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Home » Business, Policy & Funding » Regulatory News & FDA Approvals » FDA Issues Emergency Use Authorization for Roche SARS-CoV-2 Test

FDA Issues Emergency Use Authorization for Roche SARS-CoV-2 Test

Mar 13, 2020
|
staff reporter

NEW YORK – Roche said on Friday that the US Food and Drug Administration has issued Emergency Use Authorization for the Cobas SARS-CoV-2 Test.

The test, which is also CE-IVD marked, is for patients who show signs and symptoms of the disease COVID-19, caused by the SARS-C0V-2 coronavirus. It is for the qualitative detection of SARS-CoV-2 in nasopharyngeal and oropharyngeal swab samples from patients who meet the clinical and epidemiological criteria for testing, and can be used with Roche's fully automated Cobas 6800 and Cobas 8800 systems.

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