08/17/2020 12:00 AM EDT
Source: U.S. Food and Drug Administration (FDA). Published: 8/17/2020. This three-page fact sheet informs healthcare providers of the significant known and potential risks and benefits of the emergency use of the Diazyme DZ-Lite SARS-CoV-2 IgM CLIA Kit. The Diazyme DZ-Lite SARS-CoV-2 IgM CLIA Kit is authorized for the detection of antibodies to SARS-CoV-2 in human serum or plasma (potassium EDTA, disodium EDTA and lithium heparin). (PDF)
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