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bioMérieux: submits Biofire BCID2 for FDA clearance
(CercleFinance.com) - bioMérieux announces that BioFire Diagnostics, its molecular biology affiliate, has submitted to the US Food and Drug Administration for 510(k) clearance of the BIOFIRE Blood Culture Identification 2 (BCID2) Panel.
The in vitro diagnostic specialist explains that this panel includes several additional pathogens, an expanded list of antimicrobial resistance genes and many revised targets compared to the initial Biofire BCID panel. The new generation of the Biofire BCID panel, which is compatible with the Filmarray 2.0 and Filmarray Torch systems, thus includes 26 bacteria, seven yeasts and 10 antibiotic resistance genes. bioMérieux also plans to register the Biofire BCID2 panel in other countries. Copyright (c) 2020 CercleFinance.com. All rights reserved. |
19/04/2024 18:06
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