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Acceptance No. Drug Name Active Ingredient Dosage Form Classification Submission Acceptance Date Manufacturers Manufacturers Review Status Status Date View
CXSS0500093 乙型肝炎病毒核心IgM抗体诊断试剂盒(酶联免疫法) Diagnostic reagent IVD New Drug Application 2005-06-19 北京万泰生物药业有限公司 Beijing Wantai Biological Pharmacy Enterprise Co Ltd Certificate Completed-Pending Issued 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
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
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
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
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
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
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
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
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
CXSB0600048 重组(大肠杆菌)戊型肝炎疫苗 Hepatitis E Vaccine(E.coli) Injection Biological Products Supplementary Application 2006-07-18 北京万泰生物药业有限公司 Beijing Wantai Biological Pharmacy Enterprise Co Ltd Certificate Issued 2007-07-11 view
CXSS0600075 人类免疫缺陷病毒抗原抗体(HIV-Ag/Ab)诊断试剂盒(酶联免疫法) Diagnostic reagent IVD New Drug Application 2006-09-18 北京万泰生物药业有限公司 Beijing Wantai Biological Pharmacy Enterprise Co Ltd Certificate Issued 2008-04-30 view
CXSS0600074 戊型肝炎病毒抗原(HEV-Ag)诊断试剂盒(酶联免疫法) Diagnostic reagent IVD New Drug Application 2006-09-18 北京万泰生物药业有限公司 Beijing Wantai Biological Pharmacy Enterprise Co Ltd In Approval 2008-10-29 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
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
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
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
CYFB0900060 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 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
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