FDA.report

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

Related Product Codes

CodeDeviceSpecialtyClassDevices
GGNPlasma, Coagulation ControlHematology2118
GGCControl, Plasma, AbnormalHematology220
JPASystem, Multipurpose For In Vitro Coagulation StudiesHematology214
JBPActivated Whole Blood Clotting TimeHematology211
GIZPlasma, Control, NormalHematology26
KFFAssay, HeparinHematology25
DBTFactor Xiii A, S, Antigen, Antiserum, ControlImmunology14
GKNTimer, Clot, AutomatedHematology24
GNNAntisera, Neutralization, Coxsackievirus A 1-24, B 1-6Microbiology14
OHQMulti-Analyte Controls UnassayedClinical Chemistry14
JJYMulti-Analyte Controls, All Kinds (Assayed)Clinical Chemistry13
GGWTest, Time, Partial ThromboplastinHematology22
GISTest, FibrinogenHematology22
GFTProtamine SulphateHematology21
KQJSystem, Fibrinogen DeterminationHematology21

Representative GUDID Devices

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