Device Dossier

Multiple-viruses IVDs

Device Dossier for Multiple-viruses IVDs (CT702 - Multiple-viruses IVDs, Class 3, sponsor 2San). ARTG record, intended purpose, GMDN category — compiled…

Intended purpose

Covid-19 & Influenza A|B Pen test: Intended to detect Influenza A/B and the novel coronavirus SARS-CoV-2 from symptomatic individuals for self-testing by lay persons (Nasal swab). Covid-19, Influenza A|B & RSV Pen Test: Intended to detect Influenza A/B, RSV, and the novel coronavirus SARS-CoV-2 from symptomatic individuals for self-testing by laypersons (Nasal swab).

TGA Public Summary