FDA.reportPublic FDA data

Multiple coagulation factor IVD, control

Definition
A material which is used to verify the performance of an assay intended to be 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
199
Last updated
2026-03-02 20:06:52

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
20763000558189CLOTtrac™MEDTRONIC, INC.550-012026-02-22
20763000558196CLOTtrac™MEDTRONIC, INC.550-072026-02-22
20763000558202CLOTtrac™MEDTRONIC, INC.550-082026-02-22
20763000558219CLOTtrac™MEDTRONIC, INC.550-092026-02-22
20763000558226CLOTtrac™MEDTRONIC, INC.550-102026-02-22
20763000558233CLOTtrac™MEDTRONIC, INC.550-122026-02-22
08718734962779CueSee® CoagEurotrol B.V.12025-04-08
08718734962786CueSee® CoagEurotrol B.V.22025-04-08
08718734962793CueSee® CoagEurotrol B.V.32025-04-08
08718734962809CueSee® CoagEurotrol B.V.42025-04-08
08718734962816CueSee® CoagEurotrol B.V.52025-04-08
10629009091108VisuCon-L Coag Screen N PlasmaAffinity Biologicals IncLSCN012018-10-19
10629009101104VisuCon-L Coag Screen ABN1 PlasmaAffinity Biologicals IncLCSAB1012018-10-19
10629009111103VisuCon-L Coag Screen ABN2 PlasmaAffinity Biologicals IncLCSAB2012018-10-19
00864608000226ExpertCor RoutineDSRV Inc013062024-05-21
00842768019456Dade Ci-Trol Coagulation Control Level 3Siemens Healthcare Diagnostics Products GmbH108738442024-03-25
00842768019463Dade Ci-Trol Coagulation Control Level 2Siemens Healthcare Diagnostics Products GmbH108738432024-03-25
00842768019470Dade Ci-Trol Coagulation Control Level 1Siemens Healthcare Diagnostics Products GmbH108738422024-03-25
00842768019531Dade Ci-Trol Heparin Control, HighSiemens Healthcare Diagnostics Products GmbH108738342024-03-25
00842768019548Dade Ci-Trol Heparin Control, LowSiemens Healthcare Diagnostics Products GmbH108738332024-03-25
00842768018589Control Plasma PSiemens Healthcare Diagnostics Products GmbH108738912024-02-19
00842768018909Control Plasma N Siemens Healthcare Diagnostics Products GmbH108738742024-02-19
00850053916212IDG/SanzayIDG/SANZAY Corporation12024-01-12
00850053916229IDG/SanzayIDG/SANZAY Corporation12024-01-12
00763000561826NAMEDTRONIC, INC.550-112023-03-27
00815696021341George King SysCOR-40 Control KitGEORGE KING BIO-MEDICAL, INC0065-402023-03-15
04260160470617ROTEM®Tem Innovations GmbHsigma ROTROL N2022-10-04
04260160470624ROTEM®Tem Innovations GmbHsigma ROTROL P2022-10-04
10711234102176Hemochron Whole Blood Coagulation SystemACCRIVA DIAGNOSTICS HOLDINGS, INC.RQCHRT2016-09-22
10711234102183Hemochron Whole Blood Coagulation SystemACCRIVA DIAGNOSTICS HOLDINGS, INC.RQCPRT2016-09-22
10711234102206Hemochron Whole Blood Coagulation SystemACCRIVA DIAGNOSTICS HOLDINGS, INC.QCACT2016-09-22
10711234107027directCHECK Whole Blood ControlsACCRIVA DIAGNOSTICS HOLDINGS, INC.DCJAPTT-N2016-09-22
10711234107034directCHECK Whole Blood ControlsACCRIVA DIAGNOSTICS HOLDINGS, INC.DCJAPTT-A2016-09-22
10711234107041directCHECK Whole Blood ControlsACCRIVA DIAGNOSTICS HOLDINGS, INC.DCJPT-A2016-09-22
10711234107058directCHECK Whole Blood ControlsACCRIVA DIAGNOSTICS HOLDINGS, INC.DCJACT-A2016-09-22
10711234107065directCHECK Whole Blood ControlsACCRIVA DIAGNOSTICS HOLDINGS, INC.DCJCPT-A2016-09-22
10711234107072directCHECK Whole Blood ControlsACCRIVA DIAGNOSTICS HOLDINGS, INC.DCJCPT-N2016-09-22
10711234107089directCHECK Whole Blood ControlsACCRIVA DIAGNOSTICS HOLDINGS, INC.DCJLR-A2016-09-22
10711234107096HepCheck Whole Blood ControlACCRIVA DIAGNOSTICS HOLDINGS, INC.DCP214-N2016-09-22
10711234107102HepCheck Whole Blood ControlACCRIVA DIAGNOSTICS HOLDINGS, INC.DCP214-A2016-09-22
10711234170175directCHECK Whole Blood ControlsACCRIVA DIAGNOSTICS HOLDINGS, INC.DCJCAPTT-A2016-09-22
10711234170229directCHECK Whole Blood ControlsACCRIVA DIAGNOSTICS HOLDINGS, INC.DCJACT-N2016-09-22
10711234170236directCHECK Whole Blood ControlsACCRIVA DIAGNOSTICS HOLDINGS, INC.DCJPT-N2016-09-22
10711234170243directCHECK Whole Blood ControlsACCRIVA DIAGNOSTICS HOLDINGS, INC.DCJLR-N2016-09-22
00815696021297George King Pooled Normal PlasmaGEORGE KING BIO-MEDICAL, INC0010-60.02022-03-03
00815696021303George King Single Donor Normal PlasmaGEORGE KING BIO-MEDICAL, INC0001-60.02022-03-03
00711234170345directCHECK ACT+ Whole Blood Control Level 1ACCRIVA DIAGNOSTICS HOLDINGS, INC.000DCGACT-12022-01-21
00711234170352directCHECK ACT+ Whole Blood Control, Level 2ACCRIVA DIAGNOSTICS HOLDINGS, INC.000DCGACT-22022-01-21
00711234170369directCHECK ACT-LR Whole Blood Controls, Level 1ACCRIVA DIAGNOSTICS HOLDINGS, INC.000DCGLR-12022-01-21
00711234170376directCHECK ACT-LR Whole Blood Control, Level 2ACCRIVA DIAGNOSTICS HOLDINGS, INC.000DCGLR-22022-01-21
03607450006766STA® - Coag Control N + ABNDIAGNOSTICA STAGO006762016-09-15
B55890013020Sonoclot® Reference Viscosity Oil Quality Control KitSIENCO, INC.900-13022021-07-19
B55890013181Sonoclot® Reference Plasma Quality Control KitSIENCO, INC.900-13182021-07-19
08426950071068HemosIL Normal Control ASSAYEDINSTRUMENTATION LABORATORY COMPANY000200031102016-09-23
08426950088646GEM Check Coag Control-Abnormal for ACT-LRINSTRUMENTATION LABORATORY COMPANY062600602002016-09-23
08426950088653GEM Check Coag Control-Abnormal for ACTINSTRUMENTATION LABORATORY COMPANY062600603002016-09-23
08426950452683GEM Check Coag Control-Normal for Citrate PTINSTRUMENTATION LABORATORY COMPANY062600611002016-09-23
08426950452713GEM Check Coag Control-Abnormal for Citrate PTINSTRUMENTATION LABORATORY COMPANY062600614002016-09-23
08426950452744GEM Check Coag Control-Normal for ACTINSTRUMENTATION LABORATORY COMPANY062600605002016-09-23
08426950452751GEM Check Coag Control-Normal for ACT-LRINSTRUMENTATION LABORATORY COMPANY062600606002016-09-23
08426950573401HemosIL Routine Control Level 3INSTRUMENTATION LABORATORY COMPANY000200058002016-09-23
08426950660668HemosIL Abnormal Control 2INSTRUMENTATION LABORATORY COMPANY000200140002016-09-23
08426950078982HemosIL Low Abnormal Control ASSAYEDINSTRUMENTATION LABORATORY COMPANY000200032102016-09-23
08426950078999HemosIL High Abnormal Control ASSAYEDINSTRUMENTATION LABORATORY COMPANY000200033102016-09-23
08426950088639GEM Check Coag Control-Abnormal for APTTINSTRUMENTATION LABORATORY COMPANY062600601002016-09-23
08426950088912Coatest APCR Control Plasma Level 1INSTRUMENTATION LABORATORY COMPANY82 2650 632016-09-23
08426950088929Coatest APCR Control Plasma Level 2INSTRUMENTATION LABORATORY COMPANY82 2668 632016-09-23
08426950442189HemosIL Special Test Control Level 2INSTRUMENTATION LABORATORY COMPANY000200120002016-09-23
08426950452690GEM Check Coag Control-Normal for APTTINSTRUMENTATION LABORATORY COMPANY062600616002016-09-23
08426950452706GEM Check Coag Control-Abnormal for PTINSTRUMENTATION LABORATORY COMPANY062600617002016-09-23
08426950452737GEM Check Coag Control-Normal for PTINSTRUMENTATION LABORATORY COMPANY062600604002016-09-23
08426950453062HemosIL Special Test Control Level 1INSTRUMENTATION LABORATORY COMPANY000200110002016-09-23
08426950573388HemosIL Routine Control Level 1INSTRUMENTATION LABORATORY COMPANY000200056002016-09-23
08426950573395HemosIL Routine Control Level 2INSTRUMENTATION LABORATORY COMPANY000200057002016-09-23
08426950660651HemosIL Normal Control 1INSTRUMENTATION LABORATORY COMPANY000200139002016-09-23
08426950660675HemosIL Abnormal Control 3INSTRUMENTATION LABORATORY COMPANY000200141002016-09-23
00812747018510Haemonetics TEG 6sHAEMONETICS CORPORATION07-665US2021-06-18
00812747018497Haemonetics TEG 6sHAEMONETICS CORPORATION07-664-US2021-06-17
03607450006773STA® - Coag Control (N + ABN) PLUSDIAGNOSTICA STAGO006772016-09-15
03607450006780STA® - System Control N + PDIAGNOSTICA STAGO006782016-09-15