Letter of Authorization: SARS-CoV-2 Assay (Biocerna)| NLM

Disaster Information Management Research Center | NLM

Letter of Authorization: SARS-CoV-2 Assay (Biocerna)

04/28/2020 12:00 AM EDT

Source: U.S. Food and Drug Administration (FDA). Published: 4/28/2020. This one-page letter authorizes the emergency use of the Biocerna SARS-CoV-2 Assay, which is eligible for authorization under the March 31, 2020, Emergency Use Authorization (EUA) for Molecular-based Laboratory Developed Tests for Detection of Nucleic Acid from SARS-CoV-2 (Molecular LDT COVID-19 Authorized Test). (PDF)