Vela Diagnostics’ ViroKey SARS-CoV-2 RT-PCR Test Receives the US FDA’s Emergency Use Authorization

August 7, 2020 Auto Bot Emergency Use Authorization, FDA, Latest, MedTech, receives, SARS-CoV-2 0

Shots:

  • The US FDA has granted EUA to the Vela’s PCR test that detects SARS-CoV-2 in nasopharyngeal and oropharyngeal swabs
  • The manual version of the ViroKey enables flexible sample processing and quick adoption of the test by laboratories with existing ABI 7500 Fast Dx instruments but for high throughput testing, an automated version of the assay is used for the optimization  of a workflow consisting of the Sentosa SX101 instrument, in conjunction with ABI 7500 Fast Dx PCR instrument or the Sentosa SA201 instrument
  • ViroKey SARS-CoV-2 RT-PCR Test has also received the CE mark and provisional approval from the Singapore Health Sciences Authority

Click here ­to­ read full press release/ article | Ref: Vela Diagnostic | Image: Biospectrum Asia