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