BioMerieux files dual FDA 510(k)/CLIA waiver application for BioFire SpotFire Vaginitis Panel

Bioceres Crop Solutions Corp.

Bioceres Crop Solutions Corp.

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  • BioMérieux filed a dual 510(k) and CLIA waiver application with the FDA for its BIOFIRE SPOTFIRE Vaginitis Panel.
  • The company is seeking clearance to market a point-of-care multiplex PCR test designed to deliver vaginitis results in about 20 minutes.
  • BioMérieux also plans a separate EU submission for CE marking under the IVDR as a Class C near-patient test.


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