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Acceptance No. Drug Name Active Ingredient Dosage Form Classification Submission Acceptance Date Manufacturers Manufacturers Review Status Status Date 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
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
JYSZ1800056 梅毒螺旋体抗体诊断试剂盒(酶联免疫法) Diagnostic reagent IVD License Renew 2018-11-14 DiaSorin SpA UK Branch Certificate Issued 2019-08-16 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
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
JYSB2000566 梅毒螺旋体抗体诊断试剂盒(酶联免疫法) Diagnostic reagent IVD Supplementary Application 2020-11-14 DiaSorin SpA UK Branch Filed 2020-11-24 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
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
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
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
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
CYSB1900265 梅毒螺旋体抗体诊断试剂盒(酶联免疫法) Diagnostic reagent IVD Supplementary Application 2019-07-18 上海科华生物工程股份有限公司 Shanghai Kehua Bio-Engineering Co Ltd Certificate Issued 2019-08-23 view
CYSB1000185 梅毒螺旋体抗体诊断试剂盒(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
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
CYSB1100486 梅毒螺旋体抗体诊断试剂盒(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 2012-05-28 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
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
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
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