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FDA Permits Marketing of First SARS-CoV-2 Diagnostic Test Using Traditional Premarket Review Process
March 24, 2021The U.S. Food and Drug Administration (FDA) granted marketing authorization of the BioFire Respiratory Panel 2.1 (RP2.1), a diagnostic test for the simultaneous qualitative detection and identification of multiple respiratory viral and ... -
Streck Cell-Free DNA BCT Receives FDA De Novo Clearance
September 18, 2020Streck Cell-Free DNA BCT received U.S. Food and Drug Administration (FDA) De Novo clearance for In Vitro Diagnostic use when paired with the Guardant360 CDx liquid biopsy assay.
Pharma Sources Insight January 2025
