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

Disclaimer:This article represents the opinion of the author only. It does not represent the opinion of Webull, nor should it be viewed as an indication that Webull either agrees with or confirms the truthfulness or accuracy of the information. It should not be considered as investment advice from Webull or anyone else, nor should it be used as the basis of any investment decision.
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