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 each EUA.Īuthorized EUA devices in the table below for SARS-CoV-2 antigen diagnostic tests are assigned the QKP product code. more likely to continue to perform as labeled as new variants emerge.designed to detect more than one section of the proteins that make up SARS-CoV-2.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 antigen target, currently either a section of the spike protein or a section of the nucleocapsid protein.Tests with "single target" in the attribute column are: For a list of all antigen SARS-CoV-2 diagnostic tests that have been cleared or granted de novo classification, see devices with product code QVF in FDA’s medical devices databases for 510(k) and De Novo.In addition to COVID-19 tests issued EUAs, there are antigen SARS-CoV-2 diagnostic tests that have been authorized through traditional premarket review pathways. 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home collection tests) or "OTC" (for over-the-counter at-home tests).įor information on test EUAs that have been revoked see Historical Information about Device Emergency Use Authorizations: In Vitro Diagnostics (IVD). 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 antigen diagnostic tests that have been authorized individually. Individual EUAs for Antigen Diagnostic Tests for SARS-CoV-2 Antigen EUA Revisions for Serial (Repeat) Testing.Individual EUAs for Antigen Diagnostic Tests for SARS-CoV-2.IVDs for Management of COVID-19 Patients.Serology and Other Adaptive Immune Response Tests for SARS-CoV-2.Molecular Diagnostic Tests for SARS-CoV-2.In Vitro Diagnostic EUAs: Overview and Templates
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