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结合PCR类检测试剂产品工艺特点、产品技术要求及《体外诊断试剂注册管理办法》等现行法规的要求，分析PCR类检测试剂生产过程中的生产环境、原材料质量要求、工艺用水及产品性能检测等方面的关键控制点，为该类体外诊断试剂在生产质量管理和产品注册方面提供一定的技术参考。“,”Combining with the characteristics of PCR Detection Reagents, product technology requirement and the current regulations requirements such as measures for the administration of IVD registration, the article analysis the critical control points about environmental requirements、raw materials quality、process water and testing methods in manufacture process of PCR detection reagents,so as to to provide certain technical reference for its product quality management in manufacture process and product registration.