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

Related Product Codes

CodeDeviceSpecialtyClassDevices
GJTPlasma, Coagulation Factor DeficientHematology217
JPASystem, Multipurpose For In Vitro Coagulation StudiesHematology211
MVLCord, RetractionUnknownU6
GGNPlasma, Coagulation ControlHematology25
KFFAssay, HeparinHematology25
KQJSystem, Fibrinogen DeterminationHematology23
GFTProtamine SulphateHematology22
DAPFibrinogen And Fibrin Split Products, Antigen, Antiserum, ControlHematology21
GGKProducts, Red-Cell Lysing ProductsHematology11
JCCPh BufferPathology11
JOZSystem, Automated Platelet AggregationHematology21

Representative GUDID Devices

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