主要负责体外诊断试剂检测和医用高分子材料及制品、医用卫生材料及敷料、植入和介入器材及药品包装材料等产品体外生物安全性评价试验。可进行数百种体外诊断试剂产品检测；拥有高级职称人员1人，硕士6人；配有全自动血液分析仪、全自动生化分析仪、荧光定量PCR仪和核酸序列分析仪等大型精密仪器设备。拥有国内一流的分子生物学科研平台，具备体外诊断试剂产品原材料的开发及质量评价能力。

　　The department is mainly engaged in the inspection of in vitro diagnostic reagents and the in vitro biological safety evaluation of medical polymer materials and products, medical materials and dressings, implantable and interventional equipments, and pharmaceutical packaging materials, etc. We can conduct hundreds of product testing of in vitro diagnostic reagents. The department includes one professional staff with senior professional title and six masters. The department was equipped with several advanced instruments, including automatic biochemical analysis system, automatic hematology analyzer with five classifications, real-time PCR system and nucleotide sequencing system, etc. Our department establishes a domestic first-class scientific research platform of molecular biology, which is competent for the exploitation and quality evaluation in raw materials of in vitro diagnostic reagents.

　　部门座右铭        勇于探索，勤于钻研， 在攀登的路上不断挑战自我！