Device Dossier

Immunohaematology sensitised cell-typing IVDs

Device Dossier for Immunohaematology sensitised cell-typing IVDs (CT888 - Immunohaematology sensitised cell-typing IVDs, Class 2, sponsor Bio-Strategy).…

Intended purpose

Immunoglobulins capable of binding to substances on the surface of sensitised red blood cells that are intended to be used in immunohaematological testing to provide information about the nature of red blood cell sensitisation, including immunoglobulin heavy chain class or complement protein type.

TGA Public Summary