FDA.reportPublic FDA data

Heparin anti-Xa IVD, control

Definition
A material which is used to verify the performance of an assay intended to be used for the quantitative monitoring of heparin anticoagulant therapy by determining its ability to inhibit the activity of activated factor X (factor Xa) in a clinical specimen.
GUDID devices
32
Last updated
2026-06-04 19:44:10

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00630414639840INNOVANCE Heparin UF Control 2Siemens Healthcare Diagnostics Products GmbH108739272024-03-25
00630414639857INNOVANCE Heparin LMW Control 2Siemens Healthcare Diagnostics Products GmbH108739282024-03-25
00630414639949INNOVANCE Heparin UF Control 1Siemens Healthcare Diagnostics Products GmbH108739262024-03-25
00630414639956INNOVANCE Heparin LMW Control 1Siemens Healthcare Diagnostics Products GmbH108739292024-03-25
03663537007989BIOPHEN LMWH Control C3HYPHEN BIOMED2238012016-08-25
03663537007996BIOPHEN UFH CONTROL C2HYPHEN BIOMED2239012016-08-25
03663537008283BIOPHEN LMWH Control PlasmaHYPHEN BIOMED2230012016-08-25
03663537008290BIOPHEN UFH Control PlasmaHYPHEN BIOMED2231012016-08-25
03663537008368BIOPHEN LMWH Control LowHYPHEN BIOMED2237012016-08-25
03663537042904BIOPHEN UFH Control C1HYPHEN BIOMED2241012016-08-25
03663537043505BIOPHEN LMWH CONTROL LOW CIHYPHEN BIOMED2243012016-08-25
03663537043512BIOPHEN LMWH CONTROL LOW CIIHYPHEN BIOMED2244012016-08-25
03663537043550BIOPHEN LMWH Control C4HYPHEN BIOMED2242012016-08-25
00815696021327George King Heparin Control Plasma GEORGE KING BIO-MEDICAL, INC7000-1.02025-07-11
00630414229515INNOVANCE Heparin UF Control 1Siemens Healthcare Diagnostics Products GmbH108739262024-03-25
00630414229522INNOVANCE Heparin UF Control 2Siemens Healthcare Diagnostics Products GmbH108739272024-03-25
00630414229539INNOVANCE Heparin LMW Control 1Siemens Healthcare Diagnostics Products GmbH108739292024-03-25
00630414229546INNOVANCE Heparin LMW Control 2Siemens Healthcare Diagnostics Products GmbH108739282024-03-25
08426950083597Control Plasma LMW HeparinINSTRUMENTATION LABORATORY COMPANY82 3492 632016-09-23
08426950472490HemosIL LMW Heparin ControlsINSTRUMENTATION LABORATORY COMPANY000203002002016-09-23
08426950478683HemosIL UF Heparin ControlsINSTRUMENTATION LABORATORY COMPANY000203003002016-09-23
03607450006827STA® - HBPM/LMWH ControlDIAGNOSTICA STAGO006822016-09-15
03607450003819STA® - Quality HNF/UFHDIAGNOSTICA STAGO003812016-09-15
03607450006865STA® - Quality HBPM/LMWHDIAGNOSTICA STAGO006862016-09-15
03607450006834STA® - Heparin ControlDIAGNOSTICA STAGO006832016-09-15
00842768017070INNOVANCE Heparin UF Control 1Siemens Healthcare Diagnostics Products GmbH108735312017-09-15
00842768017087INNOVANCE Heparin UF Control 2Siemens Healthcare Diagnostics Products GmbH108735322017-09-15
00842768017094INNOVANCE Heparin LMW Control 2Siemens Healthcare Diagnostics Products GmbH108735332017-09-15
00842768017100INNOVANCE Heparin LMW Control 1Siemens Healthcare Diagnostics Products GmbH108735342017-09-15
00859110005098ValidateLgc Clinical Diagnostics, Inc.903il2017-03-21
00859110005104Validate Lgc Clinical Diagnostics, Inc.903st2017-10-30
00859110005111Validate Lgc Clinical Diagnostics, Inc.903se2018-08-06