FDA grants EUA for BD's COVID-19, flu assay

2019 08 20 21 56 4986 Becton Aacc 2019 400

The U.S. Food and Drug Administration (FDA) has granted Becton Dickinson (BD) an emergency use authorization (EUA) for a new molecular diagnostic test for both SARS-CoV-2 and influenza A and B that can return results in two to three hours. BD's new test also has the CE Mark.

The EUA has updated information that addresses variants of the SARS-COV-2 virus, including variants from the U.K. and South Africa. However, the ability to detect new variants also applies to the standalone SARS-CoV-2 test for the BD Max system.

The BD SARS-CoV-2/Flu assay runs on the BD Max system and differentiates between SARS-CoV-2 and influenza A and B with a positive or negative result for each virus using a single specimen, the firm said.

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