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Acceptance No. Drug Name Active Ingredient Dosage Form Classification Submission Acceptance Date Manufacturers Manufacturers Review Status Status Date View
CXFS0900007 人类免疫缺陷病毒抗原抗体检测试剂盒(酶联免疫法) Diagnostic reagent IVD New Drug Application 2010-09-15 北京现代高达生物技术有限责任公司 Beijing Modern Gaoda Biotechnology Co Ltd Certificate Issued 2011-08-03 view
CYFB1000006 人类免疫缺陷病毒HIV(1+2)抗体诊断试剂盒(酶联免疫法) Diagnostic reagent IVD Supplementary Application 2010-06-13 北京现代高达生物技术有限责任公司 Beijing Modern Gaoda Biotechnology Co Ltd Certificate Issued 2010-11-12 view
CYFB1000008 梅毒螺旋体抗体诊断试剂盒(酶联免疫法) Diagnostic reagent IVD Supplementary Application 2010-06-13 北京现代高达生物技术有限责任公司 Beijing Modern Gaoda Biotechnology Co Ltd Certificate Issued 2010-11-12 view
CYFB1000007 梅毒螺旋体抗体诊断试剂盒(酶联免疫法) Diagnostic reagent IVD Supplementary Application 2010-06-13 北京现代高达生物技术有限责任公司 Beijing Modern Gaoda Biotechnology Co Ltd Certificate Issued 2010-11-12 view
CYFB1000005 丙肝病毒抗体酶免测定试剂盒 Diagnostic reagent IVD Supplementary Application 2010-06-13 北京现代高达生物技术有限责任公司 Beijing Modern Gaoda Biotechnology Co Ltd Certificate Issued 2010-11-12 view
CYFB1000009 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 2010-05-27 北京现代高达生物技术有限责任公司 Beijing Modern Gaoda Biotechnology Co Ltd Certificate Issued 2010-11-12 view
CYSS0600092 癌胚抗原诊断试剂盒(酶联免疫法) Diagnostic reagent IVD Generic Drug 2007-03-02 北京现代高达生物技术有限责任公司 Beijing Modern Gaoda Biotechnology Co Ltd In Approval 2008-08-28 view
CYSS0600093 前列腺特异抗原诊断试剂盒(酶联免疫法) Diagnostic reagent IVD Generic Drug 2007-03-02 北京现代高达生物技术有限责任公司 Beijing Modern Gaoda Biotechnology Co Ltd In Approval 2008-08-28 view
CYSS0600080 乙型肝炎病毒e抗原诊断试剂盒(酶联免疫法) Diagnostic reagent IVD Generic Drug 2006-12-07 北京现代高达生物技术有限责任公司 Beijing Modern Gaoda Biotechnology Co Ltd In Approval 2008-07-24 view
CXSB0600021 快速结核抗体IgG诊断试剂盒(胶体金法) Diagnostic reagent IVD Supplementary Application 2006-05-12 北京现代高达生物技术有限责任公司 Beijing Modern Gaoda Biotechnology Co Ltd Certificate Completed-Pending Issued 2007-04-19 view
CYSS0500133 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 2006-02-24 北京现代高达生物技术有限责任公司 Beijing Modern Gaoda Biotechnology Co Ltd Certificate Completed-Pending Issued view
CYSS0600005 甲胎蛋白诊断试剂盒(酶联免疫法) Diagnostic reagent IVD Generic Drug 2006-02-22 北京现代高达生物技术有限责任公司 Beijing Modern Gaoda Biotechnology Co Ltd In Review 2008-03-20 view
CYSS0500132 乙型肝炎病毒e抗原诊断试剂盒(酶联免疫法) Diagnostic reagent IVD Generic Drug 2006-02-22 北京现代高达生物技术有限责任公司 Beijing Modern Gaoda Biotechnology Co Ltd Certificate Issued 2006-07-31 view
CYSS0500085 戊型肝炎病毒IgM抗体酶联免疫诊断试剂盒(酶联免疫捕获法) Diagnostic reagent IVD Generic Drug 2005-11-10 北京现代高达生物技术有限责任公司 Beijing Modern Gaoda Biotechnology Co Ltd Certificate Issued 2007-01-11 view
CXSS0500117 单纯疱疹病毒Ⅱ型IgM抗体诊断试剂盒(酶联免疫捕获法) Diagnostic reagent IVD New Drug Application 2005-10-25 北京现代高达生物技术有限责任公司 Beijing Modern Gaoda Biotechnology Co Ltd Certificate Completed-Pending Issued view
CXSS0500101 弓形虫IgM抗体诊断试剂盒(酶联免疫捕获法) Diagnostic reagent IVD New Drug Application 2005-09-01 北京现代高达生物技术有限责任公司 Beijing Modern Gaoda Biotechnology Co Ltd Certificate Issued 2007-01-11 view
CXSS0500082 戊型肝炎病毒IgM抗体酶联免疫诊断试剂盒(酶联免疫捕获法) Diagnostic reagent IVD New Drug Application 2005-09-01 北京现代高达生物技术有限责任公司 Beijing Modern Gaoda Biotechnology Co Ltd Certificate Issued 2010-03-18 view
CXSS0500060 巨细胞病毒IgM抗体酶联检测试剂盒(捕获法) Diagnostic reagent IVD New Drug Application 2005-06-24 北京现代高达生物技术有限责任公司 Beijing Modern Gaoda Biotechnology Co Ltd Certificate Issued 2006-12-07 view
CYSS0500075 乙型肝炎病毒E抗体诊断试剂盒(酶联免疫法) Diagnostic reagent IVD Retrial 2005-06-23 北京现代高达生物技术有限责任公司 Beijing Modern Gaoda Biotechnology Co Ltd Certificate Issued 2006-08-29 view
CYSS0500073 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 2005-06-19 北京现代高达生物技术有限责任公司 Beijing Modern Gaoda Biotechnology Co Ltd Certificate Issued 2006-06-08 view