Device Dossier
Multiple-viruses IVDs
Device Dossier for Multiple-viruses IVDs (CT702 - Multiple-viruses IVDs, Class 3, sponsor Abbott Australasia Pty Ltd Molecular Division). ARTG record,…
- GMDN category: CT702 - Multiple-viruses IVDs
Intended purpose
The Abbott Resp-4-Plex assay is a multiplex real-time reverse transcription (RT) polymerase chain reaction (PCR) test intended for the qualitative detection and differentiation of RNA from influenza A virus (flu A), influenza B virus (flu B), Respiratory Syncytial Virus (RSV), and SARS-CoV-2 in nasopharyngeal (NP) swab specimens collected by a healthcare provider, from individuals with signs and symptoms of respiratory tract infection.