幽门螺杆菌抗原检测试剂(粪便)
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东方生物:十余款检测试剂在国内、欧盟获注册证
Cai Jing Wang· 2025-11-18 05:11
Core Viewpoint - Dongfang Bio has recently announced the acquisition of medical device registration certificates for various antigen detection kits, enhancing its product offerings in respiratory disease diagnostics [1] Group 1: Product Registrations - The company and its subsidiary, Hangzhou Laihe Biotechnology Co., Ltd., have obtained a medical device registration certificate for the Mycoplasma pneumoniae antigen detection kit (latex method) in China [1] - Multiple products, including influenza A and B antigen detection kits (colloidal gold), Helicobacter pylori antigen detection kits (fecal), Helicobacter pylori antibody detection kits (whole blood/serum/plasma), and COVID-19/flu antigen detection kits (colloidal gold), have received approval for registration in the European Union [1] Group 2: Market Expansion - The registration of these respiratory combined detection kits in both China and the EU enriches and enhances the company's product layout for respiratory specialty testing or combined testing [1] - This development broadens the range of products available for sale, facilitating the detection of seasonal respiratory infections and supporting the overall market expansion of related products domestically and internationally [1]