Device Category Dossier

CT753 - Multiple blood grouping and typing IVDs

Device Category Dossier for CT753 - Multiple blood grouping and typing IVDs. Australian ARTG records, sponsors, device class — compiled by arcimedes.

Blood grouping reagents are immunoglobulins capable of binding to specific antigenic determinants that are supplied together and intended to be used in testing for a combination of blood group antigens within one or multiple blood group systems. These products are used for serological blood group testing in transfusion medicine and pre-transfusion compatibility assessment.