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Acceptance No. Drug Name Active Ingredient Dosage Form Classification Submission Acceptance Date Manufacturers Manufacturers Review Status Status Date View
Y0304008 甲型肝炎病毒IgM抗体酶联免疫测定试剂盒 Diagnostic reagent IVD Generic Drug 2004-07-06 珠海丽珠试剂有限公司 Zhuhai Livzon Diagnostics INC Certificate Issued 2004-11-16 view
CYFB0900040 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 2009-07-24 珠海丽珠试剂股份有限公司 Zhuhai Livzon Diagnostics INC Certificate Issued 2010-11-23 view
CYFB1000025 梅毒螺旋体抗体诊断试剂盒(双抗原夹心酶联免疫法) Diagnostic reagent IVD Supplementary Application 2010-08-25 珠海丽珠试剂股份有限公司 Zhuhai Livzon Diagnostics INC Certificate Issued 2010-11-12 view
CYFB1000028 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 2010-08-25 珠海丽珠试剂股份有限公司 Zhuhai Livzon Diagnostics INC Certificate Issued 2010-11-12 view
CYFB1000026 丙型肝炎病毒抗体诊断试剂盒(酶联免疫法) Diagnostic reagent IVD Supplementary Application 2010-08-25 珠海丽珠试剂股份有限公司 Zhuhai Livzon Diagnostics INC Certificate Issued 2010-11-12 view
CXFS1000003 人类免疫缺陷病毒抗原抗体诊断试剂盒(酶联免疫法) Diagnostic reagent IVD New Drug Application 2011-02-12 珠海丽珠试剂股份有限公司 Zhuhai Livzon Diagnostics INC Certificate Issued 2012-08-28 view
CYFB1200067 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 2012-07-06 珠海丽珠试剂股份有限公司 Zhuhai Livzon Diagnostics INC Certificate Issued 2012-10-30 view
CYFB1200068 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 2012-07-06 珠海丽珠试剂股份有限公司 Zhuhai Livzon Diagnostics INC Certificate Issued 2012-10-30 view
CYFB1200069 丙型肝炎病毒抗体诊断试剂盒(酶联免疫法) Diagnostic reagent IVD Supplementary Application 2012-07-06 珠海丽珠试剂股份有限公司 Zhuhai Livzon Diagnostics INC Certificate Issued 2012-10-30 view
CYFB1200066 梅毒螺旋体抗体诊断试剂盒(酶联免疫法) Diagnostic reagent IVD Supplementary Application 2012-07-06 珠海丽珠试剂股份有限公司 Zhuhai Livzon Diagnostics INC Certificate Issued 2012-10-30 view
CYFB1300005 人类免疫缺陷病毒抗原抗体诊断试剂盒(酶联免疫法) Diagnostic reagent IVD Supplementary Application 2013-07-22 珠海丽珠试剂股份有限公司 Zhuhai Livzon Diagnostics INC Certificate Issued 2013-10-23 view
CYFB1300006 梅毒螺旋体抗体诊断试剂盒(酶联免疫法) Diagnostic reagent IVD Supplementary Application 2013-07-22 珠海丽珠试剂股份有限公司 Zhuhai Livzon Diagnostics INC Certificate Issued 2013-10-23 view
CXFS1400003 丙型肝炎病毒抗体诊断试剂盒(酶联免疫法) Diagnostic reagent IVD New Drug Application 2014-07-17 珠海丽珠试剂股份有限公司 Zhuhai Livzon Diagnostics INC Certificate Issued 2014-12-18 view
CYSB1500112 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 2015-06-29 珠海丽珠试剂股份有限公司 Zhuhai Livzon Diagnostics INC Certificate Issued 2016-02-03 view
CYSB1500111 梅毒螺旋体抗体诊断试剂盒(酶联免疫法) Diagnostic reagent IVD Supplementary Application 2015-06-29 珠海丽珠试剂股份有限公司 Zhuhai Livzon Diagnostics INC Certificate Issued 2016-02-03 view
CYSB1500110 人类免疫缺陷病毒抗原抗体诊断试剂盒(酶联免疫法) Diagnostic reagent IVD Supplementary Application 2015-06-29 珠海丽珠试剂股份有限公司 Zhuhai Livzon Diagnostics INC Certificate Issued 2016-02-03 view
CYSB1500109 丙型肝炎病毒抗体诊断试剂盒(酶联免疫法) Diagnostic reagent IVD Supplementary Application 2015-06-29 珠海丽珠试剂股份有限公司 Zhuhai Livzon Diagnostics INC Certificate Issued 2016-02-03 view
CYSB1500108 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 2015-06-29 珠海丽珠试剂股份有限公司 Zhuhai Livzon Diagnostics INC Certificate Issued 2016-02-03 view
CYSB1700228 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 2017-12-14 珠海丽珠试剂股份有限公司 Zhuhai Livzon Diagnostics INC Certificate Issued 2018-05-08 view
CXSS1800028 乙型肝炎病毒、 丙型肝炎病毒 、人类免疫缺陷病毒(1+2型)核酸检测试剂盒(PCR-荧光法) Diagnostic reagent IVD(15) New Drug Application 2018-12-04 珠海丽珠试剂股份有限公司 Zhuhai Livzon Diagnostics INC Certificate Issued 2019-12-13 view