www.fdanews.com/articles/197910-fda-issues-emergency-use-authorization-for-centogenes-covid-19-assay
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FDA Issues Emergency Use Authorization for Centogene’s COVID-19 Assay
July 6, 2020
The FDA has issued an Emergency Use Authorization to Centogene for the company’s new SARS-CoV-2 polymerase chain reaction (PCR) test for detection of the COVID-19 coronavirus.
The reverse-transcription PCR assay uses upper respiratory tract samples from potential or confirmed COVID-19 patients.
The test is intended for use by qualified laboratory personnel in the company’s high-complexity laboratories in Germany.