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Acceptance No. Drug Name Active Ingredient Dosage Form Classification Submission Acceptance Date Manufacturers Manufacturers Review Status Status Date View
CDS01014 尿酸试剂盒(酶比色法) Diagnostic reagent IVD New Drug Application 2002-01-15 上海荣盛生物技术有限公司 Shanghai Rongsheng Biological Pharmaceutical Co Ltd Pending Approval 2002-09-16 view
CDS01011 丙氨酸氨基转移酶试剂盒(连续监测法) Diagnostic reagent IVD New Drug Application 2002-01-15 上海荣盛生物技术有限公司 Shanghai Rongsheng Biological Pharmaceutical Co Ltd Pending Approval 2002-09-16 view
CDS01012 门冬氨酸氨基转移酶试剂盒(连续监测法) Diagnostic reagent IVD New Drug Application 2002-01-15 上海荣盛生物技术有限公司 Shanghai Rongsheng Biological Pharmaceutical Co Ltd Pending Approval 2002-09-16 view
CDS01013 肌酸激酶试剂盒(N-乙酰半胱氨酸法) Diagnostic reagent IVD New Drug Application 2002-01-15 上海荣盛生物技术有限公司 Shanghai Rongsheng Biological Pharmaceutical Co Ltd Pending Approval 2002-09-16 view
CDS01016 总胆红素试剂盒(重氮法) Diagnostic reagent IVD New Drug Application 2002-01-15 上海荣盛生物技术有限公司 Shanghai Rongsheng Biological Pharmaceutical Co Ltd Pending Approval 2002-09-16 view
CDS01015 磷试剂盒(紫外法) Diagnostic reagent IVD New Drug Application 2002-01-15 上海荣盛生物技术有限公司 Shanghai Rongsheng Biological Pharmaceutical Co Ltd Pending Approval 2002-09-16 view
CDS20020003 肌酐测定试验盒(苦味酸法) Diagnostic reagent IVD New Drug Application 2002-05-20 上海荣盛生物技术有限公司 Shanghai Rongsheng Biological Pharmaceutical Co Ltd Pending Approval 2003-09-03 view
CDS20020002 铁测定试剂盒(亚铁嗪比色法) Diagnostic reagent IVD New Drug Application 2002-05-20 上海荣盛生物技术有限公司 Shanghai Rongsheng Biological Pharmaceutical Co Ltd Pending Approval 2002-10-09 view
CDS20020005 低密度脂蛋白胆固醇测定试验盒(直接法) Diagnostic reagent IVD New Drug Application 2002-05-20 上海荣盛生物技术有限公司 Shanghai Rongsheng Biological Pharmaceutical Co Ltd Approval Completed-Pending Certificated view
CDS20020004 高密度脂蛋白胆固醇测定试验盒(直接法) Diagnostic reagent IVD New Drug Application 2002-05-20 上海荣盛生物技术有限公司 Shanghai Rongsheng Biological Pharmaceutical Co Ltd Approval Completed-Pending Certificated view
X0302488 乙型肝炎病毒核心抗体诊断试剂盒(酶联免疫法) Diagnostic reagent IVD Supplementary Application 2003-05-28 上海荣盛生物技术有限公司 Shanghai Rongsheng Biological Pharmaceutical Co Ltd Certificate Issued 2003-11-07 view
X0302492 乙型肝炎病毒e抗体诊断试剂盒(酶联免疫法) Diagnostic reagent IVD Supplementary Application 2003-05-28 上海荣盛生物技术有限公司 Shanghai Rongsheng Biological Pharmaceutical Co Ltd Certificate Issued 2003-11-18 view
X0302491 乙型肝炎病毒e抗原诊断试剂盒(酶联免疫法) Diagnostic reagent IVD Supplementary Application 2003-05-28 上海荣盛生物技术有限公司 Shanghai Rongsheng Biological Pharmaceutical Co Ltd Certificate Issued 2003-11-18 view
X0302489 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 2003-05-28 上海荣盛生物技术有限公司 Shanghai Rongsheng Biological Pharmaceutical Co Ltd Certificate Issued 2003-11-07 view
X0302497 乙型肝炎病毒表面抗体诊断试剂盒(酶联免疫法) Diagnostic reagent IVD Supplementary Application 2003-06-05 上海荣盛生物技术有限公司 Shanghai Rongsheng Biological Pharmaceutical Co Ltd Certificate Issued 2003-10-17 view
X0404699 流行性感冒裂解疫苗 Influenza Vaccine(Split Virion),Inactivated Injection Biological Products(10) New Drug Application 2004-08-23 上海荣盛生物技术有限公司 Shanghai Rongsheng Biological Pharmaceutical Co Ltd Certificate Issued 2005-08-10 view
Y0304540 甲型肝炎病毒IgM抗体诊断试剂盒(酶联免疫法) Diagnostic reagent IVD Generic Drug 2004-10-27 上海荣盛生物技术有限公司 Shanghai Rongsheng Biological Pharmaceutical Co Ltd Certificate Issued 2005-03-03 view
X0400563 乙型肝炎病毒核心抗体IgM诊断试剂盒(酶联免疫法) Diagnostic reagent IVD New Drug Application 2004-12-03 上海荣盛生物技术有限公司 Shanghai Rongsheng Biological Pharmaceutical Co Ltd Certificate Issued 2005-06-29 view
CXSL0500021 Vero细胞乙型脑炎灭活疫苗 Japanese Encephalitis Vaccine(Vero Cell),Inactivated Injection Biological Products(4) New Drug Application 2005-03-24 上海荣盛生物技术有限公司 Shanghai Rongsheng Biological Pharmaceutical Co Ltd Certificate Issued 2006-02-08 view
CXSL0500019 冻干水痘减毒活疫苗 Lyophilized Biological Products(9) New Drug Application 2005-03-24 上海荣盛生物技术有限公司 Shanghai Rongsheng Biological Pharmaceutical Co Ltd In Review 2005-03-22 view