GlobalData on MSN

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

The molecular diagnostics company's concurrent CLIA Waiver by Application, if granted, would allow testing in decentralised point-of-care settings.
TMCnet

Co-Diagnostics Submits FDA 510(k) Premarket Notification for Upper Respiratory Point-of-Care Test

Submission includes a concurrent CLIA Waiver by Application for use of the test on the Co-Dx PCR Pro ® instrument in ...