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Acceptance No. Drug Name Active Ingredient Dosage Form Classification Submission Acceptance Date Manufacturers Manufacturers Review Status Status Date View
CXSS2100033 丙型肝炎病毒抗体诊断试剂盒(酶联免疫法) Diagnostic reagent IVD(2) New Drug Application 2021-03-31 上海科华生物工程股份有限公司 Shanghai Kehua Bio-Engineering Co Ltd In Review 2021-03-30 view
JYSB2000556 丙型肝炎病毒抗体检测试剂盒(酶联免疫法) Diagnostic reagent IVD(2) Supplementary Application 2020-11-02 DiaSorin SpA UK Branch Filed 2020-11-16 view
JYSB2000381 丙型肝炎病毒抗体诊断试剂盒(酶联免疫法) Diagnostic reagent IVD Supplementary Application 2020-08-21 Ortho-Clinical Diagnostics Inc Filed 2020-09-01 view
JXSS1800031 丙型肝炎病毒抗体检测试剂盒(酶联免疫法) Diagnostic reagent IVD Import Drug Application 2018-12-03 DiaSorin SpA UK Branch Certificate Issued 2020-06-08 view
JYSZ1800060 丙型肝炎病毒抗体诊断试剂盒(酶联免疫法) Diagnostic reagent IVD License Renew 2018-12-10 奥森多医疗器械贸易(中国)有限公司 Ortho-Clinical Diagnostics Trading (China) Co Ltd Certificate Issued 2019-12-26 view
JTS1900053 丙型肝炎病毒抗体诊断试剂盒(酶联免疫法) Diagnostic reagent IVD Disposable Import Drug Application 2019-11-01 Ortho-Clinical Diagnostics, Inc. Ortho-Clinical Diagnostics Inc Certificate Issued 2019-11-15 view
JYSZ1900004 丙型肝炎病毒抗体诊断试剂盒(酶联免疫法) Diagnostic reagent IVD License Renew 2019-02-22 Diasorin South Africa (Proprietary) Ltd Certificate Issued 2019-10-22 view
JYSB1800216 丙型肝炎病毒抗体诊断试剂盒(酶联免疫法) Diagnostic reagent IVD Supplementary Application 2018-10-15 亚特斯公司 Adaltis Inc Filed 2018-10-31 view
CYFB1700010 丙型肝炎病毒抗体诊断试剂盒(酶联免疫法) Diagnostic reagent IVD Supplementary Application 2017-12-07 郑州安图生物工程股份有限公司 Autobio Diagnostics Co Ltd Certificate Issued 2018-03-12 view
JYSB1700054 丙型肝炎病毒抗体诊断试剂盒(酶联免疫法) Diagnostic reagent IVD Supplementary Application 2017-04-10 奥森多医疗器械贸易(中国)有限公司 Ortho-Clinical Diagnostics Trading (China) Co Ltd Certificate Issued 2017-07-17 view
CYSB1500109 丙型肝炎病毒抗体诊断试剂盒(酶联免疫法) Diagnostic reagent IVD Supplementary Application 2015-06-29 珠海丽珠试剂股份有限公司 Zhuhai Livzon Diagnostics INC Certificate Issued 2016-02-03 view
CYFB1400020 丙型肝炎病毒抗体诊断试剂盒(酶联免疫法) Diagnostic reagent IVD Supplementary Application 2015-01-04 湖南康润药业有限公司 Hunan Runkun Pharmaceutical Co Ltd Certificate Issued 2015-03-26 view
CXFS1400003 丙型肝炎病毒抗体诊断试剂盒(酶联免疫法) Diagnostic reagent IVD New Drug Application 2014-07-17 珠海丽珠试剂股份有限公司 Zhuhai Livzon Diagnostics INC Certificate Issued 2014-12-18 view
JYSB1200314 丙型肝炎病毒抗体诊断试剂盒(酶联免疫法) Diagnostic reagent IVD Supplementary Application 2013-01-08 DiaSorin South Africa(Pty) Ltd. Diasorin South Africa (Proprietary) Ltd Certificate Issued 2013-05-03 view
CYFB1200084 丙型肝炎病毒抗体诊断试剂盒(酶联免疫法) Diagnostic reagent IVD Supplementary Application 2013-01-06 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 2013-04-23 view
CYSR1200001 丙型肝炎病毒抗体诊断试剂盒(酶联免疫法) Diagnostic reagent IVD State Standards 2012-01-31 北京北方生物技术研究所 Beijing North Institute of BIOTECHNOLOGY Co Ltd Certificate Issued 2013-01-30 view
CYFB1200069 丙型肝炎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
CYSB1100491 丙型肝炎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
CYSB1200072 丙型肝炎病毒抗体诊断试剂盒(酶联免疫法) Diagnostic reagent IVD Supplementary Application 2012-03-09 上海中信亚特斯诊断试剂有限公司 Shanghai CP Adaltis Diagnostics Company Limited Certificate Issued 2012-08-21 view
JXSS1100003 丙型肝炎病毒抗体诊断试剂盒(酶联免疫法) Diagnostic reagent IVD Import Drug Application 2011-10-08 伯乐公司 Bio-Rad Laboratories Inc Certificate Issued 2012-02-20 view