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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 ...
The Conversation

COVID‑19 rapid tests still work against new variants – researchers keep ‘testing the tests,’ and they pass

The question quickly arose whether existing rapid antigen tests could detect newly emerging variants. Using clinical samples obtained from diagnostic labs throughout the U.S. from 2020 to 2023, the ...

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. SALT LAKE CITY, Aug. 6, 2 ...