Fact Sheet for Healthcare Providers: Vela Operations Singapore Pte. Ltd., Virokey SARS-CoV-2 RT-PCR Test v2.0 [open pdf - 156KB]
From the Document: "This Fact Sheet informs you of the significant known and potential risks and benefits of the emergency use of the ViroKey SARS-CoV-2 [severe acute respiratory syndrome coronavirus 2] RT-PCR [reverse transcription polymerase chain reaction] Test v2.0. The ViroKey SARS-CoV-2 RT-PCR Test v2.0 is authorized for use with respiratory 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/