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Acceptance No. Drug Name Active Ingredient Dosage Form Classification Submission Acceptance Date Manufacturers Manufacturers Review Status Status Date View
X0306828 轮状病毒诊断试剂盒(胶体金法) Diagnostic reagent IVD New Drug Application 2004-12-07 北京万泰生物药业有限公司 Beijing Wantai Biological Pharmacy Enterprise Co Ltd Certificate Issued 2005-04-11 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
X0305577 SARS-CoV 抗体酶联免疫诊断试剂盒(双抗原夹心法) Diagnostic reagent IVD New Drug Application 2003-11-05 北京万泰生物药业有限公司 Beijing Wantai Biological Pharmacy Enterprise Co Ltd Certificate Issued 2005-11-07 view
X0304380 重组(大肠杆菌)戊型肝炎疫苗 Hepatitis E Vaccine(E.coli) Injection Biological Products(1) New Drug Application 2004-09-17 北京万泰生物药业有限公司 Beijing Wantai Biological Pharmacy Enterprise Co Ltd Certificate Issued 2004-12-06 view
X0303198 SARS-CoV IgM抗体酶联免疫诊断试剂盒(捕获法) Diagnostic reagent IVD New Drug Application 2003-07-07 北京万泰生物药业有限公司 Beijing Wantai Biological Pharmacy Enterprise Co Ltd Certificate Issued 2005-09-16 view
X0302344 戊型肝炎病毒IgM抗体酶联免疫诊断试剂盒(捕获法) Diagnostic reagent IVD New Drug Application 2003-12-24 北京万泰生物药业有限公司 Beijing Wantai Biological Pharmacy Enterprise Co Ltd Certificate Issued 2004-07-19 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
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
CYSS0700009 甲胎蛋白诊断试剂盒(酶联免疫法) Diagnostic reagent IVD Generic Drug 2007-06-27 北京万泰生物药业有限公司 Beijing Wantai Biological Pharmacy Enterprise Co Ltd Approval Completed-Pending Certificated view
CYSL0700002 冻干水痘减毒活疫苗 Lyophilized Biological Products(15) Generic Drug 2008-01-22 北京万泰生物药业有限公司 Beijing Wantai Biological Pharmacy Enterprise Co Ltd Certificate Issued 2008-12-22 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
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
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
CYSB1100174 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 2011-06-07 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
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
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
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
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
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