06/19/2020 12:00 AM EDT
Source: U.S. Food and Drug Administration (FDA). Published: 6/19/2020. This three-page fact sheet informs healthcare providers of the significant known and potential risks and benefits of the emergency use of the LYHER Novel Coronavirus (2019-nCoV) IgM/IgG Antibody Combo Test Kit (Colloidal Gold). The LYHER Novel Coronavirus (2019-nCoV) IgM/IgG Antibody Combo Test Kit (Colloidal Gold) is authorized for the detection of IgG and IgM antibodies to SARS-CoV-2 in human serum and plasma (dipotassium-EDTA, lithium-heparin, or sodium-citrate). (PDF)
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