www.fdanews.com/articles/196866-vela-diagnostics-manual-covid-19-test-gets-ce-mark
Vela Diagnostics’ Manual COVID-19 Test Gets CE Mark
April 29, 2020
Vela Diagnostics has earned a CE mark for a manual version of its ViroKey SARS-CoV-2 polymerase chain-reaction test.
The diagnostic can now be used by laboratories on Applied Biosystems 7500 Fast Dx systems to identify patients with COVID-19. It detects the virus by targeting portions of its genome.
The company has also developed an automated version of the test that is currently going through CE mark certification.