Co-Diagnostics completes studies ahead of planned Q3 2026 FDA filing for Flu/RSV point-of-care PCR test

Co-Diagnostics, Inc.

Co-Diagnostics, Inc.

CODX

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  • Co-Diagnostics completed clinical and analytical studies for its Co-Dx PCR Flu A/B & RSV point-of-care test ahead of an FDA 510(k) filing.
  • Targets a dual 510(k) submission with a CLIA Waiver by Application in Q3 2026 for use in waived point-of-care settings.
  • Clinical program enrolled more than 1,400 symptomatic patients across nine US sites; analytical work included over 10,000 test cup runs.


Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Co-Diagnostics Inc. published the original content used to generate this news brief via PR Newswire (Ref. ID: 202607010900PR_NEWS_USPR_____LA95863) on July 01, 2026, and is solely responsible for the information contained therein.

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