sábado, 27 de junio de 2020

Letter of Authorization: DSL COVID-19 Assay, Diagnostic Solutions Laboratory, LLC | NLM

Disaster Information Management Research Center | NLM

Disaster Information and Emergency Response

06/25/2020 12:00 AM EDT


Source: U.S. Food and Drug Administration (FDA). Published: 6/25/2020. This seven-page letter details the Emergency Use Authorization (EUA) for the DSL COVID-19 Assay for qualitative detection of nucleic acid from SARS-CoV-2 in upper respiratory specimens (such as nasal, mid-turbinate, nasopharyngeal, and oropharyngeal swabs) and bronchioalveolarlavage (BAL) specimens from individuals suspected of COVID-19 by their healthcare provider. (PDF)

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