www.fdanews.com/articles/198258-bruker-earns-ce-mark-for-pcr-covid-19-test
Bruker Earns CE Mark for PCR COVID-19 Test
July 29, 2020
Bruker’s FluoroType SARS-CoV-2 polymerase chain reaction (PCR) assay has earned a CE Mark in Europe for detection of COVID-19 infections.
The assay detects RNA from the coronavirus from respiratory samples, and it runs on common thermocyclers including the company’s FluoroCycler XT.
The test includes reagents needed to generate up to 96 results in under two hours. It demonstrated 100 percent accuracy in two clinical trials, the company said.