Co-Diagnostics Submits FDA 510(k) Premarket Notification for Upper Respiratory Point-of-Care Test
Co-Diagnostics (Nasdaq: CODX) said 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. The filing follows clinical studies of 1,400 symptomatic patients and analytical work across 27 studies and 10,000+ PCR runs. If granted, the CLIA waiver would enable decentralized point-of-care use; the platform is not yet for sale.





