Device Dossier

Immunohaematology calibrator/control IVDs

Device Dossier for Immunohaematology calibrator/control IVDs (CT890 - Immunohaematology calibrator/control IVDs, Class 4, sponsor Bio-Rad Laboratories).…

Intended purpose

IVDs that are intended to be used in testing to establish known points of reference and/or verify the performance of immunohaematological tests.

Functional description

Controls for the Immunoglobulin qualitative assay for haemagglutination for specific antigens on RBCs.

TGA Public Summary