www.fdanews.com/articles/196972-neumodx-grabs-ce-mark-for-covid-19-pcr-diagnostic
NeuMoDx Grabs CE Mark for COVID-19 PCR Diagnostic
May 6, 2020
Molecular diagnostic company NeuMoDx has received a CE mark for its SARS-CoV-2 polymerase chain reaction (PCR) assay.
The test is used on the company’s automated, high-throughput euMoDx 288 and 96 systems, and is designed to give results in 80 minutes.
The assay can directly detect coronavirus RNA from nasopharyngeal and oropharyngeal samples and nasal swabs.