Co-Diagnostics Submits FDA 510(k) Premarket Notification for Upper Respiratory Point-of-Care Test
PR Newswire•06/08/2026•09:30 ET
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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 decentralized point-of-care settings
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