Co-Diagnostics submits FDA 510(k) filing for Flu A/B and RSV point-of-care test
Reuters2026/08/06 13:32- 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.
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