Device Dossier

Bacterial infectious disease IVDs

Device Dossier for Bacterial infectious disease IVDs (CT353 - Bacterial infectious disease IVDs, Class 2, sponsor National Serology Reference…

Intended purpose

Non assay-specific infectious disease quality control material intended for use with IVDs that detect bacterial DNA/RNA, antigens or antibodies to bacterial infectious organisms in human plasma, serum samples or other samples of human origin

TGA Public Summary