www.fdanews.com/articles/198650-opgen-earns-ce-mark-for-covid-19-diagnostic
OpGen Earns CE Mark for COVID-19 Diagnostic
August 21, 2020
Maryland-based OpGen’s German subsidiary Curetis has earned a CE mark for its SARS-CoV-2 diagnostic kit.
The polymerase chain reaction (PCR) test kit includes a lysis-buffer solution for RNA extraction, removing the need for extraction kits and reagents.
The diagnostic runs on real-time PCR detection systems, including Applied Biosystems’ QuantStudio 5 and Bio-Rad’s CFX96.