Device Dossier
Fibrinolysis IVDs
Device Dossier for Fibrinolysis IVDs (CT875 - Fibrinolysis IVDs, Class 2, sponsor Diagnostica Stago). ARTG record, intended purpose, GMDN category —…
- GMDN category: CT875 - Fibrinolysis IVDs
Intended purpose
IVDs that are intended to be used in testing to provide information about fibrinolysis, fibrin degradation products and components involved in the process of clot breakdown. Alpha-2-antiplasmin, aprotinin, D-dimer, fibrinogen degradation product (FDP), plasmin, plasmin-alpha-2-antiplasmin complex (PAP), plasminogen activator inhibitor, plasminogen, soluble fibrin monomer complex, thrombin activating fibrinolysis inhibitor, tissue plasminogen activator, total degradation product (TDP), urokinase plasminogen activator.