09/23/2020 12:00 AM EDT
Source: U.S. Food and Drug Administration (FDA). Published: 9/23/2020. This three-page fact sheet informs healthcare providers of the significant known and potential risks and benefits of the emergency use of the Orawell IgM/IgG Rapid Test. The Orawell IgM/IgG Rapid Test is authorized for the detection of antibodies to SARS-CoV-2 in human serum and acid citrate dextrose (ACD) plasma. (PDF)
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