Co-Diagnostics Submits FDA 510(k) and CLIA Waiver Applications for Point-of-Care PCR Flu A/B & RSV Test

Shots: Co-Diagnostics submitted a Dual FDA 510(k) premarket notification with a concurrent CLIA Waiver application for its Co-Dx PCR Flu A/B & RSV upper respiratory multiplex test on the Co-Dx PCR Pro platform Submission was backed by clinical & analytical performance studies, incl. study of over 1,400 symptomatic pts across 9 US sites, & 27…