| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| CYSB2000339 | 乙型肝炎病毒丙型肝炎病毒人类免疫缺陷病毒（1型）核酸检测试剂盒（PCR-荧光法） | | Diagnostic reagent | IVD | Supplementary Application | 2020-12-14 | 中山大学达安基因股份有限公司 | Daan Gene Co Ltd | In Review | 2020-12-11 | view |
| CYFB1600009 | 乙型肝炎病毒丙型肝炎病毒人类免疫缺陷病毒(1型)核酸检测试剂盒(PCR-荧光法) | | Diagnostic reagent | IVD | Supplementary Application | 2016-02-29 | 中山大学达安基因股份有限公司 | Daan Gene Co Ltd | Certificate Issued | 2016-08-01 | view |
| CXZL1400090 | 咽炎方合剂 | | Oral solution | Chinese Herbal Medicine(6.1) | New Drug Application | 2015-06-11 | 中山大学附属第一医院 | First Affiliated Hospital Of Sun Yat-Sen University | Certificate Issued | 2016-09-11 | view |
| CXZL1200071 | 芩夷感冒颗粒 | | Granule | Chinese Herbal Medicine(6.1) | New Drug Application | 2013-02-06 | 中山大学 | Sun Yat-Sen University | Certificate Issued | 2014-01-16 | view |
| CXZL0600123 | 糖脉交泰胶囊 | | Capsule | Chinese Herbal Medicine(6) | New Drug Application | 2006-06-02 | 中山大学 | Sun Yat-Sen University | Certificate Issued | 2008-02-28 | view |
| CXSS0800001 | 血源筛查HBV、HCV、HIV-1病毒核酸检测试剂盒（PCR-荧光探针法） | | Diagnostic reagent | Biological Products | New Drug Application | 2008-05-19 | 中山大学达安基因股份有限公司 | Daan Gene Co Ltd | Certificate Issued | 2010-12-07 | view |
| CXSS0600134 | β地中海贫血反向点杂交（RDB）基因分型检测试剂盒 | | Diagnostic reagent | IVD | New Drug Application | 2007-02-07 | 中山大学达安基因股份有限公司 | Daan Gene Co Ltd | Approval Completed-Pending Certificated | | view |
| CXSS0600102 | 神经元特异性烯醇化酶定量测定试剂盒（时间分辨免疫荧光法） | | Diagnostic reagent | IVD | New Drug Application | 2006-11-01 | 中山大学达安基因股份有限公司 | Daan Gene Co Ltd | In Approval | 2008-07-29 | view |
| CXSS0600101 | 细胞角蛋白19片段定量测定试剂盒（时间分辨免疫荧光法） | | Diagnostic reagent | IVD | New Drug Application | 2006-11-01 | 中山大学达安基因股份有限公司 | Daan Gene Co Ltd | In Approval | 2008-07-29 | view |
| CXSS0600044 | 游离前列腺特异性抗原定量测定试剂盒（时间分辨免疫荧光法） | | Diagnostic reagent | IVD | New Drug Application | 2006-04-19 | 中山大学达安基因股份有限公司 | Daan Gene Co Ltd | Approval Completed-Pending Certificated | | view |
| CXSS0600043 | CA15-3定量测定试剂盒（时间分辨免疫荧光法） | | Diagnostic reagent | IVD | New Drug Application | 2006-04-19 | 中山大学达安基因股份有限公司 | Daan Gene Co Ltd | Approval Completed-Pending Certificated | | view |
| CXSS0600008 | 解脲脲原体（UU）基因分型反向点杂交（RDB）检测试剂盒 | | Diagnostic reagent | IVD | New Drug Application | 2006-05-16 | 中山大学达安基因股份有限公司 | Daan Gene Co Ltd | Approval Completed-Pending Certificated | | view |
| CXSS0600006 | 高危型人乳头瘤病毒（HR-HPV）核酸扩增（PCR）荧光定量检测试剂盒 | | Diagnostic reagent | IVD | New Drug Application | 2006-03-02 | 中山大学达安基因股份有限公司 | Daan Gene Co Ltd | Certificate Completed-Pending Issued | | view |
| CXSS0600003 | 乙型肝炎病毒e抗原（HBeAg）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 |
