07/06/2020 12:00 AM EDT
Source: U.S. Food and Drug Administration (FDA). Published: 7/6/2020. This three-page fact sheet informs healthcare providers of the significant known and potential risks and benefits of the emergency use of the Assure COVID-19 IgG/IgM Rapid Test Device. The Assure COVID-19 IgG/IgM Rapid Test Device is authorized for the detection of IgG and IgM antibodies to SARS-CoV-2 in human venous whole blood (sodium EDTA), serum, or plasma (sodium EDTA). (PDF)
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