Device Dossier

Immunohaematology sensitised cell-typing IVDs

Device Dossier for Immunohaematology sensitised cell-typing IVDs (CT888 - Immunohaematology sensitised cell-typing IVDs, Class 3, sponsor Haemokinesis).…

Intended purpose

Gel card intended to be used for determining irregular anti-erythrocytic antibodies. Used to detect the presence of IgG antibodies and/or complement bound to the surface of red cells. This may be due to in-vivo (direct antiglobulin test - DAT) or in-vitro (indirect antiglobulin test - IAT) sensitization.

TGA Public Summary