Device Dossier

Immunohaematology calibrator/control IVDs

Device Dossier for Immunohaematology calibrator/control IVDs (CT890 - Immunohaematology calibrator/control IVDs, Class 4, sponsor Immulab). ARTG record,…

Intended purpose

For quality control use in ABO and RhD blood grouping and antibody detection assays.

Functional description

Designed to control, standardise and validate routine immunhaematology tests. These products are to be tested in parallel with routine patient samples to control and ensure the process is capable of determining the correct ABO RhD Blood Group and detecting and identifying clinically relevant, expected antibodies.

TGA Public Summary