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bioMérieux: BIOFIRE® Respiratory 2.1 (RP2.1) Panel with SARS-CoV-2 Obtains De Novo FDA Authorization – Business Wire
Regulatory News: bioMérieux (Paris:BIM), a world leader in the field of in vitro diagnostics, today announced that BioFire Diagnostics, its subsidiary
MARCY LÉTOILE, France–(BUSINESS WIRE)–Regulatory News:
bioMérieux (Paris:BIM), a world leader in the field of in vitro diagnostics, today announced that BioFire Diagnostics, its subsidiary specialized in molecular syndromic infectious disease testing, has received U.S. Food and Drug Administration (FDA) De Novo authorization for the BIOFIRE® RP2.1 Panel. This panel allows for the detection of 22 viral and bacterial pathogens responsible for respiratory infections, including SARS-CoV-2 (the cause…
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