Device Dossier

Viral infectious disease IVDs

Device Dossier for Viral infectious disease IVDs (CT355 - Viral infectious disease IVDs, Class 2, sponsor Hologic (Australia & New Zealand)). ARTG…

Intended purpose

The Panther Fusion Paraflu/AdV/hMP/RV assays are multiplex real-time PCR (RT-PCR) in-vitro diagnostic tests for the rapid and qualitative detection and differentiation of Adenovirus, human Metapneumovirus, parainfluenza 1 virus, parainfluenza 2 virus, parainfuenza 3 virus and parainfluenza 4 virus. Nucleic acids are isolated from nasopharyngeal swab specimens from individuals exhibiting signs and symptoms of a respiratory tract infections.

TGA Public Summary