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…

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.

TGA Public Summary