Meridian resubmitted application to FDA for Emergency Use Authorization for Revogeneᆴ SARS-CoV-2 molecular assay

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On Jun. 28, 2021, Meridian Bioscience announced that it had re-submitted its application for Emergency Use Authorization (EUA) to the U.S. Food and Drug Administration (FDA) for the companyメs SARS-CoV-2 molecular diagnostic test on the Revogeneᆴ platform.

On Feb. 22, 2021, Meridian voluntarily withdrew its EUA application in order to conduct additional studies based on guidance from the FDA. Meridian completed the additional studies and re-submitted its EUA application on June 25, 2021.

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Source: Meridian Bioscience
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