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