Home 5 Articles 5 Agency Tells EUA SARS-CoV-2 Test Makers to Account for Viral Mutations

Agency Tells EUA SARS-CoV-2 Test Makers to Account for Viral Mutations

by | Oct 5, 2021

On Sept. 23, FDA issued a letter requiring producers of SARS-CoV-2 tests with Emergency Use Authorization (EUA) to take additional steps to account for viral variants. The new Conditions of Authorization apply to certain molecular, antigen and serology tests that have already received EUA for SARS-CoV-2 diagnosis and detection. They don’t cover EUAs for authorized […]

On Sept. 23, FDA issued a letter requiring producers of SARS-CoV-2 tests with Emergency Use Authorization (EUA) to take additional steps to account for viral variants. The new Conditions of Authorization apply to certain molecular, antigen and serology tests that have already received EUA for SARS-CoV-2 diagnosis and detection. They don’t cover EUAs for authorized […]

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