Zhejiang Orient Gene Biotech (688298.SH) and its subsidiaries have obtained multiple medical device registration certificates.

Zhejiang Orient Gene Biotech (688298.SH) announced that the company and its wholly-owned subsidiary Shanghai Wanzijian Biotechnology Co., Ltd. (referred to as "Shanghai Wanzijian Bio") have recently obtained several medical device product registration certificates. The company's treponema antibody detection reagent (colloidal gold method) and Shanghai Wanzijian Bio's human papillomavirus nucleic acid typing (18 types) detection kit (PCR-flow fluorescence hybridization method) have received Class III medical device registration certificates from China's NMPA. These products are suitable for in vitro qualitative detection of treponema antibodies and HPV viruses, further enriching and improving the company's product portfolio in the domestic infectious disease testing field. The certification of fluorescence immunoassay products in the EU, Malaysia, and Indonesia further enhances the overall layout of fluorescence immunoassay products in overseas markets.