emergency use authorization
FDA Grants Emergency Use Authorization for Northeastern University SARS-CoV-2 Test
The RT-PCR-based test was developed by Northeastern University's Life Sciences Testing Center.
FDA Revises SARS-CoV-2 Test Emergency Use Authorization Requirements to Account for Variants
The agency is requiring test developers to monitor emerging mutations and their potential impact on the performance of authorized SARS-CoV-2 tests.
Updated Cepheid SARS-CoV-2, Flu, RSV Test Nabs FDA EUA
The new version of the multiplex test adds a third gene target for SARS-CoV-2 to detect future viral mutations.
Yale School of Public Health Nabs FDA EUA for COVID-19 At-Home Saliva Collection Kit, Test
The extraction-free SalivaDirect test originally received Emergency Use Authorization from the agency last year.
Mount Sinai, Empire City Laboratories SARS-CoV-2 Tests Get FDA Emergency Use Authorizations
Mount Sinai's test uses self-collected saliva samples, while the two tests from Empire City Laboratories use self-collected anterior nasal swab specimens.
Apr 26, 2021