14种高危型HPV核酸检测及16/18分型试剂
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浙江东方基因生物制品股份有限公司 关于自愿披露获得医疗器械注册证的公告
Zhong Guo Zheng Quan Bao - Zhong Zheng Wang· 2025-09-23 08:26
Core Viewpoint - Zhejiang Oriental Gene Biological Products Co., Ltd. has obtained registration certificates for several medical device products, enhancing its product offerings in HPV virus detection and respiratory virus testing [1][2]. Group 1: Medical Device Registration - The company’s subsidiary, Hangzhou Danwei Biotechnology Co., Ltd., has received registration certificates for 14 types of high-risk HPV nucleic acid detection and 16/18 typing reagents in China, expanding the company's product range for HPV virus detection [1]. - Additionally, the company has obtained registration for COVID-19 and influenza A/B virus nucleic acid co-detection reagents, further improving its portfolio in respiratory combined detection products [1]. Group 2: Impact on the Company - The new product registrations are expected to broaden the company's sales offerings in molecular diagnostic technology, facilitating overall market expansion in China [1].