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Acceptance No. Drug Name Active Ingredient Dosage Form Classification Submission Acceptance Date Manufacturers Manufacturers Review Status Status Date 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
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