7/5/2023 0 Comments Helix diagnostics![]() ![]() In addition to COVID-19 tests issued EUAs, there are molecular SARS-CoV-2 diagnostic tests that have been authorized through traditional premarket review pathways. To see additional authorization documents, such as letters granting EUA amendments or revisions, and a list of other brand names authorized under a specific EUA, select the plus (+) button beside the "Date EUA Issued or Last Updated" for the EUA.įor information on test EUAs that have been revoked see Historical Information about Device Emergency Use Authorizations: In Vitro Diagnostics (IVD). Tests available without a prescription include the attribute "DTC" (for direct-to-consumer home collection tests) or "OTC" (for over-the-counter at-home tests). For example, tests authorized for the screening of asymptomatic individuals without known exposure are listed with "screening" in the attribute column pooling, multi-analyte, saliva, home collection, and home testing are similarly listed. Test attributes are listed in the "Attributes" column. These EUAs have been issued for each individual test with certain conditions of authorization required of the manufacturer and authorized laboratories. This table includes information about authorized SARS-CoV-2 molecular diagnostic tests. Individual EUAs for Molecular Diagnostic Tests for SARS-CoV-2
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