Device Category Dossier

CT732 - Influenza virus IVDs

Device Category Dossier for CT732 - Influenza virus IVDs. Australian ARTG records, sponsors, device class — compiled by arcimedes.

Influenza virus in vitro diagnostic devices are qualitative tests that detect influenza A and/or B virus antigens or RNA in respiratory specimens such as oropharyngeal, nasal, or nasopharyngeal swabs through immunoassay or nucleic acid amplification methods. These devices are used to aid in the diagnosis of influenza A and B viral infections in individuals suspected of influenza .