Skip Ribbon Commands
Skip to main content
Skip over global navigation links
U.S. Department of Health and Human Services

Vela Diagnostics USA, Inc. – ViroKey™ SARS-CoV-2RT-PCR Test

Vela Diagnostics USA, Inc.'s ViroKey™ SARS-CoV-2RT-PCR Test is a probe-based reverse transcriptase PCR (RT-PCR) test that includes manual and automatic SARS-CoV-20RT-PCT tests. The automated workflow will allow for medium to high throughputs. Each kit allows up to 200 tests including controls. On the automated platform, up to 46 tests and 2 controls can be processed simultaneously per run.

Emergency Use Authorization

On September 22, 2020, FDA issued an Emergency Use Authorization (EUA) to allow Vela Diagnostics USA, Inc.’s ViroKey™ SARS-CoV-2RT-PCR Test to be used to detect nucleic acid from SARS-CoV-2,

  • This page last reviewed: October 26, 2020