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 Grifols). ARTG record,…

Intended purpose

Qualitative, PCR and hybridization based genotyping test (reagents and software) for the simultaneous identification of multiple alleles encoding human erythrocyte and platelets antigens in genomic DNA extracted from whole blood specimens collected in EDTA.

Functional description

Qualitative, PCR and hybridization based genotyping test (reagents and software) for the simultaneous identification of multiple alleles encoding human erythrocyte and platelets antigens in genomic DNA extracted from whole blood specimens collected in EDTA.

TGA Public Summary