05/18/2020 12:00 AM EDT
Source: U.S. Food and Drug Administration (FDA). Published: 5/18/2020. This three-page fact sheet informs healthcare providers of the significant known and potential risks and benefits of the emergency use of the Lyra Direct SARS-CoV-2 Assay, which received an Emergency Use Authorization from the Food and Drug Administration on May 18, 2020. The Lyra Direct SARS-CoV-2 Assay is authorized for use on respiratory specimens from individuals suspected of COVID-19 by their healthcare provider. (PDF)
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