bioMérieux acquires LUMED to reinforce its software portfolio in the fight against antimicrobial resistance

CLP Magazine recently interviewed Kristen Smith, senior medical science liaison at bioMérieux

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

bioMérieux receives FDA Clearance for NEPHROCHECK® test on VIDAS®

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 said on Wednesday that its BioFire Joint Infection (JI) Panel has received de novo authorization from the US Food and Drug Administration.