emergency use authorization approved

FDA Gives Emergency Clearance to Roche’s COVID-19/Influenza Test

September 8, 2020

Roche has received an Emergency Use Authorization from the FDA for its SARS-CoV-2 and influenza A&B test.

The diagnostic is used on Roche’s cobas 6800 and 8800 systems and is designed for high-volume testing, providing up to 96 test results in approximately three hours.

The product is the first commercial test for automated high-throughput systems that can identify and differentiate between SARS-CoV-2, influenza A and influenza B using a single sample, according to the company.

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