Device Dossier
General coagulation IVDs
Device Dossier for General coagulation IVDs (CT871 - General coagulation IVDs, Class 2, sponsor Abacus dx). ARTG record, intended purpose, GMDN category…
- GMDN category: CT871 - General coagulation IVDs
Intended purpose
Intended to be used in clinical laboratories for the measurement and assessment of coagulation‑related parameters in human plasma using automated coagulation analyzers, for example Prothrombin Time (PT) Assay Kit, Activated Partial Thromboplastin Time (APTT) Assay Kit, Thrombin Time (TT) Assay Kit, and Fibrinogen (FIB) Assay Kit.