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

Co-Diagnostics has filed a Dual 510(k) premarket notification and a CLIA Waiver by Application with the US FDA for its Co-Dx PCR Flu A/B & RSV test, aiming to enable decentralised, point-of-care molecular testing for respiratory infections. The submission follows successful clinical and analytical studies and targets wider access beyond traditional labs.

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