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Acceptance No. Drug Name Active Ingredient Dosage Form Classification Submission Acceptance Date Manufacturers Manufacturers Review Status Status Date View
FS20010013 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 2001-08-10 郑州绿科生物工程有限公司 Approval Completed-Pending Certificated 2001-12-27 view
FS20020001 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 2002-01-31 吉比有生物技术(北京)有限公司 Beijing BGI-GBI Biotech Co Ltd Approval Completed-Pending Certificated 2002-07-19 view
CSb20020155 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 2002-10-29 英科新创(厦门)科技有限公司 InTec Products INC Certificate Issued 2004-01-19 view
CSB20020154 速显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 2003-01-02 英科新创(厦门)科技有限公司 InTec Products INC Pending Approval 2004-09-09 view
CSB20020153 速显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 2003-01-02 英科新创(厦门)科技有限公司 InTec Products INC Certificate Issued 2004-10-15 view
X0302347 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 2003-05-04 上海实业科华生物技术有限公司 Shanghai Siic Kehua Biotech Co Ltd Certificate Issued 2003-09-19 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
X0303287 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 2003-08-29 华美生物工程公司 SINO-AMERICAN BIOTECHNOLOGY Co Ltd Certificate Issued 2004-03-01 view
X0303288 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 2003-08-29 华美生物工程公司 SINO-AMERICAN BIOTECHNOLOGY Co Ltd Certificate Issued 2004-03-01 view
J0401946 乙型肝炎病毒表面抗原诊断试剂盒(酶联免疫法) Diagnostic reagent IVD License Renew 2004-10-22 索林诊断(集团)有限公司 DiaSorin SpA Certificate Issued 2005-04-11 view
Y0415170 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 2004-11-26 北京金伟凯医学生物技术有限公司 Goldenweikai MEDICAL BIOTECHNOLOGY Co Ltd Certificate Issued 2005-06-24 view
Y0402577 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 2004-11-29 北京金豪制药有限公司 Beijing Kinghawk Pharmaceutical Co Ltd Certificate Issued 2005-02-25 view
Y0403706 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 2004-11-29 北京金豪制药有限公司 Beijing Kinghawk Pharmaceutical Co Ltd Certificate Issued 2005-02-25 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
CYSS0500071 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 2005-06-19 北京现代高达生物技术有限责任公司 Beijing Modern Gaoda Biotechnology Co Ltd Certificate Issued 2006-05-29 view
JYSB0500071 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 2005-08-25 生物梅里埃公司 Biomerieux Bv Certificate Completed-Pending Issued 2006-06-08 view
JYSB0500092 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 2005-11-09 生物梅里埃公司 Biomerieux Bv Certificate Completed-Pending Issued 2006-05-31 view
CYSS0600007 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 2006-03-01 威海威高生物科技有限公司 Weihai Weigao BIOTECHNOLOGY Co Ltd Certificate Issued 2007-10-10 view
CYSS0600011 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 2006-03-06 北京贝尔生物工程有限公司 Beijing Beier Bioengineering Co Ltd Certificate Issued 2006-09-06 view
JYSB0600077 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 2006-08-02 生物梅里埃公司 Biomerieux Bv Certificate Issued 2007-08-13 view