09/02/2020 12:00 AM EDT
Source: U.S. Food and Drug Administration (FDA). Published: 9/2/2020. This three-page fact sheet informs healthcare providers of the significant known and potential risks and benefits of the emergency use of the Bio-Speedy Direct RT-qPCR SARS-CoV-2. The Bio-Speedy Direct RT-qPCR SARS-CoV-2 is authorized for use with respiratory specimens collected from individuals suspected of COVID-19 by their healthcare provider. (PDF)
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