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Acceptance No. Drug Name Active Ingredient Dosage Form Classification Submission Acceptance Date Manufacturers Manufacturers Review Status Status Date View
CYSB0600110 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 2007-03-02 北京金豪制药有限公司 Beijing Kinghawk Pharmaceutical Co Ltd Certificate Issued 2008-12-22 view
CXSS0500167 乙型肝炎病毒核酸扩增荧光定量检测试剂盒 Diagnostic reagent IVD New Drug Application 2006-01-05 北京金豪制药有限公司 Beijing Kinghawk Pharmaceutical Co Ltd Certificate Issued 2008-11-28 view
CYSB0700028 乙型肝炎病毒e抗体诊断试剂盒(酶联免疫法) Diagnostic reagent IVD Supplementary Application 2007-06-27 北京金豪制药有限公司 Beijing Kinghawk Pharmaceutical Co Ltd Certificate Issued 2008-09-01 view
CXSS0600051 乙型肝炎病毒核酸扩增荧光定量检测试剂盒 Diagnostic reagent IVD New Drug Application 2006-05-25 北京金豪制药有限公司 Beijing Kinghawk Pharmaceutical Co Ltd In Approval 2008-08-07 view
CXSS0600011 布鲁氏菌病抗体快速检测试剂(胶体金法) Diagnostic reagent IVD New Drug Application 2006-02-13 北京金豪制药有限公司 Beijing Kinghawk Pharmaceutical Co Ltd;Institute of Microbiology and Epidemiology Academy of Military Medical Sciences PLA In Approval 2008-07-16 view
CXSS0600012 类鼻疽抗体快速检测试剂(胶体金法) Diagnostic reagent IVD New Drug Application 2006-02-13 北京金豪制药有限公司 Beijing Kinghawk Pharmaceutical Co Ltd;Institute of Microbiology and Epidemiology Academy of Military Medical Sciences PLA In Approval 2008-07-16 view
CXSS0600017 土拉热抗体快速检测试剂(胶体金法) Diagnostic reagent IVD New Drug Application 2006-02-13 北京金豪制药有限公司 Beijing Kinghawk Pharmaceutical Co Ltd;Institute of Microbiology and Epidemiology Academy of Military Medical Sciences PLA In Approval 2008-07-16 view
CXSS0600016 炭疽抗体快速检测试剂(胶体金法) Diagnostic reagent IVD New Drug Application 2006-02-13 北京金豪制药有限公司 Beijing Kinghawk Pharmaceutical Co Ltd;Institute of Microbiology and Epidemiology Academy of Military Medical Sciences PLA In Approval 2008-07-16 view
CXSS0600060 鼻疽抗体快速检测试剂(胶体金法) Diagnostic reagent IVD New Drug Application 2006-06-02 北京金豪制药有限公司 Beijing Kinghawk Pharmaceutical Co Ltd;Institute of Microbiology and Epidemiology Academy of Military Medical Sciences PLA In Approval 2008-07-16 view
CXSS0600014 鼠疫抗体快速检测试剂(胶体金法) Diagnostic reagent IVD New Drug Application 2006-02-13 北京金豪制药有限公司 Beijing Kinghawk Pharmaceutical Co Ltd;Institute of Microbiology and Epidemiology Academy of Military Medical Sciences PLA In Approval 2008-07-16 view
CXSB0500167 EB病毒TK/IgG抗体诊断试剂盒(酶联免疫法) Diagnostic reagent IVD Supplementary Application 2005-12-08 北京金豪制药有限公司 Beijing Kinghawk Pharmaceutical Co Ltd Certificate Issued 2008-04-28 view
X0408226 IgG抗-D血型诊断试剂 Diagnostic reagent IVD New Drug Application 2005-01-06 北京金豪制药有限公司 Beijing Kinghawk Pharmaceutical Co Ltd Certificate Issued 2007-04-20 view
X0407897 IgM抗-D血型诊断试剂 Diagnostic reagent IVD New Drug Application 2004-12-30 北京金豪制药有限公司 Beijing Kinghawk Pharmaceutical Co Ltd Certificate Issued 2006-12-05 view
CYSS0500096 抗A、抗B血型定型试剂(单克隆抗体) Diagnostic reagent IVD Generic Drug 2005-10-25 北京金豪制药有限公司 Beijing Kinghawk Pharmaceutical Co Ltd Certificate Issued 2006-05-29 view
Y0405046 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 2004-07-15 北京金豪制药有限公司 Beijing Kinghawk Pharmaceutical Co Ltd Certificate Issued 2005-11-02 view
CYSS0500019 梅毒甲苯胺红不加热血清试验诊断试剂盒(TRUST) Diagnostic reagent IVD Generic Drug 2005-03-10 北京金豪制药有限公司 Beijing Kinghawk Pharmaceutical Co Ltd Certificate Issued 2005-10-27 view
CXSS0500017 EB 病毒TK/IgG抗体诊断试剂盒(酶联免疫法) Diagnostic reagent IVD New Drug Application 2005-03-02 北京金豪制药有限公司 Beijing Kinghawk Pharmaceutical Co Ltd Certificate Issued 2005-10-18 view
Y0402576 乙型肝炎病毒表面抗体诊断试剂盒(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 2005-03-21 view
Y0402574 乙型肝炎病毒e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 2005-03-03 view
Y0402575 乙型肝炎病毒e抗体诊断试剂盒(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 2005-03-03 view