Co-Diagnostics submits FDA 510(k) filing for Flu A/B and RSV point-of-care test

Reuters2026/08/06 13:32

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Co-Diagnostics filed a Dual FDA 510(k) premarket notification with a concurrent CLIA Waiver by Application for its Co-Dx PCR Flu A/B RSV test.
The submission covers use on the Co-Dx PCR Pro instrument for decentralized point-of-care settings.

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 on August 06, 2026, and is solely responsible for the information contained therein.

Disclaimer: The content of this article solely reflects the author's opinion and does not represent the platform in any capacity. This article is not intended to serve as a reference for making investment decisions.

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Co-Diagnostics submits FDA 510(k) filing for Flu A/B and RSV point-of-care test

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