肿瘤标志物检测试剂

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万孚生物上市九项新品
Zheng Quan Ri Bao Wang· 2025-07-30 00:45
Core Insights - Guangzhou Wondfo Biotech Co., Ltd. has received approval from the National Medical Products Administration and the Guangdong Provincial Medical Products Administration for nine self-developed test kits [1] - The newly approved thrombus five-item test and tumor marker test kits will provide a richer testing menu and more convenient combinations for clinical use [1] Group 1: Product Development - The thrombus five-item test, including D-Dimer, aids in the auxiliary diagnosis of thrombotic diseases, early diagnosis of DIC, monitoring of thrombolytic and anticoagulant drug efficacy, and diagnosis of vascular endothelial system damage [1] - Wondfo Biotech has launched multiple fully automated chemiluminescence immunoassay analyzers with varying throughput, catering to different application scenarios [1] Group 2: Market Position and Future Plans - The company has obtained over 150 medical device product registrations globally, covering nine major areas including cardiac markers, inflammation, thrombosis, thyroid, sex hormones, anemia, bone metabolism, tumors, and infectious disease testing [1] - Wondfo Biotech aims to continue leveraging its high-level, global R&D innovation system, focusing on technological, product, and service innovations to benefit the public [1]
万孚生物:全资子公司9款检测试剂盒获批上市
Zheng Quan Shi Bao Wang· 2025-07-29 12:25
Core Viewpoint - Wanfu Biology's subsidiary, Tianshen Medical, has received approval for nine self-developed test kits from the National Medical Products Administration and Guangdong Provincial Drug Administration, enhancing clinical testing options [1] Group 1: Product Development - The approved test kits include thrombosis five-item tests and tumor marker tests, providing a richer testing menu and more convenient combinations for clinical use [1] - By July 2025, Wanfu Biology's single-use chemiluminescence system is expected to have obtained 16 medical device registration certificates for tumor marker detection, making it the most comprehensive small-scale luminescence system in China [1] Group 2: Market Position - Wanfu Biology's single-use chemiluminescence product line has received over 150 medical device registration certificates globally, covering nine major testing areas including cardiac markers, inflammation, thrombosis, thyroid, sex hormones, anemia, bone metabolism, tumors, and infectious diseases [1]
万孚生物子公司9项产品取得注册证
Bei Jing Shang Bao· 2025-07-29 12:19
Group 1 - The company Wanfu Bio announced that its wholly-owned subsidiary Shenzhen Tianshen Medical Device Co., Ltd. has received 9 medical device registration certificates from the National Medical Products Administration and Guangdong Provincial Medical Products Administration [1] - The registered products include thrombosis detection reagents and tumor marker detection reagents [1]
万孚生物:全资子公司取得产品注册证
Mei Ri Jing Ji Xin Wen· 2025-07-29 08:56
每经AI快讯,万孚生物(300482)7月29日晚间公告,公司全资子公司深圳天深医疗器械有限公司近日收 到国家药品监督管理局及广东省药品监督管理局颁发的医疗器械注册证,包括血栓五项检测试剂和肿瘤 标志物检测试剂等。 (文章来源:每日经济新闻) ...