Fact Sheet for Healthcare Providers: Jiangsu CoWin Biotech Co., Ltd. Novel Coronavirus (SARS-CoV-2) Fast Nucleic Acid Detection Kit (PCR-Fluorescence Probing) [open pdf - 148KB]
From the Document: "This Fact Sheet informs you of the significant known and potential risks and benefits of the emergency use of the Novel Coronavirus (SARS-CoV-2 [severe acute respiratory syndrome coronavirus 2]) Fast Nucleic Acid Detection Kit (PCR [polymerase chain reaction]-Fluorescence Probing). The Novel Coronavirus (SARS-CoV-2) Fast Nucleic Acid Detection Kit (PCR-Fluorescence Probing) is authorized for use with oropharyngeal swab specimens collected from individuals suspected of COVID-19 [coronavirus disease 2019] by their healthcare provider."
U.S. Food and Drug Administration: https://www.fda.gov/