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

For use in the molecular determination of gene variants responsible for expression of erythrocyte antigen phenotypes in multiple blood group systems.

Functional description

Molecular assays that test for a wide range of allelic variants affecting red blood cell antigen expression in multiple blood group systems via multiplex Polymerase Chain Reaction (PCR).

TGA Public Summary