万孚生物四项产品取得产品注册证

Core Viewpoint - Wanfu Bio has received medical device registration certificates from the Guangdong Provincial Drug Administration for several diagnostic kits, indicating a significant advancement in its product offerings in the medical diagnostics sector [1] Product Summary - The company announced the approval of the following diagnostic kits: - Fibrinogen (original) degradation product determination kit (immunoturbidimetric method) for quantitative detection of fibrinogen degradation products (FDP) in human plasma, aiding in the diagnosis of primary and secondary fibrinolysis [1] - Fibrinogen determination kit (coagulation method) for quantitative measurement of fibrinogen levels in human plasma, primarily used for diagnosing disseminated intravascular coagulation and monitoring thrombolytic therapy [1] - D-dimer determination kit (immunoturbidimetric method) for quantitative detection of D-dimer levels in human plasma, mainly used for diagnosing disseminated intravascular coagulation and monitoring thrombolytic treatment [1] - Anti-Xa determination kit (color substrate method) for quantitative measurement of the activity of unfractionated heparin (UFH) and low molecular weight heparin (LMWH) in human citrate anticoagulated plasma [1]