole Blood Coagulation SystemACCRIVA DIAGNOSTICS HOLDINGS, INC.R-PRT2002016-09-22
10711234202067Hemochron Whole Blood Coagulation SystemACCRIVA DIAGNOSTICS HOLDINGS, INC.R-PRT4002016-09-22
10711234202081Hemochron Whole Blood Coagulation SystemACCRIVA DIAGNOSTICS HOLDINGS, INC.R-HRT480PK2016-09-22
10711234202098Hemochron Whole Blood Coagulation SystemACCRIVA DIAGNOSTICS HOLDINGS, INC.R-PRT200K2016-09-22
10711234202104Hemochron Whole Blood Coagulation SystemACCRIVA DIAGNOSTICS HOLDINGS, INC.R-PRT400K2016-09-22
10711234202111Hemochron Whole Blood Coagulation SystemACCRIVA DIAGNOSTICS HOLDINGS, INC.PDAOK2016-09-22
20812747018460Hemostasis SystemHAEMONETICS CORPORATION07-605-US2021-06-17
00842768007163Imidazole Buffer SolutionSiemens Healthcare Diagnostics Products GmbH104460322020-09-24
20812747018002TEG5000 HEMOSTASIS SYSTEMHAEMONETICS CORPORATION07-0042017-06-16
20812747018019TEG5000 HEMOSTASIS SYSTEMHAEMONETICS CORPORATION07-0062017-06-16
04260160470044ROTEM®Tem Innovations GmbHin-tem®2016-09-16
04260160470068ROTEM®Tem Innovations GmbHap-tem®2016-09-16
04260160470075ROTEM®Tem Innovations GmbHfib-tem®2016-09-16
04260160470082ROTEM®Tem Innovations GmbHhep-tem®2016-09-16
04260160470099ROTEM®Tem Innovations GmbHstar-tem® 202016-09-16
04260160470242ROTEM®Tem Innovations GmbHex-tem®2016-09-16
00842768003981Dade® Owren's Veronal BufferSiemens Healthcare Diagnostics Products GmbH104457242016-09-24
00842768007170Kaolin SuspensionSiemens Healthcare Diagnostics Products GmbH104460332016-09-24
00842768017742Washing Solution for Coagulation AnalyzersSiemens Healthcare Diagnostics Products GmbH104466842016-09-24
00842768027611INNOVANCE® D-Dimer Sample DiluentSiemens Healthcare Diagnostics Products GmbH104870392016-09-24
00842768039416Dade® CA System BufferSiemens Healthcare Diagnostics Products GmbH108734402016-09-24
00843876000015CRYOcheck™ Pooled Normal PlasmaPrecision Biologic IncCCN-102016-09-23
00843876000039CRYOcheck™ Pooled Normal PlasmaPrecision Biologic IncCCN10-102016-09-23
00843876000046CRYOcheck™ Pooled Normal PlasmaPrecision Biologic IncCCN-402016-09-23
00843876000220CRYOcheck™ Factor II Deficient PlasmaPrecision Biologic IncFDP02-152016-09-23
00843876000237CRYOcheck™ Factor V Deficient PlasmaPrecision Biologic IncFDP05-102016-09-23
00843876000244CRYOcheck™ Factor V Deficient PlasmaPrecision Biologic IncFDP05-152016-09-23
00843876000251CRYOcheck™ Factor VII Deficient PlasmaPrecision Biologic IncFDP07-102016-09-23
00843876000268CRYOcheck™ Factor VII Deficient PlasmaPrecision Biologic IncFDP07-152016-09-23
00843876000275CRYOcheck™ Factor VIII Deficient PlasmaPrecision Biologic IncFDP08-102016-09-23
00843876000282CRYOcheck™ Factor VIII Deficient PlasmaPrecision Biologic IncFDP08-152016-09-23
00843876000299CRYOcheck™ Factor VIII Deficient PlasmaPrecision Biologic IncFDP08-402016-09-23
00843876000305CRYOcheck™ Factor IX Deficient PlasmaPrecision Biologic IncFDP09-102016-09-23
00843876000312CRYOcheck™ Factor IX Deficient PlasmaPrecision Biologic IncFDP09-152016-09-23
00843876000329CRYOcheck™ Factor X Deficient PlasmaPrecision Biologic IncFDP10-102016-09-23
00843876000336CRYOcheck™ Factor X Deficient PlasmaPrecision Biologic IncFDP10-152016-09-23
00843876000343CRYOcheck™ Factor XI Deficient PlasmaPrecision Biologic IncFDP11-102016-09-23
00843876000350CRYOcheck™ Factor XI Deficient PlasmaPrecision Biologic IncFDP11-152016-09-23
00843876000367CRYOcheck™ Factor XII Deficient PlasmaPrecision Biologic IncFDP12-102016-09-23
00843876000374CRYOcheck™ Factor XII Deficient PlasmaPrecision Biologic IncFDP12-152016-09-23
00843876000381CRYOcheck™ Prekallikrein Deficient PlasmaPrecision Biologic IncFDPK-102016-09-23
00883205004550ViscoStat ClearULTRADENT PRODUCTS, INC.S6462018-04-28
00883205103192ViscoStat ClearULTRADENT PRODUCTS, INC.64102018-04-28
00883205103208ViscoStat ClearULTRADENT PRODUCTS, INC.64092018-04-28
00883205106889ViscoStat ClearULTRADENT PRODUCTS, INC.64072018-04-28
00883205106896ViscoStat ClearULTRADENT PRODUCTS, INC.64082018-04-28
00817274020425Drew ScientificDREW SCIENTIFIC, INC.R12A24D-BUL2016-09-09
00366975013347FAS-TRACTBENCO DENTAL SUPPLY CO.4006-9062018-12-05