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