Zhejiang Orient Gene Biotech (688298.SH) has obtained a medical device registration certificate.

Zhejiang Orient Gene Biotech (688298.SH) announced that the company and its wholly-owned subsidiary, Healgen Scientific LLC (referred to as "Healgen"), have recently obtained partial medical device product registration certificates. Its holding subsidiary, Beijing Emerging Four Continents Biotechnology Co., Ltd. (referred to as "Beijing Emerging Four Continents"), has completed the renewal of the Stan virus antibody detection test reagent. The IgM antibody detection test kit for the Stan virus (colloidal gold method) of its holding subsidiary, Beijing Emerging Four Continents, has completed the renewal procedures. The company's Class III medical device registration certificate issued by the China NMPA is valid until 2031, mainly used for early identification and diagnosis of antibodies for diseases, which can help in the rapid identification of Stan virus infections. The evidence collection of the companys other products in countries and regions such as Ethiopia, Saudi Arabia, and Brazil further enriches and improves the layout of the company's time-resolved fluorescence immunochromatography products in the aforementioned countries and regions, as well as expands the sales areas of related products. This is beneficial for the overall expansion of the domestic and international market for time-resolved fluorescence immunochromatography products.