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Acceptance No. Drug Name Active Ingredient Dosage Form Classification Submission Acceptance Date Manufacturers Manufacturers Review Status Status Date View
CSS00085 促黄体激素诊断试剂(胶体金法) Diagnostic reagent IVD(2) New Drug Application 2000-10-18 艾康生物技术(杭州)有限公司 Acon Biotech (Hangzhou) Co Ltd Approval Completed-Pending Certificated 2002-06-14 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
X0402314 甲基安非他命(MET)胶体金法检测试剂 Other IVD New Drug Application 2004-05-08 艾康生物技术(杭州)有限公司 Acon Biotech (Hangzhou) Co Ltd Certificate Issued 2005-08-31 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
X0402853 沙眼衣原体乳胶法检测试剂 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 2005-08-19 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
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
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
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
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
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
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
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
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
CXSS0500062 氯胺酮检测试剂盒(胶体金法) Diagnostic reagent IVD New Drug Application 2005-08-17 艾康生物技术(杭州)有限公司 Acon Biotech (Hangzhou) Co Ltd Certificate Issued 2007-01-11 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
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
CYSS0500083 梅毒螺旋体抗体(Anti-TP)诊断试剂盒(酶联免疫法) Diagnostic reagent IVD Generic Drug 2005-10-13 艾康生物技术(杭州)有限公司 Acon Biotech (Hangzhou) Co Ltd Certificate Issued 2006-05-29 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
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