General coagulation IVDs

Intended purpose

An IVD reagent for the quantitative determination of Activated clotting time (ACT), activated partial thromboplastin time (APTT), fibrinogen assay (factor I), prothrombin time (PT), reptilase time or thrombin time (TT) as aid in the diagnosis of fibrinogen related hemostasis disorders in patients with signs or at risk of bleeding disorders in human sodium citrated plasma by means of automated, semi-automated and/or manual coagulometric methods.