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FDA Issues Emergency Use Authorization for PerkinElmer's Euroimmun SARS-CoV-2 Test

NEW YORK – The US Food and Drug Administration on Monday issued Emergency Use Authorization to Euroimmun's EuroRealTime SARS-CoV-2 molecular assay COVID-19.

The PCR-based test is for the qualitative detection of nucleic acid from SARS-CoV-2 in upper respiratory specimens, including nasal, nasopharyngeal, mid-turbinate, and oropharyngeal swabs, as well as bronchioalveolar lavage from patients who are suspected of having COVID-19.

The test, which also has the CE mark, is the second from Euroimmun, a subsidiary of PerkinElmer, to receive EUA from the FDA. In early May, the Lübeck, Germany-based firm's US subsidiary's IgG antibody test was granted EUA. 

PerkinElmer's RT-PCR test for the coronavirus also was granted EUA in March.