万孚生物：获四项凝血检测试剂产品注册证

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]