February 23, 2024

FDA Test

Company : BD (Becton Dickinson and Company)

Military Sponsor: DDDI/COVID-19

Indication & Usage: The BD Respiratory Viral Panel for BD Max System is intended for the simultaneous, qualitative detection and differentiation of nucleic acids from SARS-CoV-2, Influenza A, Influenza B, and Respiratory Syncytial Virus, in nasopharyngeal and anterior nasal swabs in individuals suspected of respiratory viral infection.

FDA Approval, Licensure, or Clearance Date: July 2023

Product Type: Diagnostic

Impact Statement: The BD Respiratory Viral Panel for BD MAX System is a molecular test that detects and distinguishes between SARS-CoV-2, flu A and B, and RSV, which often exhibit similar symptoms, from a single sample. With its standardized workflow and protocols and easy to interpret qualitative readouts, this product provides reliable test results (in labs with medium-throughput requirements after 2 hours of runtime), so that patients suspected of respiratory viral infections can be prescribed the appropriate treatment course within a clinically actionable window.