FDAnews
www.fdanews.com/articles/199654-certest-obtains-ce-mark-for-flursvcovid-19-test
CE mark

CerTest Obtains CE Mark for Flu/RSV/COVID-19 Test

October 22, 2020

Zaragoza, Spain-based CerTest Biotec announced that its VIASURE SARS-CoV-2 real time polymerase chain reaction (PCR) test has earned a CE Mark certification.

The test kit, which can simultaneously detect COVID-19, the flu and respiratory syncytial virus (RSV), is run on Becton Dickinson’s BD MAX system, which returns results in two to three hours and can run hundreds of samples daily.

"As we enter flu season, the ability to test for both COVID-19 and flu at the same time will speed diagnosis and, ultimately, treatment,” said Nelson Fernandes, managing director of CerTest Biotec.

The VIASURE SARS-CoV-2 test has not yet been cleared for use in the U.S.

View today's stories