CAP TODAY Pathology/Laboratory Medicine/Laboratory Management
September 2023—BD announced FDA 510(k) clearance for its BD Respiratory Viral Panel for the BD Max system. It is a single molecular diagnostic combination test that uses a single nasal or nasopharyngeal swab sample to determine if a patient has SARS-CoV-2, influenza A, influenza B, or respiratory syncytial virus. Results are available in about two hours.
With this clearance of the test, BD will discontinue the EUA version and replace it with the 510(k) version.
BD, 201-847-6800