Multiple-viruses IVDs

Intended purpose

In vitro diagnostic test for the qualitative detection of novel coronavirus antigens, influenza A & B antigens, RSV antigens, AdV antigens, using the rapid immunochromatographic method as an aid in diagnosis of symptomatic individuals. Point of care test: intended for use with nasopharyngeal swabs at the point of care by trained health professionals. Self-test: intended for use with nasal swabs in the home or other non-laboratory environments by lay persons.