Device typeCoagulation factor Xa inhibitor/heparin activity reagent kit IVD: A collection of reagents intended to be used for the quantitative detection of heparin activity by measuring the ability of heparin to inhibit activated coagulation factor X (factor Xa) and for the qualitative and/or quantitative detection of factor Xa inhibitors, in a clinical specimen. The assay is used to monitor anticoagulation therapy with heparin and/or as an aid to diagnose/determine anticoagulant status during therapy with factor Xa direct inhibitors (e.g., rivaroxaban, apixaban).
FDA categoryAnti-factor Xa activity test system, Apixaban
Device ID00630414640204
Catalog number10873942
MRI safetyLabeling does not contain MRI Safety Information