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 analytical studies with >10,000 upper respiratory PCR test runs, plus a multicenter reproducibility study, evaluating performance across multiple operators, sites & instruments
• If cleared, the platform will expand access to real-time PCR diagnostics through a lower-cost, cloud-connected system designed for near-patient testing and localized outbreak monitoring

Ref:  PRnewswire  |  Image: Co-Diagnostics  |  Press Release

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