| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
