Co-Diagnostics files FDA 510(k) for flu and RSV PCR test

Co-Diagnostics filed a Dual 510(k) premarket notification with the FDA for its Co-Dx PCR Flu A/B & RSV upper respiratory multiplex test. The filing seeks clearance for a molecular diagnostic assay capable of detecting influenza A, influenza B, and respiratory syncytial virus from upper respiratory specimens in a single test.