| 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 |
| 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 |
| CXSS0500173 | 单纯疱疹病毒Ⅱ型（HSVⅡ）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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| CXSS0500165 | CA19-9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 | Certificate Completed-Pending Issued | | view |
| CXSS0500161 | α－地中海贫血基因诊断试剂盒（gap-PCR法） | | 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 |
| 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 |
| CXSS0500154 | 解脲脲原体（UU）核酸扩增（PCR）荧光定量检测试剂盒 | | 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 | Certificate Completed-Pending Issued | | view |
| CXSS0600001 | 乙型肝炎病毒e抗体（抗-HBe）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 | Approval Completed-Pending Certificated | | 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 |
| 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 |
| 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 |
| 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 |
| 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 |
