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Acceptance No. Drug Name Active Ingredient Dosage Form Classification Submission Acceptance Date Manufacturers Manufacturers Review Status Status Date View
X0304633 EB病毒VCA/IgA抗体酶联免疫检测试剂盒 Diagnostic reagent IVD New Drug Application 2003-09-06 北京贝尔生物工程有限公司 Beijing Beier Bioengineering Co Ltd Certificate Issued 2004-11-16 view
CXSS0600034 乙型肝炎病毒前S2抗原诊断试剂盒(酶联免疫法) Diagnostic reagent IVD New Drug Application 2006-03-07 北京贝尔生物工程有限公司 Beijing Beier Bioengineering Co Ltd Certificate Completed-Pending Issued view
CYSS0600099 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 2007-01-10 北京贝尔生物工程有限公司 Beijing Beier Bioengineering Co Ltd In Approval 2008-12-30 view
CSb01034 抗幽门螺杆菌抗体酶联免疫法诊断试剂盒 Diagnostic reagent IVD Supplementary Application 2001-07-30 北京贝尔生物工程有限公司 Beijing Beier Bioengineering Co Ltd Certificate Issued 2003-05-09 view
CXSS0600110 单纯疱疹病毒Ⅱ型IgM抗体诊断试剂盒(酶联免疫法) Diagnostic reagent IVD New Drug Application 2006-12-07 北京贝尔生物工程有限公司 Beijing Beier Bioengineering Co Ltd In Approval 2008-07-29 view
CXSS0700016 人狂犬病病毒抗体(IgG)诊断试剂盒(酶联免疫法) Diagnostic reagent IVD New Drug Application 2007-03-29 北京贝尔生物工程有限公司 Beijing Beier Bioengineering Co Ltd Certificate Issued 2008-12-22 view
CXSS0600033 风疹病毒IgM抗体诊断试剂盒(酶联免疫法) Diagnostic reagent IVD New Drug Application 2006-03-07 北京贝尔生物工程有限公司 Beijing Beier Bioengineering Co Ltd Certificate Completed-Pending Issued view
CYSS0600098 乙型肝炎病毒e抗体诊断试剂盒(酶联免疫法) Diagnostic reagent IVD Generic Drug 2007-01-10 北京贝尔生物工程有限公司 Beijing Beier Bioengineering Co Ltd In Approval 2008-12-30 view
CYSB1000050 丙型肝炎病毒抗体诊断试剂盒(酶联免疫法) Diagnostic reagent IVD Supplementary Application 2010-10-26 北京贝尔生物工程有限公司 Beijing Beier Bioengineering Co Ltd In Review 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
CXSS0600085 梅毒螺旋体抗体诊断试剂盒(双抗原夹心法) Diagnostic reagent IVD New Drug Application 2006-09-25 北京贝尔生物工程有限公司 Beijing Beier Bioengineering Co Ltd Certificate Issued 2008-02-22 view
CXSS0700002 破伤风抗体(IgG)诊断试剂盒(酶联免疫法) Diagnostic reagent IVD New Drug Application 2007-03-29 北京贝尔生物工程有限公司 Beijing Beier Bioengineering Co Ltd Certificate Issued 2008-08-07 view
CYSS0600097 乙型肝炎病毒e抗原诊断试剂盒(酶联免疫法) Diagnostic reagent IVD Generic Drug 2007-01-10 北京贝尔生物工程有限公司 Beijing Beier Bioengineering Co Ltd In Approval 2008-12-30 view
CYSB1000052 梅毒螺旋体抗体诊断试剂盒(酶联免疫法) Diagnostic reagent IVD Supplementary Application 2010-10-26 北京贝尔生物工程有限公司 Beijing Beier Bioengineering Co Ltd In Review view
CYSS0500053 丙型肝炎病毒抗体诊断试剂盒(酶联免疫法) Diagnostic reagent IVD Generic Drug 2005-06-10 北京贝尔生物工程有限公司 Beijing Beier Bioengineering Co Ltd Certificate Issued 2006-05-15 view
CYSS0600075 人类免疫缺陷病毒抗体诊断试剂盒(双抗原夹心酶联免疫法) Diagnostic reagent IVD Generic Drug 2006-09-25 北京贝尔生物工程有限公司 Beijing Beier Bioengineering Co Ltd Certificate Issued 2008-07-21 view
CYSS0600095 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 2007-01-10 北京贝尔生物工程有限公司 Beijing Beier Bioengineering Co Ltd In Approval 2010-01-27 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
CYSB1000051 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 2010-10-26 北京贝尔生物工程有限公司 Beijing Beier Bioengineering Co Ltd In Review view
X0406361 人类巨细胞病毒IgM抗体酶联免疫诊断试剂盒 Diagnostic reagent IVD New Drug Application 2004-11-08 北京贝尔生物工程有限公司 Beijing Beier Bioengineering Co Ltd Certificate Issued 2006-05-23 view