www.fdanews.com/articles/198447-fda-authorizes-velas-covid-19-pcr-test-for-emergency-use
FDA Authorizes Vela’s COVID-19 PCR Test for Emergency Use
August 10, 2020
The FDA has granted Vela Diagnostics an Emergency Use Authorization for a manual version of its coronavirus polymerase chain reaction (PCR) test.
The agency has authorized the ViroKey SARS-CoV-2 RT-PCR diagnostic for use on ABI 7500 Fast Dx instruments in qualified laboratories. It works by detecting the genetic code of the coronavirus.
The test has also earned a CE mark in Europe and a provisional approval in Singapore.