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Acceptance No. Drug Name Active Ingredient Dosage Form Classification Submission Acceptance Date Manufacturers Manufacturers Review Status Status Date View
JXSZ0500004 乙肝e抗原微粒子酶免疫分析诊断试剂盒 Diagnostic reagent IVD License Renew 2005-02-22 雅培德国制药有限公司 Abbott Gmbh & Co KG Certificate Issued 2006-01-06 view
JXSZ0500003 丙肝抗体微粒子酶免疫分析诊断试剂盒 Diagnostic reagent IVD License Renew 2005-02-22 雅培德国制药有限公司 Abbott Gmbh & Co KG Certificate Issued 2006-05-30 view
JXSZ0500002 乙肝核心抗体微粒子酶免疫分析诊断试剂盒 Diagnostic reagent IVD License Renew 2005-02-22 雅培德国制药有限公司 Abbott Gmbh & Co KG Certificate Issued 2006-01-06 view
JXSZ0500001 乙肝表面抗原微粒子酶免疫分析诊断试剂盒 Diagnostic reagent IVD License Renew 2005-02-22 雅培德国制药有限公司 Abbott Gmbh & Co KG Certificate Issued 2006-01-06 view
JXSZ0500006 乙肝e抗体微粒子酶免疫分析诊断试剂盒 Diagnostic reagent IVD License Renew 2005-02-22 雅培德国制药有限公司 Abbott Gmbh & Co KG Certificate Issued 2006-01-06 view
JXSZ0500005 乙肝表面抗体微粒子酶免疫分析诊断试剂盒 Diagnostic reagent IVD License Renew 2005-02-22 雅培德国制药有限公司 Abbott Gmbh & Co KG Certificate Issued 2006-01-06 view
JXSS0500002 人类免疫缺陷病毒抗原/抗体联合微粒子酶免疫分析诊断试剂盒 Diagnostic reagent IVD Import Drug Application 2005-02-25 雅培德国制药有限公司 Abbott Gmbh & Co KG Certificate Issued 2008-07-21 view
JXSZ0500008 乙肝e抗体化学发光法免疫分析诊断试剂盒及乙肝e抗体质控液和乙肝e抗体定标液 Diagnostic reagent IVD License Renew 2005-08-11 雅培德国制药有限公司 Abbott Gmbh & Co KG Certificate Completed-Pending Issued 2006-06-28 view
JXSZ0500007 乙肝e抗原化学发光法免疫分析诊断试剂包及乙肝e抗原定标液和乙肝e抗原质控液 Diagnostic reagent IVD License Renew 2005-08-11 雅培德国制药有限公司 Abbott Gmbh & Co KG Certificate Issued 2006-12-26 view
JXSZ0500009 乙肝表面抗原确认化学发光法免疫分析试剂及乙肝表面抗原确认定标液和乙肝表面抗原确认质控液 Diagnostic reagent IVD License Renew 2005-08-17 雅培德国制药有限公司 Abbott Gmbh & Co KG Certificate Issued 2006-12-05 view
JXSZ0500015 人类免疫缺陷病毒抗原/抗体联合化学发光法免疫分析诊断试剂及人类免疫缺陷病毒抗原/抗体联合定标液和人类免疫缺陷病毒抗原/抗体联合质控液 Diagnostic reagent IVD License Renew 2005-08-17 雅培德国制药有限公司 Abbott Gmbh & Co KG Certificate Issued 2009-06-19 view
JXSZ0500014 乙肝表面抗原化学发光法免疫分析试剂及乙肝表面抗原定标液和乙肝表面抗原质控液 Diagnostic reagent IVD License Renew 2005-08-17 雅培德国制药有限公司 Abbott Gmbh & Co KG Certificate Completed-Pending Issued 2006-11-27 view
JXSZ0500010 丙肝抗体化学发光法免疫分析诊断试剂及丙肝抗体定标液和丙肝抗体质控液 Diagnostic reagent IVD License Renew 2005-08-17 雅培德国制药有限公司 Abbott Gmbh & Co KG Certificate Completed-Pending Issued 2006-11-27 view
JXSZ0500013 甲肝抗体IgM化学发光法免疫分析诊断试剂及甲肝抗体IgM定标液和质控液 Diagnostic reagent IVD License Renew 2005-08-17 雅培德国制药有限公司 Abbott Gmbh & Co KG Certificate Completed-Pending Issued 2006-11-27 view
JXSZ0500012 甲肝抗体化学发光法免疫分析诊断试剂及甲肝抗体定标液和甲肝抗体质控液 Diagnostic reagent IVD License Renew 2005-08-17 雅培德国制药有限公司 Abbott Gmbh & Co KG Certificate Completed-Pending Issued 2006-10-25 view
JXSZ0500011 乙肝核心抗体IgM化学发光法免疫分析诊断试剂及乙肝核心抗体IgM定标液和乙肝核心抗体IgM质控液 Diagnostic reagent IVD License Renew 2005-08-17 雅培德国制药有限公司 Abbott Gmbh & Co KG Certificate Completed-Pending Issued 2006-11-27 view
JXSS0600035 甲型肝炎病毒IgM抗体诊断试剂盒(微粒子酶联免疫法) Diagnostic reagent IVD Import Drug Application 2006-09-18 雅培德国制药有限公司 Abbott Gmbh & Co KG Certificate Issued 2008-07-21 view
JXSS0600034 甲型肝炎病毒抗体诊断试剂盒(微粒子酶联免疫法) Diagnostic reagent IVD Import Drug Application 2006-09-18 雅培德国制药有限公司 Abbott Gmbh & Co KG Certificate Issued 2008-07-21 view
JXSS0700025 弓形体IgM检测试剂盒(微粒子酶免法) Diagnostic reagent IVD Import Drug Application 2007-04-11 雅培德国制药有限公司 Abbott Gmbh & Co KG Certificate Completed-Pending Issued view
JXSS0700026 弓形体IgG检测试剂盒(微粒子酶免法) Diagnostic reagent IVD Import Drug Application 2007-04-11 雅培德国制药有限公司 Abbott Gmbh & Co KG Certificate Completed-Pending Issued 2010-09-30 view