March 27, 2024
Dual 510(k) clearance and CLIA-waiver approval for the BIOFIRE® SPOTFIRE® R/ST Panel
bioMérieux, a world leader in the field of in vitro diagnostics, has received U.S. Food and Drug Administration (FDA) 510(k) clearance and Clinical Laboratory Improvement Amendments (CLIA) waiver approval for the BIOFIRE® SPOTFIRE® Respiratory/Sore Throat (R/ST) Panel.