Device Dossier
Platelet factor IVDs
Device Dossier for Platelet factor IVDs (CT874 - Platelet factor IVDs, Class 2, sponsor Werfen). ARTG record, intended purpose, GMDN category — compiled…
- GMDN category: CT874 - Platelet factor IVDs
Intended purpose
Intended Use: HemosIL HIT-Ab (PF4-H) is a fully automated enhanced immunoassay for the semi-quantitative detection of total immunoglobulin in human citrated plasma that reacts with Platelet factor 4 (PF4) when complexed to heparin on ACL TOP® Family. Heparin associated antibodies are commonly found in patients with heparin induced thrombocytopenia or thrombosis (HIT).