Co-Diagnostics Submits FDA 510(k) Premarket Notification for Upper Respiratory Point-of-Care Test
Co-Diagnostics announced it submitted a Dual 510(k) premarket notification, with a concurrent CLIA Waiver by Application, to the FDA for its Co-Dx PCR Flu A/B & RSV upper respiratory multiplex test on the Co-Dx PCR Pro instrument for point-of-care use. The submission follows the previously announced completion of the clinical and analytical performance studies supporting the test.
Why it matters — This regulatory submission moves Co-Diagnostics' point-of-care respiratory multiplex test a step closer to potential FDA clearance, which could expand its product portfolio into decentralized testing settings.