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Acceptance No. Drug Name Active Ingredient Dosage Form Classification Submission Acceptance Date Manufacturers Manufacturers Review Status Status Date 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
CXSB0700082 人类免疫缺陷病毒抗体诊断试剂盒(化学发光法) Diagnostic reagent IVD Supplementary Application 2007-11-06 北京科美东雅生物技术有限公司 Beijing Chemclin Biotech Co Ltd In Review 2007-12-24 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
CYSB1000035 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 2010-03-12 英科新创(厦门)科技有限公司 InTec Products INC Certificate Issued 2010-11-12 view
CYSB1000180 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 2010-07-07 上海荣盛生物药业有限公司 Shanghai Rongsheng Biological Pharmaceutical Co Ltd Certificate Issued 2011-01-24 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
JYSB0500091 人类免疫缺陷病毒抗体诊断试剂盒(胶体金渗透法) Diagnostic reagent IVD Supplementary Application 2005-11-09 加拿大麦美华公司 Medmira Certificate Completed-Pending Issued 2006-03-03 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
CYFB1000033 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 2010-08-16 郑州安图绿科生物工程有限公司 Autobio Diagnostics Co Ltd Certificate Issued 2010-11-12 view
CYSB1000028 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 2010-06-30 上海梅里埃生物工程有限公司 Shanghai BioMerieux Bio-engineering Co Ltd Certificate Issued 2010-12-29 view
CYFB1000073 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 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 2011-04-27 view
CYSB1000195 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 2010-07-26 上海科华生物工程股份有限公司 Shanghai Kehua Bio-Engineering Co Ltd Certificate Issued 2010-11-12 view
CYSB1100052 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 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
CYSB1900337 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 2019-09-29 上海科华生物工程股份有限公司 Shanghai Kehua Bio-Engineering Co Ltd Certificate Issued 2019-12-06 view
CYFB1000013 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 2010-10-26 北京华大吉比爱生物技术有限公司 Beijing BGI-GBI Biotech Co Ltd In Review view
CYSB1200099 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 2012-03-27 上海荣盛生物药业有限公司 Shanghai Rongsheng Biological Pharmaceutical Co Ltd Certificate Issued 2012-08-21 view
CXFS1000007 人类免疫缺陷病毒抗体诊断试剂盒(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 2012-01-11 view
CYSB1800254 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 2018-11-20 郑州安图生物工程股份有限公司 Autobio Diagnostics Co Ltd Certificate Issued 2019-01-03 view
CYSB1000051 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 2010-10-26 北京贝尔生物工程有限公司 Beijing Beier Bioengineering Co Ltd In Review view
CYSB1100492 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 2011-11-14 兰州生物制品研究所有限责任公司 Lanzhou Institute of Biological Products Co Ltd Certificate Issued 2012-08-21 view