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Acceptance No. Drug Name Active Ingredient Dosage Form Classification Submission Acceptance Date Manufacturers Manufacturers Review Status Status Date View
CYSB1000037 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 2010-03-12 英科新创(厦门)科技有限公司 InTec Products INC Certificate Issued 2010-07-05 view
Y0405207 梅毒螺旋体抗体诊断试剂盒 Diagnostic reagent IVD Supplementary Application 2004-07-21 英科新创(厦门)科技有限公司 InTec Products INC Certificate Issued 2004-12-06 view
CXSS0600121 梅毒螺旋体抗体诊断试剂盒(双抗原夹心时间分辨免疫荧光分析法) Diagnostic reagent IVD New Drug Application 2006-11-30 苏州新波生物技术有限公司 Suzhou SYM-BIO Life Science Co Ltd;Ruifudi Biomedical (Shanghai) Co Ltd In Approval 2008-11-27 view
JXSS0500023 梅毒螺旋体抗体诊断试剂盒(酶联免疫法) Diagnostic reagent IVD Import Drug Application 2005-08-19 生物梅里埃公司 Biomerieux Bv;DIESSE Diagnostica Senese SpA Certificate Issued 2007-01-10 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
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
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
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
Y0413779 梅毒螺旋体抗体诊断试剂盒(酶联免疫法) Diagnostic reagent IVD Generic Drug 2004-11-12 潍坊三维生物工程集团有限公司 Weifang Sanwei Bioengineering Group Co Ltd Certificate Issued 2006-01-19 view
CYFB1000070 梅毒螺旋体抗体诊断试剂盒(酶联免疫法) Diagnostic reagent IVD Supplementary Application 2010-12-08 潍坊三维生物工程集团有限公司 Weifang Sanwei Bioengineering Group Co Ltd Certificate Issued 2011-03-25 view
CXFS1000004 梅毒螺旋体抗体诊断试剂盒(酶联免疫法) Diagnostic reagent IVD New Drug Application 2011-02-21 深圳迈瑞生物医疗电子股份有限公司 Shenzhen Mindray Bio-Medical Electronics Co Ltd Certificate Issued 2012-05-10 view
CYSS0600034 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 Generic Drug 2006-06-02 深圳市华美圣科生物工程有限公司 Shenzhen Huamei Shengke Biologic Engineering Co Ltd Certificate Issued 2009-06-16 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
CYFS0600018 梅毒螺旋体抗体诊断试剂盒(酶联免疫法) Diagnostic reagent IVD Generic Drug 2006-11-22 河北医科大学生物医学工程中心 Shijiazhuang Kaida Bioengineering Co Ltd Certificate Issued 2008-02-22 view
CXSS0600093 梅毒螺旋体抗体诊断试剂盒(双抗原夹心化学发光法) Diagnostic reagent IVD New Drug Application 2006-11-06 威海威高生物科技有限公司 Weihai Weigao BIOTECHNOLOGY Co Ltd Approval Completed-Pending Certificated view
CYSB1000054 梅毒螺旋体抗体诊断试剂盒(酶联免疫双抗原夹心法) Diagnostic reagent IVD Supplementary Application 2010-10-27 北京金豪制药股份有限公司 Beijing Kinghawk Pharmaceutical Co Ltd In Review view
CXSS0600085 梅毒螺旋体抗体诊断试剂盒(双抗原夹心法) Diagnostic reagent IVD New Drug Application 2006-09-25 北京贝尔生物工程有限公司 Beijing Beier Bioengineering Co Ltd Certificate Issued 2008-02-22 view
CYSB1000052 梅毒螺旋体抗体诊断试剂盒(酶联免疫法) Diagnostic reagent IVD Supplementary Application 2010-10-26 北京贝尔生物工程有限公司 Beijing Beier Bioengineering Co Ltd In Review view
CXSB0700083 梅毒螺旋体抗体诊断试剂盒(化学发光法) Diagnostic reagent IVD Supplementary Application 2008-02-18 北京科美东雅生物技术有限公司 Beijing Chemclin Biotech Co Ltd Certificate Issued 2008-09-01 view
CYSS0800010 梅毒螺旋体抗体诊断试剂盒(双抗原夹心法) Diagnostic reagent IVD Generic Drug 2008-08-28 北京科卫临床诊断试剂有限公司 Beijing Kewei Clinical Diagnostic Reagent Inc Certificate Issued 2009-12-21 view