Dual 510(k) clearance and CLIA-waiver approval for the BIOFIRE® SPOTFIRE® R/ST Panel
Dual 510(k) clearance and CLIA-waiver approval for the BIOFIRE® SPOTFIRE® R/ST Panel
bioMérieux announces nomination of two new Executive Committee members to lead Medical Affairs and R&D
bioMérieux announces nomination of two new Executive Committee members to lead Medical Affairs and R&D
bioMérieux acquires LUMED to reinforce its software portfolio in the fight against antimicrobial resistance
bioMérieux acquires LUMED to reinforce its software portfolio in the fight against antimicrobial resistance
Why Antimicrobial Resistance Is Top of bioMérieux’s Diagnostic List
CLP Magazine recently interviewed Kristen Smith, senior medical science liaison at bioMérieux
bioMérieux submits Dual 510(k) and CLIA-waiver application to FDA for the BIOFIRE® SPOTFIRE® Respiratory/Sore Throat (R/ST) Panel
Marcy-l’Étoile (France), September 22nd, 2023 – 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 (IVDD2).
US FDA 510(k) Clearance and CLIA-waiver for the fast and innovative BIOFIRE® SPOTFIRE® System and its BIOFIRE® SPOTFIRE® Respiratory (R) Panel
US FDA 510(k) Clearance and CLIA-waiver for the fast and innovative BIOFIRE® SPOTFIRE® System
bioMérieux receives FDA Clearance for NEPHROCHECK® test on VIDAS®
bioMérieux receives FDA Clearance for NEPHROCHECK® test on VIDAS®
bioMérieux receives De Novo FDA Authorization for its BIOFIRE® Joint Infection (JI) Panel
Marcy l’Étoile, France – bioMérieux, a world leader in the field of in vitro diagnostics, today announces that its BIOFIRE® Joint Infection (JI) Panel has received De Novo authorization from the US Food and Drug Administration (FDA). This panel tests for 31 pathogens implicated in most acute joint infections, and also includes 8 antimicrobial resistance (AMR) […]
BioMérieux Joint Infection Panel Gets FDA De Novo Authorization
BioMérieux said on Wednesday that its BioFire Joint Infection (JI) Panel has received de novo authorization from the US Food and Drug Administration.
Biomerieux (BioFire) See Strong Q3 Growth
Biomerieux, which includes US-based BioFire, announced Q3 sales growth at 11.6%, significantly above expectations due, in part, to a strong upturn in US respiratory panels demand.
