Co-Diagnostics submits FDA 510(k) for Co-Dx PCR Flu A/B & RSV point-of-care test

Co-Diagnostics has submitted a 510(k) premarket notification to the FDA for its Co-Dx PCR Flu A/B & RSV upper-respiratory multiplex test. The filing pertains to use on the Co-Dx PCR Pro instrument, which is part of the company's point-of-care PCR platform aimed at a potential US launch.

Co-Diagnostics submitted a 510(k) premarket notification to the FDA for its Co-Dx PCR Flu A/B & RSV upper-respiratory multiplex test. * Filing covers use on the Co-Dx PCR Pro instrument, part of its point-of-care PCR platform targeted for a potential US launch. 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: 202608180930PR_NEWS_USPR_____LA28476) on August 18, 2026, and is solely responsible for the information contained therein. © Copyright 2026 - Public Technologies (PUBT)

Co-Diagnostics submits FDA 510(k) for Co-Dx PCR Flu A/B & RSV point-of-care test

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