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Acceptance No. Drug Name Active Ingredient Dosage Form Classification Submission Acceptance Date Manufacturers Manufacturers Review Status Status Date View
CXSS0500133 乙型肝炎病毒核心IgM抗体诊断试剂盒(酶联免疫法) Diagnostic reagent IVD New Drug Application 2005-12-29 潍坊三维生物工程集团有限公司 Weifang Sanwei Bioengineering Group Co Ltd Certificate Completed-Pending Issued view
CYFB1000070 梅毒螺旋体抗体诊断试剂盒(酶联免疫法) Diagnostic reagent IVD Supplementary Application 2010-12-08 潍坊三维生物工程集团有限公司 Weifang Sanwei Bioengineering Group Co Ltd Certificate Issued 2011-03-25 view
CYFB1000071 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 2010-12-08 潍坊三维生物工程集团有限公司 Weifang Sanwei Bioengineering Group Co Ltd Certificate Issued 2011-03-25 view
CYFB1000072 丙型肝炎病毒抗体诊断试剂盒(酶联免疫法) Diagnostic reagent IVD Supplementary Application 2010-12-08 潍坊三维生物工程集团有限公司 Weifang Sanwei Bioengineering Group Co Ltd Certificate Issued 2011-03-25 view
CYFB1000073 人类免疫缺陷病毒抗体诊断试剂盒(酶联免疫法) Diagnostic reagent IVD Supplementary Application 2010-12-08 潍坊三维生物工程集团有限公司 Weifang Sanwei Bioengineering Group Co Ltd Certificate Issued 2011-04-27 view
CYSS0500006 人类免疫缺陷病毒HIV(1+2)型抗体诊断试剂盒(酶联免疫法) Diagnostic reagent IVD Generic Drug 2005-02-22 潍坊三维生物工程集团有限公司 Weifang Sanwei Bioengineering Group Co Ltd Certificate Issued 2006-04-04 view
CYSS0500024 甲胎蛋白(定量)诊断试剂盒(酶联免疫法) Diagnostic reagent IVD Generic Drug 2005-03-22 潍坊三维生物工程集团有限公司 Weifang Sanwei Bioengineering Group Co Ltd Certificate Issued 2006-04-14 view
CYSS0500056 甲型肝炎病毒IgM抗体诊断试剂盒(酶联免疫法) Diagnostic reagent IVD Generic Drug 2005-08-24 潍坊三维生物工程集团有限公司 Weifang Sanwei Bioengineering Group Co Ltd Certificate Issued 2006-06-28 view
CYSS0500057 癌胚抗原诊断试剂盒(酶联免疫法) Diagnostic reagent IVD Generic Drug 2005-08-24 潍坊三维生物工程集团有限公司 Weifang Sanwei Bioengineering Group Co Ltd Certificate Issued 2006-08-29 view
CYSS0500077 丙型肝炎病毒抗体诊断试剂盒(酶联免疫法) Diagnostic reagent IVD Generic Drug 2005-08-24 潍坊三维生物工程集团有限公司 Weifang Sanwei Bioengineering Group Co Ltd Certificate Issued 2006-06-28 view
CYSS0500108 甲型肝炎病毒IgG抗体诊断试剂盒(酶联免疫法) Diagnostic reagent IVD Generic Drug 2005-12-07 潍坊三维生物工程集团有限公司 Weifang Sanwei Bioengineering Group Co Ltd Certificate Completed-Pending Issued view
CYSS0600057 人血清胰岛素放射免疫分析试剂盒 Diagnostic reagent IVD Generic Drug 2006-08-20 潍坊三维生物工程集团有限公司 Weifang Sanwei Bioengineering Group Co Ltd Certificate Issued 2008-10-17 view
CYSS0600058 人血清游离甲状腺素放射免疫分析试剂盒 Diagnostic reagent IVD Generic Drug 2006-08-20 潍坊三维生物工程集团有限公司 Weifang Sanwei Bioengineering Group Co Ltd Certificate Issued 2008-10-17 view
CYSS0600059 人血清促甲状腺激素免疫放射分析试剂盒 Diagnostic reagent IVD Generic Drug 2006-08-20 潍坊三维生物工程集团有限公司 Weifang Sanwei Bioengineering Group Co Ltd Certificate Issued 2008-10-17 view
CYSS0600060 人血清C-肽放射免疫分析试剂盒 Diagnostic reagent IVD Generic Drug 2006-08-20 潍坊三维生物工程集团有限公司 Weifang Sanwei Bioengineering Group Co Ltd Certificate Issued 2008-10-17 view
CYSS0600061 人血清游离三碘甲状腺原氨酸放射免疫分析试剂盒 Diagnostic reagent IVD Generic Drug 2006-08-20 潍坊三维生物工程集团有限公司 Weifang Sanwei Bioengineering Group Co Ltd Certificate Issued 2008-10-17 view
CYSS0600062 甲状腺球蛋白抗体、微粒体抗体放射免疫分析试剂盒 Diagnostic reagent IVD Generic Drug 2006-08-20 潍坊三维生物工程集团有限公司 Weifang Sanwei Bioengineering Group Co Ltd Certificate Issued 2008-10-17 view
CYSS0800001 碘[125I]催乳素放射免疫分析药盒 Diagnostic reagent IVD Generic Drug 2008-07-09 潍坊三维生物工程集团有限公司 Weifang Sanwei Bioengineering Group Co Ltd Certificate Issued 2015-02-05 view
CYSS0800002 碘[125I]睾酮放射免疫分析药盒 Diagnostic reagent IVD Generic Drug 2008-07-09 潍坊三维生物工程集团有限公司 Weifang Sanwei Bioengineering Group Co Ltd Certificate Issued 2015-02-05 view
CYSS0800003 碘[125I]孕酮放射免疫分析药盒 Diagnostic reagent IVD Generic Drug 2008-07-09 潍坊三维生物工程集团有限公司 Weifang Sanwei Bioengineering Group Co Ltd Certificate Issued 2015-02-05 view