No, this test is available under EUA (Emergency Use Authorization). This test has been validated and the FDA has been notified. This test has not been approved by the FDA. Novir is providing serology testing based on tests from various manufacturers. Such tests have either received an emergency use authorization (EUA) from the U.S. Food and Drug Administration (FDA) or were released for use under FDA guidance, “Policy for Diagnostic Tests for Coronavirus Disease-2019 during the Public Health Emergency – Immediately in Effect Guidance for Clinical Laboratories, Commercial Manufacturers and Food and Drug Administration Staff” that was updated on May 4, 2020. Tests being performed under a EUA have not been FDA cleared or approved and
Novir has completed the independent validation of these tests.