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BD gets EUA, CE mark for combo SARS-CoV-2, flu A+B test

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Feb. 19, 2021–BD announced FDA emergency use authorization for its BD SARS-CoV-2/Flu assay, a molecular diagnostic test for SARS-CoV-2 and influenza A and B that can return results in two to three hours. The test also has been CE marked to the IVD directive.

The assay runs on the BD Max system and distinguishes between SARS-CoV-2 and influenza A and B, providing a positive or negative result for each virus using a single specimen. The EUA includes updated information in the test’s instructions for use that addresses variants of the SARS-COV-2 virus, including variants from the U.K. and South Africa.

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