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Acceptance No. Drug Name Active Ingredient Dosage Form Classification Submission Acceptance Date Manufacturers Manufacturers Review Status Status Date View
X0407269 EB病毒IgA抗体酶联免疫吸附法诊断试剂盒 Diagnostic reagent IVD New Drug Application 2004-12-02 中山生物工程有限公司 Zhongshan BIO-TECH Co Ltd Certificate Issued 2005-10-08 view
CXSB0500169 EB病毒IgA抗体酶联免疫吸附法诊断试剂盒 Diagnostic reagent IVD Supplementary Application 2006-02-13 中山生物工程有限公司 Zhongshan BIO-TECH Co Ltd Certificate Completed-Pending Issued view
CYFB1100057 丙型肝炎病毒抗体诊断试剂盒(酶联免疫法) Diagnostic reagent IVD Supplementary Application 2011-05-16 中山生物工程有限公司 Zhongshan BIO-TECH Co Ltd Certificate Issued 2011-10-20 view
X0400720 乙型肝炎病毒(HBV)快速基因定量试剂盒 Diagnostic reagent IVD New Drug Application 2004-10-08 中山生物工程有限公司 Zhongshan BIO-TECH Co Ltd Pending Approval 2005-05-07 view
CXHS0500007 乙型肝炎病毒表面抗体定量检测试剂盒(时间分辨荧光免疫分析法) Diagnostic reagent IVD New Drug Application 2005-02-22 中山生物工程有限公司 Zhongshan BIO-TECH Co Ltd Certificate Issued 2005-12-15 view
CXSS0500004 乙型肝炎病毒表面抗原定量检测试剂盒(时间分辨荧光免疫分析法) Diagnostic reagent IVD New Drug Application 2005-02-22 中山生物工程有限公司 Zhongshan BIO-TECH Co Ltd Certificate Issued 2005-12-15 view
CYFB1100060 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 2011-05-16 中山生物工程有限公司 Zhongshan BIO-TECH Co Ltd Certificate Issued 2011-10-20 view
CSS20020035 人类免疫缺陷病毒抗体诊断试剂盒 Diagnostic reagent IVD(4) New Drug Application 2002-08-01 中山生物工程有限公司 Zhongshan BIO-TECH Co Ltd Certificate Issued 2003-06-20 view
CYFB1100059 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 IVD Supplementary Application 2011-05-16 中山生物工程有限公司 Zhongshan BIO-TECH Co Ltd Certificate Issued 2011-08-03 view
CYFB1100058 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 2011-05-16 中山生物工程有限公司 Zhongshan BIO-TECH Co Ltd Certificate Issued 2011-10-20 view
CXSS0500056 登革病毒IgG 抗体酶联免疫诊断试剂盒 Diagnostic reagent IVD New Drug Application 2005-07-01 中山生物工程有限公司 Zhongshan BIO-TECH Co Ltd Certificate Issued 2007-01-11 view
CXSS0500055 登革病毒IgM 抗体酶联免疫诊断试剂盒 Diagnostic reagent IVD New Drug Application 2005-07-01 中山生物工程有限公司 Zhongshan BIO-TECH Co Ltd Certificate Issued 2007-01-11 view
X0404311 聚凝胺一步法(OSPT)配血试剂盒 Diagnostic reagent IVD New Drug Application 2004-08-01 中山生物工程有限公司 Zhongshan BIO-TECH Co Ltd Certificate Issued 2006-12-05 view
X0404317 聚凝胺三步法(TSPT)配血试剂盒 Diagnostic reagent IVD New Drug Application 2004-08-05 中山生物工程有限公司 Zhongshan BIO-TECH Co Ltd Certificate Issued 2006-12-05 view