What is the CLIA test complexity categorization of SARS-CoV-2 tests that do not have an Emergency Use Authorization (EUA)?
Tests for SARS-CoV-2 that are offered prior to or without an EUA have not been reviewed by the Food and Drug Administration (FDA), are not FDA-authorized, and have not received a CLIA categorization. Thus, those tests are considered high complexity by default until they receive an EUA or other FDA review that indicates they may be performed as moderate complexity or waived tests. For more information, visit FDA COVID-19 Resources, and navigate to the section titled “General FAQs.”