Fluxergy, Irvine, Calif, has obtained CE marking for its one-hour COVID-19 RT-PCR test, for use by healthcare professionals as an in vitro diagnostic (IVD) for the detection of SARS-CoV-2. The CE mark will allow Fluxergy’s innovative testing platform to enter the European Union market and any other markets that accept CE marking as valid regulatory approval.
Fluxergy’s platform is an automated, sample-to-answer testing platform with multimodal capability allowing for a variety of assay types—such as molecular, immunochemistry, chemistry, and cytometry assays—to be run simultaneously on the same cartridge. This will give users the ability to run unique point-of-care panels with the potential ability to do built-in reflex testing, among other capabilities.
For more information, visit Fluxergy.
Featured image: Fluxergy one-hour COVID-19 RT-PCR test (Courtesy: Fluxergy)