Rapid lateral flow test code#
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home collection tests) or "OTC" (for over-the-counter at-home tests).įor information on test EUAs that have been revoked see Historical Information about Device Emergency Use Authorizations: In Vitro Diagnostics (IVD).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
Rapid lateral flow test serial#
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