![FDA, FTC and DOJ Enforcement of Medical Device Regulations FDA, FTC and DOJ Enforcement of Medical Device Regulations](https://www.fdanews.com/ext/resources/Book-Covers-2/BFFDEMDR-COVER.png?height=200&t=1685733565&width=200)
Home » Becton Dickinson’s COVID-19 and Flu Combo Test Gets EUA, CE Mark
Becton Dickinson’s COVID-19 and Flu Combo Test Gets EUA, CE Mark
![BectonDickinson_Logo.gif](https://www.fdanews.com/ext/resources/test/Device_Images4/BectonDickinson_Logo.gif?t=1608170871&width=430)
February 16, 2021
Becton Dickinson has received both FDA Emergency Use Authorization (EUA) and CE mark certification for its molecular diagnostic test for SARS-CoV-2 and influenza A and B.
The BD SARS-CoV-2/Flu assay is run on the company’s BD MAX molecular diagnostic platform and can differentiate between COVID-19 and flu infections using a single sample. The BD MAX system can analyze hundreds of samples in a 24-hour period.
The new test, which BD said can successfully detect the UK and South African coronavirus variants, provides a positive or negative result for both COVID-19 and the flu.
Upcoming Events
-
21Oct