Letter of Authorization: Omni COVID-19 Assay by RT-PCR | NLM

Disaster Information Management Research Center | NLM

Letter of Authorization: Omni COVID-19 Assay by RT-PCR

06/17/2020 12:00 AM EDT

Source: U.S. Food and Drug Administration (FDA). Published: 6/17/2020. This seven-page letter details the Emergency Use Authorization (EUA) for the Omni COVID-19 Assay by RT-PCR for qualitative detection of nucleic acid from SARS-CoV-2 in nasopharyngeal swab, oropharyngeal swab, anterior nasal swab, mid-turbinate nasal swab, nasopharyngeal wash/aspirate, nasal aspirate, and bronchoalveolar lavage specimens from individuals suspected of COVID-19 by their healthcare provider. (PDF)