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September 22, 2023

bioMérieux submits Dual 510(k) and CLIA-waiver application to FDA for the BIOFIRE® SPOTFIRE® Respiratory/Sore Throat (R/ST) Panel

bioMérieux, a world leader in the field of in vitro diagnostics, has submitted the BIOFIRE® SPOTFIRE® Respiratory/Sore Throat (R/ST) Panel to U.S. Food and Drug Administration (FDA) for a dual 510(k) clearance and CLIA1-waiver. This panel is already CE-marked (IVDD).

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Olivier Rescanière

Phone: (+33) (0)4 78 87 20 00 
Email: media@biomerieux.com

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Romain Duchez

Phone: (+33) (0)4 78 87 20 00 
Email: media@biomerieux.com


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