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Roche received FDA Emergency Use Authorization for the cobas SARS-CoV-2 & influenza A/B test for use on cobas 6800/8800 systems
On Sept. 3, 2020, Roche announced that the cobas SARS-CoV-2 & Influenza A/B Test for use on the cobas 6800/8800 Systems had received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA).
This test was intended for the simultaneous qualitative detection and differentiation of SARS-CoV-2, Influenza A and Influenza B in patients suspected by their healthcare provider of having respiratory viral infection consistent with COVID-19. Additionally, it was available in markets accepting the CE mark.
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Source: Roche
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