VIVO - Meridian Bioscience corrects prior update on Revogene sars-cov-2 EUA withdrawal
Meridian Bioscience ([[VIVO]] -8.0%) updates its communication regarding the withdrawal of its application for Emergency Use Authorization ((EUA)) with the U.S. FDA for the SARS-CoV-2 molecular diagnostic test on its Revogene platform.The FDA has now clarified that Meridian will not be able to distribute its SARS-CoV-2 molecular diagnostic test on its Revogene platform until the test receives EUA approval from the health regulator.This corrects the company’s prior statement that it would resume shipping the test to customers upon notification of its intent to re-submit an EUA application, Meridian said.
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Meridian Bioscience corrects prior update on Revogene sars-cov-2 EUA withdrawal