BD (Becton, Dickinson and Company) (NYSE: BDX), a leading global medical technology company, today announced U.S. Food and Drug Administration (FDA) 510(k) clearance for the BD Respiratory Viral Panel (RVP) for BD MAX™ System, a single molecular diagnostic combination test that identifies and distinguishes SARS-CoV-2, influenza A, influenza B, and Respiratory Syncytial Virus (RSV) in approximately two hours.
Hologic Inc. (Nasdaq: HOLX) announced today that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for the company’s Panther Fusion® SARS-CoV-2/Flu A/B/RSV assay. This assay is a molecular diagnostic test that detects and differentiates four of the most prevalent respiratory viruses that can exhibit similar clinical symptoms: severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), influenza A (flu A), influenza B (flu B) and respiratory syncytial virus (RSV).
Becton Dickinson announced on Wednesday that it has received Emergency Use Authorization from the US Food and Drug Administration for its combination COVID-19, influenza A/B, and respiratory syncytial virus test.
Becton Dickinson has obtained the CE-IVD mark on a combined panel assay to detect SARS-CoV-2, influenza A and B, and respiratory syncytial virus. The assay runs on the firm's BD Max instrument and is now available in countries that recognize the CE mark, the firm said on Thursday.
On Monday, The US Food and Drug Administration issued an Emergency Use Authorization to Laboratory Corporation of America's Seasonal Respiratory Virus RT-PCR DTC test for use without a prescription by individuals with symptoms of COVID-19.
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