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bioMérieux receives De Novo FDA Authorization for its BIOFIRE® Joint Infection (JI) Panel

04 Mai, 2022

Joint infections (“septic arthritis”) are serious infections involving either native  or prosthetic joints. They are medical emergencies which can occur at all ages, and can lead to functional joint impairment, long-lasting disability, and may even be life-threatening. The number of prosthetic...

z.B. 12/21/2024
z.B. 12/21/2024

bioMérieux submits enhanced BIOFIRE® BCID2 Panel for FDA clearance

14 Januar, 2020

bioMérieux, a world leader in the field of in vitro diagnostics, announces that BioFire Diagnostics, its molecular biology affiliate, has submitted to the Food and Drug Administration for 510(k) clearance of the BIOFIRE® Blood Culture Identification 2 (BCID2) Panel. The BIOFIRE® BCID2 Panel includes several additional pathogens, an expanded list of antimicrobial resistance genes, and many revised targets compared to the existing BIOFIRE® BCID Panel.d about 9,800.

Pioneering Diagnostics