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Acceptance No. Drug Name Active Ingredient Dosage Form Classification Submission Acceptance Date Manufacturers Manufacturers Review Status Status Date View
CXSS0600049 丙型肝炎病毒RNA定量荧光PCR检测试剂盒 Diagnostic reagent IVD New Drug Application 2006-06-02 艾康生物技术(杭州)有限公司 Acon Biotech (Hangzhou) Co Ltd In Approval 2008-08-07 view
CXSS0500126 丙型肝炎病毒抗体检测试剂(胶体金法) Diagnostic reagent IVD New Drug Application 2005-12-12 艾康生物技术(杭州)有限公司 Acon Biotech (Hangzhou) Co Ltd Certificate Issued 2009-04-08 view
CYFB1100110 丙型肝炎病毒抗体诊断试剂盒(酶联免疫法) Diagnostic reagent IVD Supplementary Application 2011-08-29 艾康生物技术(杭州)有限公司 Acon Biotech (Hangzhou) Co Ltd Certificate Issued 2012-01-16 view
CYSS0500097 丙型肝炎病毒抗体诊断试剂盒(酶联免疫法) Diagnostic reagent IVD Generic Drug 2005-12-12 艾康生物技术(杭州)有限公司 Acon Biotech (Hangzhou) Co Ltd Certificate Issued 2006-08-29 view
CYSS0500039 乙型肝炎病毒e抗体诊断试剂盒(酶联免疫法) Diagnostic reagent IVD Generic Drug 2005-05-17 艾康生物技术(杭州)有限公司 Acon Biotech (Hangzhou) Co Ltd Certificate Issued 2005-12-09 view
CYSS0500040 乙型肝炎病毒e抗原诊断试剂盒(酶联免疫法) Diagnostic reagent IVD Generic Drug 2005-05-17 艾康生物技术(杭州)有限公司 Acon Biotech (Hangzhou) Co Ltd Certificate Issued 2005-12-09 view
CXSS0500018 乙型肝炎病毒YMDD变异及DNA定量荧光PCR双检试剂盒 Diagnostic reagent IVD New Drug Application 2005-03-02 艾康生物技术(杭州)有限公司 Acon Biotech (Hangzhou) Co Ltd Certificate Issued 2006-04-19 view
CYSS0600053 乙型肝炎病毒核心抗体(HBcAb)诊断试剂盒(酶联免疫法) Diagnostic reagent IVD Generic Drug 2006-06-02 艾康生物技术(杭州)有限公司 Acon Biotech (Hangzhou) Co Ltd Certificate Completed-Pending Issued view
CYSS0500038 乙型肝炎病毒核心抗体诊断试剂盒(酶联免疫法) Diagnostic reagent IVD Generic Drug 2005-05-17 艾康生物技术(杭州)有限公司 Acon Biotech (Hangzhou) Co Ltd Certificate Issued 2005-10-21 view
CYSS0500041 乙型肝炎病毒表面抗体诊断试剂盒(酶联免疫法) Diagnostic reagent IVD Generic Drug 2005-05-17 艾康生物技术(杭州)有限公司 Acon Biotech (Hangzhou) Co Ltd Certificate Issued 2005-12-07 view
CYSB1000187 乙型肝炎病毒表面抗原诊断试剂盒(酶联免疫法) Diagnostic reagent IVD Supplementary Application 2010-09-15 艾康生物技术(杭州)有限公司 Acon Biotech (Hangzhou) Co Ltd Certificate Issued 2010-12-01 view
CYSS0500037 乙型肝炎病毒表面抗原诊断试剂盒(酶联免疫法) Diagnostic reagent IVD Generic Drug 2005-05-17 艾康生物技术(杭州)有限公司 Acon Biotech (Hangzhou) Co Ltd Certificate Issued 2005-12-07 view
X0402674 乙肝两对半(HBV)检测试剂(乳胶法) Diagnostic reagent IVD New Drug Application 2004-12-09 艾康生物技术(杭州)有限公司 Acon Biotech (Hangzhou) Co Ltd Certificate Issued 2005-05-09 view
X0404453 乙肝病毒表面抗原胶体金法检测试剂 Diagnostic reagent IVD Supplementary Application 2004-08-12 艾康生物技术(杭州)有限公司 Acon Biotech (Hangzhou) Co Ltd Certificate Issued 2004-12-15 view
CXSS0500007 乙肝表面抗体检测试剂(乳胶法) Diagnostic reagent IVD New Drug Application 2005-02-22 艾康生物技术(杭州)有限公司 Acon Biotech (Hangzhou) Co Ltd Certificate Issued 2006-02-10 view
CYSB1000188 人类免疫缺陷病毒抗体(1型/2型/O亚型)诊断试剂盒(酶联免疫法) Diagnostic reagent IVD Supplementary Application 2010-09-15 艾康生物技术(杭州)有限公司 Acon Biotech (Hangzhou) Co Ltd Certificate Issued 2011-01-24 view
CXSS0500091 人类免疫缺陷病毒抗体HIV(1/2/O)诊断试剂盒(酶联免疫法) Diagnostic reagent IVD New Drug Application 2005-08-01 艾康生物技术(杭州)有限公司 Acon Biotech (Hangzhou) Co Ltd Certificate Issued 2006-06-08 view
CXSS0500104 人类免疫缺陷病毒(HIV)1/2/O型抗体诊断试剂(乳胶层析法) Diagnostic reagent IVD New Drug Application 2005-10-13 艾康生物技术(杭州)有限公司 Acon Biotech (Hangzhou) Co Ltd Certificate Issued 2006-12-05 view
CXSB0500105 人类免疫缺陷病毒(HIV)1/2型抗体诊断试剂(乳胶层析法) Diagnostic reagent IVD Supplementary Application 2005-10-11 艾康生物技术(杭州)有限公司 Acon Biotech (Hangzhou) Co Ltd Certificate Issued 2008-04-28 view
X0302475 便隐血胶体金法检测试剂 Diagnostic reagent IVD New Drug Application 2004-01-15 艾康生物技术(杭州)有限公司 Acon Biotech (Hangzhou) Co Ltd Certificate Issued 2004-07-12 view