www.fdanews.com/articles/196318-qiagen-snags-ce-mark-for-coronavirus-diagnostic
Qiagen Snags CE Mark for Coronavirus Diagnostic
March 19, 2020
Qiagen received CE Mark certification for its coronavirus test kit and has launched the in-vitro diagnostic in the European Union.
The QIAstat-Dx Respiratory SARS-CoV-2 panel can differentiate between novel coronavirus and 21 other respiratory infections using a single sample, producing results in about an hour.
The multiplex nucleic acid test targets two genes used for detecting COVID-19 using nasal swab samples from individuals believed to be infected.