Device Dossier
Multiple-viruses IVDs
Device Dossier for Multiple-viruses IVDs (CT702 - Multiple-viruses IVDs, Class 3, sponsor Hologic (Australia & New Zealand)). ARTG record, intended…
- GMDN category: CT702 - Multiple-viruses IVDs
Intended purpose
The Panther Fusion SARS-CoV-2/Flu A/B/RSV assay is a multiplex real-time PCR (RT-PCR) in vitro diagnostic test for the rapid and qualitative detection and differentiation of SARS-CoV-2, influenza A virus, influenza B virus, and respiratory syncytial virus (RSV). Nucleic acids are isolated and purified from nasopharyngeal (NP) swab specimens and nasal swab specimens obtained from individuals exhibiting signs and symptoms of a respiratory tract infection.