Zhejiang Orient Gene Biotech Co.,Ltd. (688298.SH) Secures Medical Device Registration Certificates

Stock News
05/26

Zhejiang Orient Gene Biotech Co.,Ltd. (688298.SH) has announced that the company and its wholly-owned subsidiary, Healgen Scientific LLC, recently obtained registration certificates for several medical device products. Additionally, the hantavirus antibody detection reagent from its controlled subsidiary, Beijing Emerging Sihuan Biotechnology Co., Ltd., has completed its renewal certification process. Specifically, the Hantavirus IgM Antibody Test Kit (Colloidal Gold Method) from Beijing Emerging Sihuan Biotechnology Co., Ltd. has finished its renewal formalities. The company's Class III medical device registration certificate issued by China's NMPA now remains valid until 2031. This product is primarily used for early differential diagnosis of disease antibodies and can assist in the rapid identification of hantavirus infections. The acquisition of certificates for the company's other products in countries and regions such as Ethiopia, Saudi Arabia, and Brazil further enriches and enhances the layout of its time-resolved fluorescence immunochromatographic products in these markets. This development also expands the sales regions for related products, contributing to the overall expansion of the time-resolved fluorescence immunochromatographic product market both domestically and internationally.

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