Beroni Group, an international diversified biopharmaceutical enterprise focused on the research, development, innovation and commercialization of therapies and products for treatment of global diseases, is pleased to announce that it has received notification from its European Authorized Representative, CMC Medical Devices & Drugs SL, that its SARS-CoV-2 IgG/IgM Antibody Detection Kit complies with the applicable essential requirements of the European Parliament and of the Council’s directive 98/79/EEC on medical devices as amended.

Beroni’s SARS-CoV-2 IgG/IgM Antibody Detection Kit based on colloidal gold is a rapid single-use immunochromatographic test intended for the qualitative detection of IgG and IgM protein from the SARS-CoV-2 virus in capillary “fingerstick” whole blood, plasma, and serum samples. The point-of-care test kit is intended for professional use and delivers clinical results within 10 minutes.

Jacky Zhang, Chairman and CEO of Beroni Group, said, “With the rapid increase in the number of coronavirus cases globally, the availability of fast and effective test kits is of utmost urgency. We want to make our test kit available in the European Union countries and other markets as soon as possible to combat the exponential growth of the coronavirus infections.”

Source: Company Press Release