![]() RT, LAMP, Over the Counter (OTC) Home Testing, Saliva, Screening, Multiple Targets Real-time RT-PCR, Home Collection, Saliva, Multiple Targets SARS-CoV-2 DUCoM-PDL Modified Tetracore Assay Michigan State University laboratories, Department of Medicine Olin Student Health Center Authorized EUAs for Multi-analyte Respiratory Panel Tests are assigned the QLT product code.ĭiagnostic (Most Recent Letter of Authorization) and Date EUA Original Issue more likely to continue to perform well when new variants emerge.ĮUAs for standalone specimen collection devices, including home collection kits which do not include an assay in the EUA, will not have a target designation in the attribute column.Īuthorized Molecular Diagnostic Tests for SARS-CoV-2 are assigned the QJR product code.Īuthorized Home Collection Kits are assigned the QLW product code.designed to detect two or more viral targets, or sections of the SARS-CoV-2 genome.Tests with "multiple targets" in the attribute column are: more susceptible to changes in performance due to viral mutations, meaning they are more likely to fail to detect new variants.designed to detect only one viral target on the SARS-CoV-2 genome. ![]() Tests with "single target" in the attribute column are: For a list of all molecular SARS-CoV-2 diagnostic tests that have been cleared or granted de novo classification, see devices with product codes QOF and QQX in FDA’s medical devices databases for 510(k) and De Novo.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the plus (+) button beside the "Date EUA Issued or Last Updated" for the EUA.įor information on test EUAs that have been revoked see Historical Information about Device Emergency Use Authorizations: In Vitro Diagnostics (IVD).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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