Thrombophilia and coagulation inhibitor IVDs

Intended purpose

IVDs that are intended to be used in testing to provide information about thrombosis or the abnormal development of clots, and inhibitors of the coagulation process. Activated protein C resistance ratio (APCR), activated protein C resistant factor V (factor V Leiden), antithrombin III (ATIII), coagulation factor II inhibitor, coagulation factor IX inhibitor, coagulation factor VII inhibitor, coagulation factor VIII inhibitor, coagulation factor X inhibitor, coagulation factor Xa inhibitor, coagulation factor XI inhibitor, coagulation factor XII inhibitor, coagulation inhibitory substance neutralization, endogenous thrombin potential (ETP), heparin anti-Xa, heparin cofactor II, hirudin, lupus anticoagulant marker, multiple thrombophilia marker, protein C, protein C, protein Z, prothrombin fragment 1 + 2, thrombin-antithrombin III complex (TAT)