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

PUBT · 1d ago
Co-Diagnostics submits FDA 510(k) filing for Flu A/B and RSV point-of-care test
  • 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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