Co-Diagnostics, Inc. (CODX)

NCM – Real Time Price. Currency in USD

1.51

+0.02 (1.34%)

Market open: Aug 12, 2026, 10:16 AM 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.

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06.08.2026

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

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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

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

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Co-Diagnostics, Inc. (CODX)

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

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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

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