US FDA News: FDA Permits Marketing of First SARS-CoV-2 Diagnostic Test Using Traditional Premarket Review Process

The FDA grants marketing status to BioFire Diagnostics LLC for its BioFire Respiratory Panel 2.1. This is the first SARS-CoV-2 diagnostic test that the FDA has granted full marketing status to in the U.S. since the start of the public health emergency.
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