07/13/2020 12:00 AM EDT
Source: U.S. Food and Drug Administration (FDA). Published: 7/13/2020. This three-page fact sheet informs healthcare providers of the significant known and potential risks and benefits of the emergency use of the Compass Laboratory Services SARS-CoV2 Assay that has been issued an Emergency Use Authorization (EUA) by the FDA. The Compass Laboratory Services SARS-CoV2 Assay is authorized for use on certain respiratory specimens collected from individuals suspected of COVID-19 by their healthcare provider or self-collected using a home collection kit specified in the test’s labeling. (PDF)
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