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中山医科大学达安基因诊断中心研制开发的“乙肝病毒ＰＣＲ荧光检测试剂盒”于１９９９年岁末获得了国家药品监督管理局颁发的二类新药证书和试生产批文。这是我国ＰＣＲ诊断试剂盒新的评审办法颁布后第一个正式批准的ＰＣＲ诊断试剂产品。 从１９９６年开始，该中心成功开发出
Zhongshan Medical University, Da-Gene Diagnostics Center developed the “hepatitis B virus PCR fluorescence detection kit” in late 1999 received the State Drug Administration issued two types of new drug certificates and trial production approval. This is the first officially approved PCR diagnostic reagent product after the promulgation of a new assessment method for PCR diagnostic kit in China. Since 1996, the center has been successfully developed