Device Category Dossier

CT890 - Immunohaematology calibrator/control IVDs

Device Category Dossier for CT890 - Immunohaematology calibrator/control IVDs. Australian ARTG records, sponsors, device class — compiled by arcimedes.

Immunohaematology calibrator/control in vitro diagnostic devices are quality controls and reference materials intended to establish known points of reference and verify the performance of immunohaematological tests. These devices allow regular control of materials, work procedures and instrument procedures for determination of ABO, Rhesus and K antigens, determination of appropriate ABO blood group antibodies, and detection of irregular antibodies in both antiglobulin and enzyme technique.