www.fdanews.com/articles/208226-bd-gets-ce-ivd-mark-for-combination-test-for-covid-19-and-influenza-ab
BD Gets CE-IVD Mark for Combination Test for COVID-19 and Influenza A/B
June 15, 2022
Becton Dickinson has received a CE-IVD mark for its new high-throughput molecular diagnostic combination test for SARS-CoV-2 and Influenza A/B, which runs on the company’s BD COR PX/MX platform.
The BD SARS-CoV-2/Flu assay is a real-time polymerase chain reaction (RT-PCR) test that uses a nasal sample to detect infections in both symptomatic and asymptomatic patients. It can differentiate between SARS-CoV-2, influenza A and/or influenza B infections.
The BD COR platform, which received the FDA’s 510(k) clearance last month, can deliver up to 1,000 sample results in 24 hours.