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Acceptance No. Drug Name Active Ingredient Dosage Form Classification Submission Acceptance Date Manufacturers Manufacturers Review Status Status Date View
CSZ20020003 乙型肝炎病毒核酸扩增(PCR)荧光检测试剂盒 Diagnostic reagent IVD(2) New Drug Application 2002-05-30 中山大学达安基因股份有限公司 Daan Gene Co Ltd Certificate Issued 2003-06-11 view
CXL20022782 注射用尖吻蝮蛇凝血酶 Haemocoagulase Agkistrodon Lyophilized Chemical Drugs(1) New Drug Application 2002-10-29 中山大学 Sun Yat-Sen University In Approval view
CXL20022781 尖吻蝮蛇凝血酶 Haemocoagulase Agkistrodon Active ingredient Chemical Drugs(1) New Drug Application 2002-10-29 中山大学 Sun Yat-Sen University Approval Completed-Pending Certificated view
X0400532 萘哌地尔缓释片 naftopidil Tablet, extended release Chemical Drugs(5) New Drug Application 2004-02-06 中山大学中山医学院科技发展有限公司 Guangzhou Zhongshan Medicine Technology Co Ltd Certificate Issued 2005-02-04 view
X0400537 萘哌地尔缓释胶囊 naftopidil Capsules, extended release Chemical Drugs(5) New Drug Application 2004-02-09 中山大学中山医学院科技开发中心 Guangzhou Zhongda Zhongshan Medical Technology Development Co Ltd Certificate Issued 2005-07-29 view
X0405546 甲胎蛋白(AFP)定量诊断试剂盒(时间分辨免疫荧光分析法) Diagnostic reagent IVD New Drug Application 2004-09-30 中山大学达安基因股份有限公司 Daan Gene Co Ltd Certificate Issued 2005-11-03 view
X0407396 自体DC/肾癌融合细胞疫苗 Other Biological Products(3) New Drug Application 2004-12-09 中山大学肿瘤防治中心 Tumor Hospital Under Sun Yat-Sen University Certificate Issued 2008-08-07 view
X0305068 糖视明 滴丸 Pellet Chinese Herbal Medicine(6) New Drug Application 2004-12-22 中山大学中山医学院科技发展有限公司 Guangzhou Zhongshan Medicine Technology Co Ltd Certificate Issued 2005-05-09 view
X0408320 癌胚抗原(CEA)定量检测试剂盒(时间分辨免疫荧光分析法) Diagnostic reagent IVD New Drug Application 2005-01-07 中山大学达安基因股份有限公司 Daan Gene Co Ltd Certificate Issued 2006-05-30 view
CXSS0500003 人巨细胞病毒(HCMV)核酸扩增(PCR)荧光定量检测试剂盒 Diagnostic reagent IVD New Drug Application 2005-02-22 中山大学达安基因股份有限公司 Daan Gene Co Ltd Certificate Issued 2006-07-25 view
CXSB0500034 新型冠状病毒核酸扩增(PCR)荧光检测试剂盒 Diagnostic reagent IVD Supplementary Application 2005-04-27 中山大学达安基因股份有限公司 Daan Gene Co Ltd In Approval 2010-01-27 view
CXSS0500068 人乳头瘤病毒(HPV)6,11型核酸扩增(PCR)荧光定量检测试剂盒 Diagnostic reagent IVD New Drug Application 2005-06-30 中山大学达安基因股份有限公司 Daan Gene Co Ltd Certificate Issued 2007-01-11 view
CXSS0500057 总前列腺特异性抗原(tPSA)定量检测试剂盒(时间分辨免疫荧光分析法) Diagnostic reagent IVD New Drug Application 2005-07-01 中山大学达安基因股份有限公司 Daan Gene Co Ltd Certificate Issued 2006-06-02 view
CXSB0500078 结核分支杆菌核酸扩增(PCR)荧光检测试剂盒 Diagnostic reagent IVD Supplementary Application 2005-09-01 中山大学达安基因股份有限公司 Daan Gene Co Ltd Certificate Issued 2006-02-08 view
CXFS0500061 肺炎支原体(MP)核酸扩增(PCR)荧光定量检测试剂盒 Diagnostic reagent IVD New Drug Application 2005-10-11 中山大学达安基因股份有限公司 Daan Gene Co Ltd Certificate Completed-Pending Issued view
CXSS0500121 乙型肝炎病毒表面抗原(HBsAg)定量测定试剂盒(时间分辨免疫荧光法) Diagnostic reagent IVD New Drug Application 2005-10-28 中山大学达安基因股份有限公司 Daan Gene Co Ltd Certificate Completed-Pending Issued view
CXSS0500122 乙型肝炎病毒表面抗体(HBsAb)定量测定试剂盒(时间分辨免疫荧光法) Diagnostic reagent IVD New Drug Application 2005-10-28 中山大学达安基因股份有限公司 Daan Gene Co Ltd Certificate Completed-Pending Issued view
CXSS0500138 人类免疫缺陷病毒1型(HIV-1)巢式核酸扩增 ( 巢式PCR ) 荧光定量检测试剂盒 Diagnostic reagent IVD New Drug Application 2005-12-29 中山大学达安基因股份有限公司 Daan Gene Co Ltd In Approval 2008-07-08 view
CXSS0600002 乙型肝炎病毒核心抗体(抗-HBc)定量测定试剂盒(时间分辨免疫荧光法) Diagnostic reagent IVD New Drug Application 2006-01-24 中山大学达安基因股份有限公司 Daan Gene Co Ltd In Approval 2008-06-13 view
CXSS0500164 CA125定量测定试剂盒(时间分辨免疫荧光法) Diagnostic reagent IVD New Drug Application 2006-01-24 中山大学达安基因股份有限公司 Daan Gene Co Ltd In Approval 2007-07-13 view