Device Dossier

Clinical chemistry autoimmune IVDs

Device Dossier for Clinical chemistry autoimmune IVDs (CT869 - Clinical chemistry autoimmune IVDs, Class 2, sponsor Diagnostica Stago). ARTG record,…

Intended purpose

Lateral Flow Immunoassay to detect IgG antibodies against PF4/polyanion complexes in human plasma or serum. Used in the aid of diagnosing Heparin Induced Thrombocytopenia Type II (HITs) Used as part of a scoring system to diagnose HITs. It is a screening test for HITs.

TGA Public Summary