Meridian provided an update on the Revogeneᆴ SARS-CoV-2 EUA submission
On Feb. 16, 2021, Meridian Bioscience provided an update on its application for Emergency Use Authorization (EUA) with the FDA for the SARS-CoV-2 molecular diagnostic test on its Revogeneᆴ platform.
The Company received further correspondence from the FDA Feb. 12 that requested additional information on the SARS-CoV-2 molecular diagnostic test on its Revogeneᆴ platform. The Company planned to submit a response with additional information to the FDA for its review. The Company had elected to place shipments of the SARS-CoV-2 test kits on hold while it continued to work with the FDA.
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Source: Meridian Bioscience
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