NEW YORK – Qiagen said on Tuesday that it has received a CE-IVD mark for its Artus SARS-CoV-2 Prep&Amp UM Kit for high-throughput PCR-based COVID-19 testing.
The kit is now commercially available in the EU and other markets accepting the CE-IVD mark, and Qiagen has submitted an Emergency Use Authorization application for the assay to the US Food and Drug Administration.