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Acceptance No. Drug Name Active Ingredient Dosage Form Classification Submission Acceptance Date Manufacturers Manufacturers Review Status Status Date View
CXSS0500083 戊型肝炎病毒IgM抗体酶联免疫诊断试剂盒 Diagnostic reagent IVD New Drug Application 2005-09-01 北京贝尔生物工程有限公司 Beijing Beier Bioengineering Co Ltd Certificate Issued 2007-01-11 view
X0302344 戊型肝炎病毒IgM抗体酶联免疫诊断试剂盒(捕获法) Diagnostic reagent IVD New Drug Application 2003-12-24 北京万泰生物药业有限公司 Beijing Wantai Biological Pharmacy Enterprise Co Ltd Certificate Issued 2004-07-19 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
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
AS20010001 戊型肝炎病毒(IgM)抗体酶联免疫诊断试剂盒 Diagnostic reagent IVD New Drug Application 2001-04-17 新加坡健利检验诊断私人有限公司上海代表处 MP Biomedical Asia Pacific Pte Ltd Shanghai Representative Office Approval Completed-Pending Certificated view