| 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 |
| 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 |
| 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 |
| 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 |
| 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;Guangzhou Darui Biotechnology Co Ltd | In Approval | 2008-07-29 | 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 |
| 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;Guangzhou Darui Biotechnology Co Ltd | In Approval | 2008-06-13 | 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;Guangzhou Darui Biotechnology Co Ltd | Approval Completed-Pending Certificated | | 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 |
| CXSS0500166 | EB病毒（EBV）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 | In Approval | 2008-07-29 | 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;Guangzhou Darui Biotechnology Co Ltd | In Approval | 2008-07-29 | 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 |
| 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;Guangzhou Darui Biotechnology Co Ltd | In Approval | 2008-06-13 | view |
| CXSS0500169 | 淋球菌（NGH）核酸扩增（PCR）荧光定量检测试剂盒 | | 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 |
| 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 |
| 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 |
| 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 |
| 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;Guangzhou Darui Biotechnology Co Ltd | Certificate Issued | 2006-06-02 | view |
