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BIOFIRE^® Respiratory 2.1 (RP2.1) Panel with SARS-CoV-2 obtains De Novo FDA Authorization

This panel allows for the detection of 22 viral and bacterial pathogens responsible for respiratory infections, including SARS-CoV-2 (the cause of COVID-19 disease). The panel is the first SARS-CoV-2 diagnostic test of any kind that has been granted De Novo status by U.S. FDA, having gone...