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Acceptance No. Drug Name Active Ingredient Dosage Form Classification Submission Acceptance Date Manufacturers Manufacturers Review Status Status Date 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
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
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
CXSS0800001 血源筛查HBV、HCV、HIV-1病毒核酸检测试剂盒(PCR-荧光探针法) Diagnostic reagent Biological Products New Drug Application 2008-05-19 中山大学达安基因股份有限公司 Daan Gene Co Ltd Certificate Issued 2010-12-07 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
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
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
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
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
X0405546 甲胎蛋白(AFP)定量诊断试剂盒(时间分辨免疫荧光分析法) Diagnostic reagent IVD New Drug Application 2004-09-30 中山大学达安基因股份有限公司 Daan Gene Co Ltd Certificate Issued 2005-11-03 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
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
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
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
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
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
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
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
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