General coagulation IVDs

Intended purpose

IVDs that are intended to be used in testing to provide information about the general coagulation of blood and the time taken for a clinical blood specimen to clot following initiation of the intrinsic and/or extrinsic coagulation pathways. Includes activated clotting time (ACT), activated partial thromboplastin time (APTT), fibrinogen assay (factor I), prothrombin time (PT), reptilase time, thrombin time (TT).