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Acceptance No. Drug Name Active Ingredient Dosage Form Classification Submission Acceptance Date Manufacturers Manufacturers Review Status Status Date View
CYSB1000053 丙型肝炎病毒抗体诊断试剂盒(酶联免疫法) Diagnostic reagent IVD Supplementary Application 2010-10-27 北京金豪制药股份有限公司 Beijing Kinghawk Pharmaceutical Co Ltd In Review view
CYSB1000056 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 2010-10-27 北京金豪制药股份有限公司 Beijing Kinghawk Pharmaceutical Co Ltd In Review view
CYSB1000055 人类免疫缺陷病毒(HIV)1+2型抗体诊断试剂盒(酶联免疫双抗原夹心法) Diagnostic reagent IVD Supplementary Application 2010-10-27 北京金豪制药股份有限公司 Beijing Kinghawk Pharmaceutical Co Ltd In Review view
CYSB1000054 梅毒螺旋体抗体诊断试剂盒(酶联免疫双抗原夹心法) Diagnostic reagent IVD Supplementary Application 2010-10-27 北京金豪制药股份有限公司 Beijing Kinghawk Pharmaceutical Co Ltd In Review view
CYFB1000078 梅毒甲苯胺红不加热血清试验诊断试剂 Diagnostic reagent IVD Supplementary Application 2011-02-12 北京金豪制药股份有限公司 Beijing Kinghawk Pharmaceutical Co Ltd Certificate Issued 2011-06-10 view
CYFB1000076 抗A抗B血型定型试剂(单克隆抗体) Diagnostic reagent IVD Supplementary Application 2011-02-12 北京金豪制药股份有限公司 Beijing Kinghawk Pharmaceutical Co Ltd Certificate Issued 2011-06-10 view
CYSS1100001 人类免疫缺陷病毒抗原抗体诊断试剂盒(酶联免疫法) Diagnostic reagent IVD Generic Drug 2011-09-29 北京金豪制药股份有限公司 Beijing Kinghawk Pharmaceutical Co Ltd Certificate Issued 2012-05-10 view
CYFB1700009 抗A抗B血型定型试剂(单克隆抗体) Diagnostic reagent IVD Supplementary Application 2018-08-02 北京金豪制药股份有限公司 Beijing Kinghawk Pharmaceutical Co Ltd Certificate Issued 2019-04-22 view