Co-Diagnostics, Inc. (CODX)

NCM – Real Time Price. Currency in USD

1.48

-0.01 (-0.45%)

Market open: Aug 12, 2026, 1:11 PM EDT

1.46

-0.03 (-1.99%)

Previous after-hours: Aug 11, 2026, 7:34 PM EDT

06.08.2026

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, 2026 /PRNewswire/ -- Co-Diagnostics, Inc. (Nasdaq: CODX) ("Co-Dx" or "the Company"), a molecular diagnostics company with a unique, patented platform for the development of molecular diagnostic tests, today announced that it has submitted a Dual 510(k) premarket notification, with a concurrent CLIA Waiver by Application, to the U.S. Food and Drug Administration ("FDA") for the Co-Dx™ PCR Flu A/B & RSV upper respiratory multiplex test on the Co-Dx PCR Pro® instrument*. The submission follows the Company's previously announced completion of the clinical and analytical performance studies supporting the test.

Videos

No Data

There is no data to display

Press releases

06.08.2026

Co-Diagnostics, Inc. (CODX)

Get all premium features to the best stock analysis tool

Finranks

Company

Contact us

Follow us

Co-Diagnostics, Inc. (CODX)

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

Videos

No Data

Press releases

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

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

Videos

No Data

Press releases

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

Search stocks

Co-Diagnostics, Inc. (CODX)

Get all premium features to the best stock analysis tool

Finranks

Company

Contact us

Follow us

Co-Diagnostics, Inc. (CODX)

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

Videos

No Data

Press releases

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

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

Videos

No Data

Press releases

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