Device Dossier
Multiple-viruses IVDs
Device Dossier for Multiple-viruses IVDs (CT702 - Multiple-viruses IVDs, Class 3, sponsor Australia Health Products Central). ARTG record, intended…
- GMDN category: CT702 - Multiple-viruses IVDs
Intended purpose
The COVID-19/RSV/ADV/Flu A&B Antigen Combo Rapid Test Kit is a qualitative, lateral flow immunoassay for the detection of SARS-CoV-2, RSV, Adenovirus, Influenza A and Influenza B nucleoproteins viral antigens in nasal swabs, using the rapid immunochromatographic method as an aid in the diagnosis of SARS-CoV-2 ,RSV, Adenovirus, and Influenza infections. This kit is intended for testing samples collected from symptomatic individuals by trained health professionals at the point of care or for layperson's home use in a non-laboratory environment.