Coagulation factor IVDs

Intended purpose

IVDs that are intended to be used for the qualitative and/or quantitative determination of individual clotting factors within the coagulation cascade. Coagulation factor II (prothrombin), coagulation factor IIa (thrombin), coagulation factor IX, coagulation factor prekallikrein/kallikrein, coagulation factor V, coagulation factor VII, coagulation factor VIIa, coagulation factor VIII, coagulation factor VIII: ristocetin cofactor complex activity (FVIII:RCO), coagulation factor VIII-associated antigen, coagulation factor X, coagulation factor XI, coagulation factor XII, coagulation factor XIIa, coagulation factor XIIIa pro-enzyme subunit, coagulation factor XIIIa/factor XIIIs, coagulation factor XIIIs carrier protein sub-unit, fibrinogen assay (factor I), high molecular weight kininogen (HMWK), multiple coagulation factor, von Willebrand factor: collagen binding activity (vWF:CBA), von Willebrand factor: ristocetin cofactor complex activity (vWF:RCO).