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Acceptance No. Drug Name Active Ingredient Dosage Form Classification Submission Acceptance Date Manufacturers Manufacturers Review Status Status Date View
CXSS0500022 人类免疫缺陷病毒1+2型抗体/P24抗原诊断试剂盒(夹心酶联免疫法) Diagnostic reagent IVD New Drug Application 2005-03-24 北京科卫临床诊断试剂有限公司 Beijing Kewei Clinical Diagnostic Reagent Inc Certificate Issued 2006-06-08 view
CXSS0500024 丙型肝炎病毒抗体诊断试剂盒(双抗原夹心法) Diagnostic reagent IVD New Drug Application 2005-03-24 北京科卫临床诊断试剂有限公司 Beijing Kewei Clinical Diagnostic Reagent Inc Certificate Issued 2014-08-26 view
CXSS0500041 乙肝五项金标测试板 Diagnostic reagent IVD New Drug Application 2005-05-02 北京科卫临床诊断试剂有限公司 Beijing Kewei Clinical Diagnostic Reagent Inc Certificate Issued 2006-07-14 view
CYSS0600012 戊型肝炎病毒IgM抗体诊断试剂盒(酶联免疫捕获法) Diagnostic reagent IVD Generic Drug 2006-03-17 北京科卫临床诊断试剂有限公司 Beijing Kewei Clinical Diagnostic Reagent Inc In Approval 2008-08-22 view
CYSS0800010 梅毒螺旋体抗体诊断试剂盒(双抗原夹心法) Diagnostic reagent IVD Generic Drug 2008-08-28 北京科卫临床诊断试剂有限公司 Beijing Kewei Clinical Diagnostic Reagent Inc Certificate Issued 2009-12-21 view
CYSB1000062 梅毒螺旋体抗体诊断试剂盒(双抗原夹心法) Diagnostic reagent IVD Supplementary Application 2010-10-26 北京科卫临床诊断试剂有限公司 Beijing Kewei Clinical Diagnostic Reagent Inc In Review view
CYSB1000059 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 北京科卫临床诊断试剂有限公司 Beijing Kewei Clinical Diagnostic Reagent Inc In Review view
CYSB1000058 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 2010-10-26 北京科卫临床诊断试剂有限公司 Beijing Kewei Clinical Diagnostic Reagent Inc In Review view
CYSB1000061 梅毒快速血浆反应素诊断试剂盒 Diagnostic reagent IVD Supplementary Application 2010-10-27 北京科卫临床诊断试剂有限公司 Beijing Kewei Clinical Diagnostic Reagent Inc In Review view
CYSB1000060 人类免疫缺陷病毒抗体(1+2型)/P24抗原(1型)诊断试剂盒(酶联免疫法) Diagnostic reagent IVD Supplementary Application 2010-10-27 北京科卫临床诊断试剂有限公司 Beijing Kewei Clinical Diagnostic Reagent Inc In Review view