Device Dossier
Reagent red blood cell IVDs
Device Dossier for Reagent red blood cell IVDs (CT886 - Reagent red blood cell IVDs, Class 4, sponsor Immulab). ARTG record, intended purpose, GMDN…
- GMDN category: CT886 - Reagent red blood cell IVDs
Intended purpose
For use in antibody screening, identification and reverse grouping.
Functional description
Aggluntination and /or haemolysis of the reagent red blood cell, in one or more techniques demonstrates the presence of clinically relevant antibodies in patient serum/ plasma samples.