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Acceptance No. Drug Name Active Ingredient Dosage Form Classification Submission Acceptance Date Manufacturers Manufacturers Review Status Status Date 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
CYSB2400289 梅毒螺旋体抗体诊断试剂盒(酶联免疫法) Diagnostic reagent IVD Supplementary Application 2024-11-05 InTec Products INC view
JYSZ2300020 梅毒螺旋体抗体诊断试剂盒(酶联免疫法) Diagnostic reagent IVD License Renew 2023-04-22 DiaSorin SpA;Diasorin Ltd 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
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
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
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
CXSS2101067 梅毒螺旋体抗体诊断试剂盒(磁微粒化学发光法) Diagnostic reagent IVD(2) New Drug Application 2021-12-22 Suzhou Bacme BIOTECH Co Ltd 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
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
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
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
CYSB0500134 梅毒螺旋体抗体诊断试剂盒(酶联免疫法) Diagnostic reagent IVD Supplementary Application 2005-09-01 上海荣盛生物技术有限公司 Shanghai Rongsheng Biological Pharmaceutical Co Ltd In Review 2005-08-30 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
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
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
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
JXSS0600032 梅毒螺旋体抗体诊断试剂盒(酶联免疫法) Diagnostic reagent IVD Import Drug Application 2006-09-13 Murex生物技术有限公司 Murex Biotech Ltd Certificate Issued 2008-07-21 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
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