Device Dossier

Immunohaematology blood grouping antisera IVDs

Device Dossier for Immunohaematology blood grouping antisera IVDs (CT887 - Immunohaematology blood grouping antisera IVDs, Class 4, sponsor Immulab).…

Intended purpose

Blood grouping reagent used to detect erythrocyte antigen on human red blood cells.

Functional description

The reagent is used to detect erythrocyte antigen on human red blood cells. Agglutination of the red blood cells with the reagent indicates the presence of the respective antigens on the red blood cells. Absence of agglutination indicates the antigen is not present on the red blood cells.

TGA Public Summary