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Acceptance No. Drug Name Active Ingredient Dosage Form Classification Submission Acceptance Date Manufacturers Manufacturers Review Status Status Date View
CXSS0600024 ABO血型反定型试剂(人血红细胞) Diagnostic reagent IVD New Drug Application 2006-02-24 北京金豪制药有限公司 Beijing Kinghawk Pharmaceutical Co Ltd Certificate Completed-Pending Issued view
CXSS0600009 A型肉毒毒素快速检测试剂(胶体金法) Botulinum Toxin Type A Diagnostic reagent IVD New Drug Application 2006-02-13 北京金豪制药有限公司 Beijing Kinghawk Pharmaceutical Co Ltd Certificate Completed-Pending Issued view
CXSS0600010 B型葡萄球菌肠毒素快速检测试剂(胶体金法) Other IVD New Drug Application 2006-02-13 北京金豪制药有限公司 Beijing Kinghawk Pharmaceutical Co Ltd Certificate Completed-Pending Issued 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
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
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
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
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
CXSS0600032 乙型肝炎病毒前S抗原诊断试剂盒(酶联免疫法) Diagnostic reagent IVD New Drug Application 2006-03-17 北京金豪制药有限公司 Beijing Kinghawk Pharmaceutical Co Ltd Approval Completed-Pending Certificated 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
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
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
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
Y0402577 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 2004-11-29 北京金豪制药有限公司 Beijing Kinghawk Pharmaceutical Co Ltd Certificate Issued 2005-02-25 view
Y0403706 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 2004-11-29 北京金豪制药有限公司 Beijing Kinghawk Pharmaceutical Co Ltd Certificate Issued 2005-02-25 view
CSb01072 人类免疫缺陷病毒(HIV)1+2型抗体酶联免疫法诊断试剂盒(双抗原夹心法) Diagnostic reagent IVD(4) Supplementary Application 2001-11-19 北京金豪制药有限公司 Beijing Kinghawk Pharmaceutical Co Ltd Approval Completed-Pending Certificated 2002-06-14 view
CSS01018 人类免疫缺陷病毒抗体诊断试剂盒(胶体金法) Diagnostic reagent IVD(4) New Drug Application 2001-05-14 北京金豪制药有限公司 Beijing Kinghawk Pharmaceutical Co Ltd Certificate Issued 2003-03-20 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