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Acceptance No. Drug Name Active Ingredient Dosage Form Classification Submission Acceptance Date Manufacturers Manufacturers Review Status Status Date 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
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
CYSB1000062 梅毒螺旋体抗体诊断试剂盒(双抗原夹心法) Diagnostic reagent IVD Supplementary Application 2010-10-26 北京科卫临床诊断试剂有限公司 Beijing Kewei Clinical Diagnostic Reagent Inc In Review view
Y0404540 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 2004-07-05 上海科华生物工程股份有限公司 Shanghai Kehua Bio-Engineering Co Ltd Certificate Issued 2004-10-29 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
CYFB0900059 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 2010-06-13 北京万泰生物药业股份有限公司 Beijing Wantai Biological Pharmacy Enterprise Co Ltd Certificate Issued 2010-11-12 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
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
CYSS0900006 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 Generic Drug 2010-09-17 北京北方生物技术研究所 Beijing North Institute of BIOTECHNOLOGY Co Ltd Certificate Issued 2013-02-06 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
JXSS0800013 梅毒螺旋体抗体诊断试剂盒(酶联免疫检测法) Diagnostic reagent IVD Import Drug Application 2009-02-19 Murex Biotech Ltd. Murex Biotech Ltd Certificate Issued 2009-09-04 view
JYSB1100131 梅毒螺旋体抗体诊断试剂盒(酶联免疫检测法) Diagnostic reagent IVD Supplementary Application 2011-06-09 Murex Biotech Ltd. Murex Biotech Ltd Certificate Issued 2011-10-27 view
CYFB1000015 梅毒螺旋体抗体诊断试剂盒(酶联免疫法) Diagnostic reagent IVD Supplementary Application 2010-11-19 北京华大吉比爱生物技术有限公司 Beijing BGI-GBI Biotech Co Ltd In Review view
JYSB1200250 梅毒螺旋体抗体诊断试剂盒(酶联免疫法) Diagnostic reagent IVD Supplementary Application 2012-10-30 DiaSorin S.p.A.-UK Branch DiaSorin SpA UK Branch Certificate Issued 2013-05-03 view
CYSB2200291 梅毒螺旋体抗体诊断试剂盒(酶联免疫法) Diagnostic reagent IVD Supplementary Application 2022-12-30 Zhuhai Livzon Diagnostics INC view
CYFB1000083 梅毒螺旋体抗体诊断试剂盒(酶联免疫法) Diagnostic reagent IVD Supplementary Application 2011-03-03 北京万泰生物药业股份有限公司 Beijing Wantai Biological Pharmacy Enterprise Co Ltd Certificate Issued 2011-06-10 view
CYFB1000007 梅毒螺旋体抗体诊断试剂盒(酶联免疫法) Diagnostic reagent IVD Supplementary Application 2010-06-13 北京现代高达生物技术有限责任公司 Beijing Modern Gaoda Biotechnology Co Ltd Certificate Issued 2010-11-12 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
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
CYSB2200186 梅毒螺旋体抗体诊断试剂盒(酶联免疫法) Diagnostic reagent IVD Supplementary Application 2022-08-01 Shanghai Kehua Bio-Engineering Co Ltd view