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Acceptance No. Drug Name Active Ingredient Dosage Form Classification Submission Acceptance Date Manufacturers Manufacturers Review Status Status Date View
X0304128 非典型肺炎(SARS)病毒抗体酶联免疫诊断试剂盒(双抗原夹心法) Diagnostic reagent IVD New Drug Application 2004-10-12 河南华美生物工程有限公司 Henan Huamei Biological Engineering Co Ltd Certificate Issued 2006-08-24 view
CYFB0900033 梅毒螺旋体抗体酶联免疫诊断试剂盒(双抗原夹心法) Diagnostic reagent IVD Supplementary Application 2009-04-23 河南华美生物工程有限公司 Henan Huamei Biological Engineering Co Ltd Certificate Issued 2010-05-19 view
CYFB1100004 梅毒螺旋体抗体诊断试剂盒(酶联免疫法) Diagnostic reagent IVD Supplementary Application 2011-02-10 河南华美生物工程有限公司 Henan Huamei Biological Engineering Co Ltd Certificate Issued 2011-12-13 view
CYFB0900034 戊型肝炎病毒IgG抗体酶联免疫测定试剂盒 Diagnostic reagent IVD Supplementary Application 2009-05-12 河南华美生物工程有限公司 Henan Huamei Biological Engineering Co Ltd In Approval 2012-03-01 view
CSS20020030 人类免疫缺陷病毒(HIV)I+II型抗体胶体金检测试纸条 Diagnostic reagent Biological Products(2) New Drug Application 2002-07-10 河南省生物工程技术研究中心河南华美生物工程有限公司 Certificate Issued 2003-05-30 view
CYFB1100005 人类免疫缺陷病毒抗体诊断试剂盒(酶联免疫法) Diagnostic reagent IVD Supplementary Application 2011-02-10 河南华美生物工程有限公司 Henan Huamei Biological Engineering Co Ltd Certificate Issued 2011-08-03 view
X0301951 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 Supplementary Application 2004-03-02 河南华美生物工程有限公司 Henan Huamei Biological Engineering Co Ltd Certificate Issued 2005-03-25 view
CYSS0700015 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 2007-08-22 河南华美生物工程有限公司 Henan Huamei Biological Engineering Co Ltd Certificate Issued 2008-12-22 view
CYFB1100019 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 2011-02-28 华美生物工程有限公司 SINO-AMERICAN BIOTECHNOLOGY Co Ltd Certificate Issued 2011-08-03 view
CYSS0700016 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 2007-08-22 河南华美生物工程有限公司 Henan Huamei Biological Engineering Co Ltd Pending Approval view
CYSS0700017 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 2007-08-22 河南华美生物工程有限公司 Henan Huamei Biological Engineering Co Ltd Pending Approval view
CYSS0700014 乙型肝炎病毒e抗原诊断试剂盒(酶联免疫法) Diagnostic reagent IVD Generic Drug 2007-08-22 河南华美生物工程有限公司 Henan Huamei Biological Engineering Co Ltd Pending Approval view
CYSS0700005 乙型肝炎病毒e抗体诊断试剂盒(酶联免疫法) Diagnostic reagent IVD Generic Drug 2007-06-07 河南华美生物工程有限公司 Henan Huamei Biological Engineering Co Ltd Certificate Issued 2008-12-22 view
CYFB1100003 丙型肝炎病毒抗体诊断试剂盒(酶联免疫法) Diagnostic reagent IVD Supplementary Application 2011-02-10 河南华美生物工程有限公司 Henan Huamei Biological Engineering Co Ltd Certificate Issued 2011-06-30 view
CYFB0900035 丙型肝炎病毒抗体诊断试剂盒(酶联免疫法) Diagnostic reagent IVD Supplementary Application 2009-05-12 河南华美生物工程有限公司 Henan Huamei Biological Engineering Co Ltd Certificate Issued 2009-07-13 view