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06/27/2022: Lab Alert: FDA Revokes EUAs for Two SARS-CoV-2 Tests
Audience: Individuals Performing COVID-19 Testing
Level: Laboratory Alert
On May 10, 2022, the U.S. Food and Drug Administration (FDA) revoked the Emergency Use Authorizations (EUAs) for two SARS-CoV-2 tests:
- The Simoa Semi-Quantitative SARS-CoV-2 IgG Antibody Test
- The Simoa SARS-CoV-2 N Protein Antigen Test
FDA revoked these EUAs under the Federal Food, Drug, and Cosmetic Act. Visit this page for more information about the revocations.
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The Laboratory Outreach Communication System
Laboratory Outreach Communication System (LOCS) | Division of Laboratory Systems (DLS)
Center for Surveillance, Epidemiology, and Laboratory Services (CSELS)
Centers for Disease Control and Prevention (CDC)