Meridian resubmitted application to FDA for Emergency Use Authorization for Revogene 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 Revogene 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.

Meridian is a fully integrated life science company that develops, manufactures, markets, and distributes a broad range of innovative diagnostic products. They are dedicated to developing and delivering better solutions that give answers with speed, accuracy, and simplicity that are redefining the possibilities of life from discovery to diagnosis. Through discovery and development, they provide critical life science raw materials used in immunological and molecular tests for human, animal, plant, and environmental applications. Through diagnosis, they provide diagnostic solutions in areas including gastrointestinal and upper respiratory infections and blood lead level testing.

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Source: Meridian Bioscience
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