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纤维蛋白原测定试剂盒(凝固法)
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万孚生物:获四项凝血检测试剂产品注册证
Zhong Zheng Wang· 2025-09-24 01:32
Core Viewpoint - Wanfu Biological (300482) has recently received four medical device registration certificates from the Guangdong Provincial Drug Administration, enhancing its product line in the in vitro diagnostic field [1] Product Approval Details - The four approved products include: - Fibrinogen (original) degradation product determination kit (immunoturbidimetric method) - Fibrinogen determination kit (coagulation method) - D-dimer determination kit (immunoturbidimetric method) - Anti-Xa determination kit (color substrate method) [1] - All four products have a registration certificate validity until 2030 and are used for assisting in the diagnosis of primary and secondary fibrinolysis, disseminated intravascular coagulation, and primary fibrinolytic syndrome, as well as monitoring thrombolytic efficacy and heparin activity [1] Market Demand and Competitive Position - Coagulation testing is a crucial component of clinical diagnosis, with increasing demand driven by an aging population and rising incidence of cardiovascular diseases [1] - The approval of these new products will complete the company's coagulation index detection solution, enhancing its core competitiveness in the in vitro diagnostic market [1]
万孚生物(300482.SZ)收到多项医疗器械注册证
智通财经网· 2025-09-23 08:56
智通财经APP讯,万孚生物(300482.SZ)公告,公司近日收到广东省药品监督管理局颁发的医疗器械注册 证,产品名称分别为:纤维蛋白(原)降解产物测定试剂盒(免疫比浊法)、纤维蛋白原测定试剂盒(凝固 法)、D-二聚体测定试剂盒(免疫比浊法)、抗Xa测定试剂盒(发色底物法)。 ...