Fact Sheet for Healthcare Providers: Assure COVID-19 IgG/IgM Rapid Test Device - Assure Tech. (Hangzhou Co., Ltd) [open pdf - 81KB]
From the Document: "This Fact Sheet informs you of the significant known and potential risks and benefits of the emergency use of the Assure COVID-19 [coronavirus disease 2019] IgG/IgM [Immunoglobulin G/Immunoglobulin M] Rapid Test Device. Assure COVID-19 IgG/IgM Rapid Test Device is authorized for the detection of IgG and IgM antibodies to SARS-CoV-2 [severe acute respiratory syndrome coronavirus 2] in human venous whole blood (sodium EDTA [ethylenediaminetetraacetic acid]), serum, or plasma (sodium EDTA)."
U.S. Food and Drug Administration: https://www.fda.gov/