Device Dossier
Reagent red blood cell IVDs
Device Dossier for Reagent red blood cell IVDs (CT886 - Reagent red blood cell IVDs, Class 4, sponsor Bio-Rad Laboratories). ARTG record, intended…
- GMDN category: CT886 - Reagent red blood cell IVDs
Intended purpose
Specifically characterised reagent red blood cells that are intended to be used in immunohaematological testing due to the known specificity of their red cell antigens.
Functional description
Reagent red cells are human red blood cells diluted to either 3% or 0.8% and are used to identify patient antibodies to red cell antigens.The reagent red cells have known red cells antigens that allow for the identification of unknown patient antibodies.