| 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 |
| 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 |
| 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 |
| CXSS0500170 | 人乳头瘤病毒（HPV）反向点杂交（RDB）基因分型检测试剂盒 | | Diagnostic reagent | IVD | New Drug Application | 2006-04-02 | 中山大学达安基因股份有限公司 | Daan Gene Co Ltd | In Approval | 2008-07-29 | 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| CXFB1700002 | 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 | 2017-11-28 | 中山大学达安基因股份有限公司 | Daan Gene Co Ltd | Certificate Issued | 2018-02-23 | 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
