Device Dossier

Influenza virus IVDs

Device Dossier for Influenza virus IVDs (CT732 - Influenza virus IVDs, Class 3, sponsor Aceso Diagnostics). ARTG record, intended purpose, GMDN category…

Intended purpose

The Influenza A+B Rapid Test is a rapid chromatographic immunoassay for the qualitative detection of influenza A and B antigens in human nasal swab and nasopharyngeal swab specimens. For near-patient and laboratory professional in vitro diagnostic use only.

TGA Public Summary