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Acceptance No. Drug Name Active Ingredient Dosage Form Classification Submission Acceptance Date Manufacturers Manufacturers Review Status Status Date View
CXSS0800001 血源筛查HBV、HCV、HIV-1病毒核酸检测试剂盒(PCR-荧光探针法) Diagnostic reagent Biological Products New Drug Application 2008-05-19 中山大学达安基因股份有限公司 Daan Gene Co Ltd Certificate Issued 2010-12-07 view
CXSS0800018 HBV/HCV/HIV-1核酸检测试剂盒(荧光PCR法) Diagnostic reagent Biological Products New Drug Application 2008-06-12 上海浩源生物科技有限公司 Shanghai Haoyuan Biotech Co Ltd Certificate Issued 2010-09-16 view
CYSB1500098 乙型肝炎病毒丙型肝炎病毒人类免疫缺陷病毒(1型)核酸检测试剂盒(PCR-荧光法) Diagnostic reagent IVD Supplementary Application 2015-08-24 上海浩源生物科技有限公司 Shanghai Haoyuan Biotech Co Ltd Certificate Issued 2016-04-18 view
CYFB1600009 乙型肝炎病毒丙型肝炎病毒人类免疫缺陷病毒(1型)核酸检测试剂盒(PCR-荧光法) Diagnostic reagent IVD Supplementary Application 2016-02-29 中山大学达安基因股份有限公司 Daan Gene Co Ltd Certificate Issued 2016-08-01 view
CXFB1700002 乙型肝炎病毒丙型肝炎病毒人类免疫缺陷病毒(1型)核酸检测试剂盒(PCR-荧光法) Diagnostic reagent IVD Supplementary Application 2017-11-28 中山大学达安基因股份有限公司 Daan Gene Co Ltd Certificate Issued 2018-02-23 view
CYSB1800104 乙型肝炎病毒、丙型肝炎病毒、人类免疫缺陷病毒(1型)核酸检测试剂盒(PCR-荧光法) Diagnostic reagent IVD Supplementary Application 2018-06-06 苏州新波生物技术有限公司 Suzhou SYM-BIO Life Science Co Ltd Certificate Issued 2019-09-30 view
CYSB1800103 乙型肝炎病毒丙型肝炎病毒人类免疫缺陷病毒(I型)核酸检测试剂盒(PCR-荧光法) Diagnostic reagent IVD Supplementary Application 2018-06-06 苏州新波生物技术有限公司 Suzhou SYM-BIO Life Science Co Ltd Certificate Issued 2020-03-26 view
CYSB1800147 乙型肝炎病毒丙型肝炎病毒人类免疫缺陷病毒(I型)核酸检测试剂盒(PCR-荧光法) Diagnostic reagent IVD Supplementary Application 2018-07-23 上海浩源生物科技有限公司 Shanghai Haoyuan Biotech Co Ltd Certificate Issued 2019-02-14 view
CYSB2000339 乙型肝炎病毒丙型肝炎病毒人类免疫缺陷病毒(1型)核酸检测试剂盒(PCR-荧光法) Diagnostic reagent IVD Supplementary Application 2020-12-14 中山大学达安基因股份有限公司 Daan Gene Co Ltd In Review 2020-12-11 view