Device Dossier

Viral infectious disease IVDs

Device Dossier for Viral infectious disease IVDs (CT355 - Viral infectious disease IVDs, Class 2, sponsor Becton Dickinson). ARTG record, intended…

Intended purpose

An assay or a test use for the direct and qualitative detection of viral infectious disease antigens such as RSV from nasopharyngeal washes/aspirates and nasopharyngeal swabs in transport media from patients suspected of having a viral respiratory infection.

TGA Public Summary