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Home » FDA says 28 serology tests withdrawn or pulled from availability in the U.S.
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FDA says 28 serology tests withdrawn or pulled from availability in the U.S.

May 22, 2020
By Mark McCarty
The U.S. FDA reported that 28 serology tests for antibodies for the SARS-CoV-2 virus either have been withdrawn from the market by the sponsor or delisted by the agency for failure to comply with its notification process for emergency use authorization (EUA). The agency said the list of unavailable tests will be updated over time. For his part, Commissioner Stephen Hahn said the move was undertaken “to ensure that Americans have access to trustworthy tests.”
BioWorld MedTech Regulatory Coronavirus Diagnostics U.S. FDA

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