10/09/2020 12:00 AM EDT
Source: U.S. Food and Drug Administration (FDA). Published: 10/9/2020. This three-page fact sheet informs healthcare providers of the significant known and potential risks and benefits of the emergency use of the AdviseDx SARS-CoV-2 IgM assay. The AdviseDx SARS-CoV-2 IgM assay is authorized for the qualitative detection of IgM antibodies to SARS-CoV-2 in human serum, serum separator tube, and plasma (dipotassium EDTA, tripotassium EDTA, lithium heparin, lithium heparin separator tube, sodium heparin). (PDF)
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