Core Points - Zhejiang Oriental Gene Biological Products Co., Ltd. and its subsidiaries have recently obtained several medical device registration certificates, enhancing their product offerings in the respiratory infection detection market [1][2] - The approval of the influenza virus antigen detection kits will help the company address seasonal respiratory infections, while the certification of various antibody detection kits will expand the application of their flow cytometry technology platform [1] - The FDA approval of the fentanyl fluorescence immunoassay test kit marks the company's first FDA-approved fluorescence immunoassay product, which is expected to improve drug abuse detection accuracy in the U.S. market [2] Summary by Categories Domestic Medical Device Registration - The company has received registration certificates for influenza virus antigen detection kits, which will diversify its product range in the domestic respiratory infection detection market [1] International Medical Device Registration - The FDA approval of the fentanyl fluorescence immunoassay test kit is a significant milestone for the company, enhancing its presence in the U.S. market [2] Impact on the Company - The new certifications are expected to broaden the company's product offerings and support overall market expansion in China, particularly in the field of respiratory infections and drug abuse detection [1][2]

格隆汇8月18日丨东方生物(688298.SH)公布，公司及全资子公司HealgenScientificLLC（简称"美国衡健"）、上海万子健生物技 术有限公司（简称"上海万子健生物"）近日取得了以下几款医疗器械注册证书。公司甲型/乙型流感病毒抗原检测试剂的取 证，进一步丰富了公司在国内呼吸道联检领域的可销售产品种类，有利于应对常规季节性呼吸道感染的检测；抗髓过氧化物 酶抗体、抗蛋白酶3抗体、抗肾小球基底膜抗体检测试剂的获证，丰富了流式荧光（原液态生物芯片）技术平台的配套检测试 剂品种，扩展了流式荧光发光法的应用领域，有利于国内市场的整体拓展。美国衡健的芬太尼荧光免疫层析检测试剂（配套 OG-180荧光免疫分析仪）是公司第一款获得美国FDA审批的荧光免疫检测产品，该产品适用于专业机构使用，灵敏度和特异 性高，有利于提高药物滥用检测的精准度，有利于美国市场的拓展。 | 产品名称 | 适用国家及证 书编号 | 证书类型 | 预期用途 | 有效期 | 持证 公司 | | --- | --- | --- | --- | --- | --- | | 甲型/乙型流感病毒抗原 | 国械注准 | | 本产品用于体外定性检测人 ...