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Acceptance No. Drug Name Active Ingredient Dosage Form Classification Submission Acceptance Date Manufacturers Manufacturers Review Status Status Date View
CSS01018 人类免疫缺陷病毒抗体诊断试剂盒(胶体金法) Diagnostic reagent IVD(4) New Drug Application 2001-05-14 北京金豪制药有限公司 Beijing Kinghawk Pharmaceutical Co Ltd Certificate Issued 2003-03-20 view
CSS01021 人类免疫缺陷病毒抗体诊断试剂盒(胶体金法) Diagnostic reagent IVD(2) New Drug Application 2001-06-15 泉州长立生化有限公司厦门大学细胞生物学与肿瘤细胞工程教育部重点实验室 Certificate Issued 2003-08-25 view
CSS01039 人类免疫缺陷病毒抗体诊断试剂盒(金标法) Diagnostic reagent IVD(2) New Drug Application 2001-09-26 北京金伟凯医学生物技术有限公司 Goldenweikai MEDICAL BIOTECHNOLOGY Co Ltd Certificate Issued 2003-05-30 view
CSS20020034 人类免疫缺陷病毒抗体诊断试剂盒(金标法) Diagnostic reagent IVD(4) New Drug Application 2002-07-15 广州万孚生物技术有限公司 Guangzhou Wondfo BIOTECH Co Ltd Certificate Issued 2003-03-05 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
CSS20020046 人类免疫缺陷病毒抗体诊断试剂盒(胶体金法) Diagnostic reagent IVD(3) New Drug Application 2002-08-16 郑州绿科生物工程有限公司 Certificate Issued 2003-09-05 view
CSS20020045 人类免疫缺陷病毒抗体诊断试剂盒(金标法) Diagnostic reagent IVD(2) New Drug Application 2002-08-16 上海科华生物工程股份有限公司 Shanghai Kehua Bio-Engineering Co Ltd Approval Completed-Pending Certificated 2003-03-31 view
CSS20020047 人类免疫缺陷病毒抗体诊断试剂盒(胶体金法) Diagnostic reagent IVD(4) New Drug Application 2002-09-02 广州杰特免疫诊断制药有限公司 Guangzhou Jiete Immunodiagnostic Pharmaceutical Co Ltd Certificate Issued 2004-02-03 view
X0301141 人类免疫缺陷病毒抗体诊断试剂盒(金标法) Diagnostic reagent IVD New Drug Application 2003-08-15 郑州博赛生物技术研究所 Certificate Issued 2008-08-22 view
X0403530 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 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 2004-08-10 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
CYSS0600075 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 Generic Drug 2006-09-25 北京贝尔生物工程有限公司 Beijing Beier Bioengineering Co Ltd Certificate Issued 2008-07-21 view
CYSB0600105 人类免疫缺陷病毒抗体诊断试剂盒(胶体金法) Diagnostic reagent IVD Supplementary Application 2007-03-02 英科新创(厦门)科技有限公司 InTec Products INC In Approval 2010-01-27 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
CYSB0800173 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 Biological Products Supplementary Application 2008-12-12 郑州安图绿科生物工程有限公司 Autobio Diagnostics Co Ltd Certificate Issued 2009-04-08 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
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
CYSB1000182 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 2010-07-06 上海永华细胞和基因高技术有限公司 Shanghai Yonghua Cell & Gene High Technology Co Ltd 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
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