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 external quality control material intended for use with IVDs that detect antigens, antibodies and/or nucleic acids for bacterial infectious organisms in plasma, serum or other human samples.

TGA Public Summary