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Acceptance No. Drug Name Active Ingredient Dosage Form Classification Submission Acceptance Date Manufacturers Manufacturers Review Status Status Date View
CXSS0500124 EB病毒早期抗原抗体诊断试剂盒(酶联免疫法) Diagnostic reagent IVD New Drug Application 2005-11-10 郑州安图绿科生物工程有限公司 Autobio Diagnostics Co Ltd Certificate Completed-Pending Issued view
CYFB1000029 丙型肝炎病毒抗体诊断试剂盒(酶联免疫法) Diagnostic reagent IVD Supplementary Application 2010-08-16 郑州安图绿科生物工程有限公司 Autobio Diagnostics Co Ltd Certificate Issued 2010-11-12 view
CYSB0800172 丙型肝炎病毒抗体诊断试剂盒(酶联免疫法) Diagnostic reagent Biological Products Supplementary Application 2008-12-12 郑州安图绿科生物工程有限公司 Autobio Diagnostics Co Ltd Certificate Issued 2009-04-08 view
CXSS0500096 乙型肝炎病毒e抗体诊断试剂盒(化学发光法) Diagnostic reagent IVD New Drug Application 2005-08-24 郑州安图绿科生物工程有限公司 Autobio Diagnostics Co Ltd Certificate Issued 2006-06-21 view
CXSS0500095 乙型肝炎病毒e抗原诊断试剂盒(化学发光法) Diagnostic reagent IVD New Drug Application 2005-08-24 郑州安图绿科生物工程有限公司 Autobio Diagnostics Co Ltd Certificate Issued 2006-06-21 view
CXSS0500097 乙型肝炎病毒核心抗体诊断试剂盒(化学发光法) Diagnostic reagent IVD New Drug Application 2005-08-24 郑州安图绿科生物工程有限公司 Autobio Diagnostics Co Ltd Approval Completed-Pending Certificated view
CXSS0500153 乙型肝炎病毒表面抗体诊断试剂盒(化学发光法) Diagnostic reagent IVD New Drug Application 2005-12-07 郑州安图绿科生物工程有限公司 Autobio Diagnostics Co Ltd Approval Completed-Pending Certificated view
CYFB1000031 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 2010-08-16 郑州安图绿科生物工程有限公司 Autobio Diagnostics Co Ltd Certificate Issued 2010-11-12 view
CYSB0800171 乙型肝炎病毒表面抗原诊断试剂盒(酶联免疫法) Diagnostic reagent Biological Products Supplementary Application 2008-12-12 郑州安图绿科生物工程有限公司 Autobio Diagnostics Co Ltd Certificate Issued 2009-04-08 view
CYFB1000033 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 2010-08-16 郑州安图绿科生物工程有限公司 Autobio Diagnostics Co Ltd Certificate Issued 2010-11-12 view
CYSB0800173 人类免疫缺陷病毒抗体诊断试剂盒(双抗原夹心酶联免疫法) Diagnostic reagent Biological Products Supplementary Application 2008-12-12 郑州安图绿科生物工程有限公司 Autobio Diagnostics Co Ltd Certificate Issued 2009-04-08 view
CXSS0700026 前列腺特异性抗原定量检测试剂盒(化学发光法) Diagnostic reagent IVD New Drug Application 2007-03-02 郑州安图绿科生物工程有限公司 Autobio Diagnostics Co Ltd Approval Completed-Pending Certificated view
CYFB1100002 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 郑州安图绿科生物工程有限公司 Autobio Diagnostics Co Ltd Certificate Issued 2014-06-05 view
CYFB1000032 梅毒甲苯胺红不加热血清试验诊断试剂 Diagnostic reagent IVD Supplementary Application 2010-08-16 郑州安图绿科生物工程有限公司 Autobio Diagnostics Co Ltd Certificate Issued 2011-03-25 view
CXSS0700023 癌抗原15-3定量检测试剂盒(化学发光法) Diagnostic reagent IVD New Drug Application 2007-03-23 郑州安图绿科生物工程有限公司 Autobio Diagnostics Co Ltd Approval Completed-Pending Certificated view
CXSS0700024 癌抗原19-9定量检测试剂盒(化学发光法) Diagnostic reagent IVD New Drug Application 2007-03-02 郑州安图绿科生物工程有限公司 Autobio Diagnostics Co Ltd Approval Completed-Pending Certificated view
CXSS0700022 癌抗原50定量检测试剂盒(化学发光法) Diagnostic reagent IVD New Drug Application 2007-03-02 郑州安图绿科生物工程有限公司 Autobio Diagnostics Co Ltd Approval Completed-Pending Certificated view
CXSS0700025 癌胚抗原化学发光定量检测试剂盒 Diagnostic reagent IVD New Drug Application 2007-03-02 郑州安图绿科生物工程有限公司 Autobio Diagnostics Co Ltd Approval Completed-Pending Certificated view