BD Gets FDA Clearance For COVID-19, Influenza A/B, RSV Molecular Combination Test

(RTTNews) - Becton, Dickinson and Co. (BDX) a medical technology company, announced on Tuesday that its BD Respiratory Viral Panel for BD MAX System has received FDA 510(k) clearance.

The BD Respiratory Viral Panel for the BD MAX System is a single molecular diagnostic combination test that identifies and distinguishes SARS-CoV-2, influenza A, influenza B, and Respiratory Syncytial Virus in approximately two hours. A single nasal swab or a single nasopharyngeal swab sample is enough to determine if a patient has COVID-19 or flu or RSV.

The test has been available in the U.S. since February through an Emergency Use Authorization (EUA) from FDA.

"The BD Respiratory Viral Panel for BD MAX System was CE marked under the IVD directive 98/79/EC in May of 2022, and now with the 510(k) clearance, BD will discontinue the BD RVP EUA version and replace it with the 510(k) version, with no gaps in availability of the test" the company said in a statement.

BDX closed Monday's trading at $278.62, down 0.61%.