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Acceptance No. Drug Name Active Ingredient Dosage Form Classification Submission Acceptance Date Manufacturers Manufacturers Review Status Status Date View
CSB00032 HIV 1+2型抗体试剂盒(双抗原夹心法) Diagnostic reagent IVD(2) Supplementary Application 2000-12-19 北京万泰生物药业有限公司 Beijing Wantai Biological Pharmacy Enterprise Co Ltd Certificate Issued 2008-12-26 view
X0302269 T淋巴细胞白血病病毒(HTLV)1+2抗体酶联免疫诊断试剂盒(双抗原夹心法) Diagnostic reagent IVD Supplementary Application 2004-01-10 北京万泰生物药业有限公司 Beijing Wantai Biological Pharmacy Enterprise Co Ltd Certificate Issued 2004-06-23 view
CXSS1100007 丙型肝炎病毒抗体诊断试剂盒(双抗原夹心酶联免疫法) Diagnostic reagent IVD New Drug Application 2011-11-08 北京万泰生物药业股份有限公司 Beijing Wantai Biological Pharmacy Enterprise Co Ltd Certificate Issued 2013-01-30 view
CYFB1000082 丙型肝炎病毒抗体诊断试剂盒(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
CYFB0900058 丙型肝炎病毒抗体诊断试剂盒(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
CYSS1400001 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-荧光探针法) Diagnostic reagent IVD Generic Drug 2015-05-09 北京万泰生物药业股份有限公司 Beijing Wantai Biological Pharmacy Enterprise Co Ltd Certificate Issued 2017-05-22 view
CXSS1200002 乙型肝炎病毒/丙型肝炎病毒/人类免疫缺陷病毒1型核酸联合检测试剂盒(PCR-荧光探针法) Diagnostic reagent IVD New Drug Application 2012-09-14 北京万泰生物药业股份有限公司 Beijing Wantai Biological Pharmacy Enterprise Co Ltd Certificate Issued 2015-04-22 view
CYSB2200015 乙型肝炎病毒、丙型肝炎病毒、人类免疫缺陷病毒(1+2型)核酸检测试剂盒(PCR-荧光法) Diagnostic reagent IVD Supplementary Application 2022-01-14 Beijing Wantai Biological Pharmacy Enterprise Co Ltd view
CYFB1800004 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 2018-08-06 北京万泰生物药业股份有限公司 Beijing Wantai Biological Pharmacy Enterprise Co Ltd Certificate Issued 2018-10-29 view
CYSB1500190 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 2015-10-13 北京万泰生物药业股份有限公司 Beijing Wantai Biological Pharmacy Enterprise Co Ltd Certificate Issued 2016-05-31 view
CYFB0900061 乙型肝炎病毒表面抗原诊断试剂盒(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 2011-05-11 view
CYFB0900056 乙型肝炎病毒表面抗原诊断试剂盒(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
CYFB1200002 乙型肝炎病毒表面抗原诊断试剂盒(酶联免疫法) Diagnostic reagent IVD Supplementary Application 2012-04-12 北京万泰生物药业股份有限公司 Beijing Wantai Biological Pharmacy Enterprise Co Ltd Certificate Issued 2012-08-21 view
CXSS0800008 乙型肝炎病毒表面抗原诊断试剂盒(酶联免疫法) Diagnostic reagent Biological Products New Drug Application 2008-06-26 北京万泰生物药业股份有限公司 Beijing Wantai Biological Pharmacy Enterprise Co Ltd Certificate Issued 2009-04-07 view
CYFB0900057 人类免疫缺陷病毒HIV(1+2型)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
X0306103 人类免疫缺陷病毒HIV(1+2型)抗体酶联免疫诊断试剂盒(双抗原夹心) Diagnostic reagent IVD Supplementary Application 2004-04-19 北京万泰生物药业有限公司 Beijing Wantai Biological Pharmacy Enterprise Co Ltd Certificate Issued 2005-02-04 view
CYSB1100173 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 2011-06-22 北京万泰生物药业股份有限公司 Beijing Wantai Biological Pharmacy Enterprise Co Ltd Certificate Issued 2011-10-20 view
CYSB1100052 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 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
CYSB1700121 人类免疫缺陷病毒抗原抗体诊断试剂盒(酶联免疫法) Diagnostic reagent IVD Supplementary Application 2017-11-16 北京万泰生物药业股份有限公司 Beijing Wantai Biological Pharmacy Enterprise Co Ltd Certificate Issued 2018-07-24 view
CYSB1100050 人类免疫缺陷病毒抗原抗体诊断试剂盒(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