www.fdanews.com/articles/198364-yourgenes-sars-cov-2-test-obtains-ce-mark
Yourgene’s SARS-CoV-2 Test Obtains CE Mark
August 5, 2020
UK-based Yourgene Health has earned a CE mark for its Clarigene SARS-CoV-2 in vitro diagnostic kit.
The assay looks for two viral RNA targets which are exclusive to the SARS-CoV-2 virus that causes COVID-19 infections.
The diagnostic kit also includes an internal control to identify when samples are of poor quality and may give invalid results.