Device Dossier

Multiple-viruses IVDs

Device Dossier for Multiple-viruses IVDs (CT702 - Multiple-viruses IVDs, Class 3, sponsor Compliance Management Solutions). ARTG record, intended…

Intended purpose

The Healgen Rapid Check COVID-19/Flu A&B Antigen Test is a lateral flow immunochromatographic assay intended for the qualitative detection and differentiation of influenza A, and influenza B nucleoprotein antigens and SARS-CoV-2 nucleocapsid antigen using self-collected anterior nasal swab samples from individuals aged 14 years or older with symptoms of SARS-CoV-2, influenza A, and influenza B infection; within the first 7 days of symptom onset for SARS-CoV-2 and within the first 4 days of symptom onset for influenza A and influenza B.

TGA Public Summary