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Acceptance No. Drug Name Active Ingredient Dosage Form Classification Submission Acceptance Date Manufacturers Manufacturers Review Status Status Date 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
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
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 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 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
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
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 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 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
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