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

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.

TGA Public Summary