Device Dossier

Multiple blood grouping and typing IVDs

Device Dossier for Multiple blood grouping and typing IVDs (CT753 - Multiple blood grouping and typing IVDs, Class 4, sponsor Immulab). ARTG record,…

Intended purpose

Blood grouping reagent that detects the C (RH2), D (RH1) and D (RH1)(weak D) and E (RH3) antigens on human erythrocytes.

Functional description

This reagent will cause agglutination of red cells carrying C, D and/or E antigens using the recommended manual methods or an automated analyser.

TGA Public Summary