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