FDA.reportPublic FDA data

Multiple coagulation marker 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 multiple makers associated with coagulation including coagulation factors, intermediates and/or their activated components, functional tests [activated partial thromboplastin time (APTT), thrombin time (TT), prothrombin time (PT)] and/or physiological anticoagulants (e.g., antithrombin III) in a clinical specimen.
GUDID devices
64
Last updated
2026-06-04 19:44:10

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00630414639703Control Plasma PSiemens Healthcare Diagnostics Products GmbH108738912024-02-19
00630414640167Dade Ci-Trol Coagulation Control Level 1Siemens Healthcare Diagnostics Products GmbH108738422024-03-25
00630414640259Dade Ci-Trol Heparin Control, LowSiemens Healthcare Diagnostics Products GmbH108738332024-03-25
00630414640280Dade Ci-Trol Coagulation Control Level 2Siemens Healthcare Diagnostics Products GmbH108738432024-03-25
00630414640365Dade Ci-Trol Heparin Control, HighSiemens Healthcare Diagnostics Products GmbH108738342024-03-25
00630414640426Dade Ci-Trol Coagulation Control Level 3Siemens Healthcare Diagnostics Products GmbH108738442024-03-25
00630414640747Control Plasma N Siemens Healthcare Diagnostics Products GmbH108738742024-02-19
00763000558185CLOTtrac™MEDTRONIC, INC.550-012026-02-22
00763000558192CLOTtrac™MEDTRONIC, INC.550-072026-02-22
00763000558208CLOTtrac™MEDTRONIC, INC.550-082026-02-22
00763000558215CLOTtrac™MEDTRONIC, INC.550-092026-02-22
00763000558222CLOTtrac™MEDTRONIC, INC.550-102026-02-22
00763000558239CLOTtrac™MEDTRONIC, INC.550-122026-02-22
03663537008306BIOPHEN NORMAL CONTROL PLASMAHYPHEN BIOMED2232012016-08-25
03663537008313BIOPHEN ABNORMAL CONTROL PLASMAHYPHEN BIOMED2233012016-08-25
04260160470341ROTEM®Tem Innovations GmbHsigma ROTROL N2022-10-04
04260160470358ROTEM®Tem Innovations GmbHsigma ROTROL P2022-10-04
050700024203855-PLASMA Bivalirudin Control5-Diagnostics Ltd5D-449052026-04-02
08718734962724CueSee® CoagEurotrol B.V.12025-04-08
08718734962731CueSee® CoagEurotrol B.V.22025-04-08
08718734962748CueSee® CoagEurotrol B.V.32025-04-08
08718734962755CueSee® CoagEurotrol B.V.42025-04-08
08718734962762CueSee® CoagEurotrol B.V.52025-04-08
10629009031050VisuCon-F Low Fibrinogen Control PlasmaAffinity Biologicals IncLFGCP01052017-04-28
10629009031258VisuCon-F Low Fibrinogen Control PlasmaAffinity Biologicals IncLFGCP01252017-04-28
10629009031814VisuCon-F Low Fibrinogen Control PlasmaAffinity Biologicals IncLFGCP01812017-04-28
10629009051058VisuCon-F Frozen Calibrator PlasmaAffinity Biologicals IncFRNCP01052017-04-28
10629009051256VisuCon-F Frozen Normal Control PlasmaAffinity Biologicals IncFRNCP01252017-04-28
10629009061057VisuCon-F Frozen Abnormal Control PlasmaAffinity Biologicals IncFRABP01052017-04-28
10629009061255VisuCon-F Frozen Abnormal Control PlasmaAffinity Biologicals IncFRABP01252017-04-28
10629009071254VisuCon-F Frozen Coag Screen NAffinity Biologicals IncFCSN01252017-04-28
10629009071810VisuCon-F Frozen Coag Screen NAffinity Biologicals IncFCSN01812017-04-28
10629009074811VisuCon-F Frozen Coag Screen NAffinity Biologicals IncFCSN04812017-04-28
10629009081253VisuCon-F Frozen Coag Screen ABNAffinity Biologicals IncFCSAB01252017-04-28
10629009081819VisuCon-F Frozen Coag Screen ABNAffinity Biologicals IncFCSAB01812017-04-28
10629009084810VisuCon-F Frozen Coag Screen ABNAffinity Biologicals IncFCSAB04812017-04-28
10711234170342directCHECK ACT+ Whole Blood Control Level 1ACCRIVA DIAGNOSTICS HOLDINGS, INC.000DCGACT-12022-01-21
10711234170359directCHECK ACT+ Whole Blood Control, Level 2ACCRIVA DIAGNOSTICS HOLDINGS, INC.000DCGACT-22022-01-21
10711234170366directCHECK ACT-LR Whole Blood Controls, Level 1ACCRIVA DIAGNOSTICS HOLDINGS, INC.000DCGLR-12022-01-21
10711234170373directCHECK ACT-LR Whole Blood Control, Level 2ACCRIVA DIAGNOSTICS HOLDINGS, INC.000DCGLR-22022-01-21
10812747018203TEG5000HAEMONETICS CORPORATION07-0442017-05-30
10812747018210TEG5000HAEMONETICS CORPORATION07-0452017-05-30
10812747018296TEG6s HEMOSTASIS SYSTEMHAEMONETICS CORPORATION07-650-US2017-07-17
10812747018302TEG6s HEMOSTASIS SYSTEMHAEMONETICS CORPORATION07-651-US2017-08-18
10812747018340TEG6S HEMOSTASIS SYSTEMHAEMONETICS CORPORATION07-662US2017-07-17
10859394006061PlasmaCon NR 2 DIAGNOSTICS, INC.30-2012016-11-15
10859394006078PlasmaCon L1R 2 DIAGNOSTICS, INC.31-2012016-11-15
10859394006085PlasmaCon L2R 2 DIAGNOSTICS, INC.32-2012016-11-15
10859394006122PlasmaCon LAR 2 DIAGNOSTICS, INC.150-2002016-11-15
10859394006139PlasmaCon LAR 2 DIAGNOSTICS, INC.150-2012016-11-15
10885074184828CLOTtrac®MEDTRONIC, INC.550-012016-07-17
10885074184873CLOTtrac®MEDTRONIC, INC.550-072016-06-18
10885074184880CLOTtrac®MEDTRONIC, INC.550-082016-06-18
10885074184910CLOTtrac®MEDTRONIC, INC.550-092016-06-18
10885074184927CLOTtrac®MEDTRONIC, INC.550-102016-06-18
20812747018491Haemonetics TEG 6sHAEMONETICS CORPORATION07-664-US2021-06-17
20812747018514Haemonetics TEG 6sHAEMONETICS CORPORATION07-665US2021-06-18
B55890013021Sonoclot® Reference Viscosity Oil Quality Control KitSIENCO, INC.900-13022021-07-19
M52551830AB-Trol 3 Coagulation ControlHELENA LABORATORIES CORPORATION51832016-08-18
M52551850Coagulation S.A.R.P (Specialty Assayed Reference Plasma)HELENA LABORATORIES CORPORATION51852016-09-07
M52551860NORM-TROL 1 Coagulation ControlHELENA LABORATORIES CORPORATION51862016-09-07
M52551870AB-TROL 2 Coagulation ControlHELENA LABORATORIES CORPORATION51872016-09-07
M52553010Coagulation S.A.C.-1 (Specialty Assay Control)HELENA LABORATORIES CORPORATION53012016-09-07
M52553020Coagulation S.A.C.-2 (Specialty Assay Control)HELENA LABORATORIES CORPORATION53022016-09-07