05/29/2020 12:00 AM EDT
Source: U.S. Food and Drug Administration (FDA). Published: 5/29/2020. This three-page fact sheet informs healthcare providers of the significant known and potential risks and benefits of the emergency use of the COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma), which received an Emergency Use Authorization from the Food and Drug Administration on May 29, 2020. The COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) is authorized for the detection of IgG and IgM antibodies against SARS-CoV-2 in human serum, plasma (EDTA, lithium heparin, and sodium citrate), or venous whole blood. (PDF)
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