www.fdanews.com/articles/196409-thermo-fisher-gets-ce-mark-for-coronavirus-test
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Thermo Fisher Gets CE Mark for Coronavirus Test
March 27, 2020
Thermo Fisher’s test for the SARS-CoV-2 coronavirus received CE Mark certification in Europe, currently the epicenter for the COVID-19 outbreak.
The real-time PCR test detects nucleic acid from SARS-CoV-2 using Applied Biosystems’ TaqPath assay system. The test can deliver results within four hours of a sample being received by a laboratory.
The FDA granted the company an emergency use authorization for the test on March 13.