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Acceptance No. Drug Name Active Ingredient Dosage Form Classification Submission Acceptance Date Manufacturers Manufacturers Review Status Status Date View
CYSB0700016 酪酸梭菌、双歧杆菌二联活菌胶囊 bifidobacterium;clostridium butyricum Capsule Biological Products Supplementary Application 2007-03-02 北京源德生物医学工程有限公司 Beijing Yuande Bio-Medical Engineering Co Ltd;Kexing Biopharm Co Ltd In Review view
CXSS0600127 人类免疫缺陷病毒(HIV)1+2系列蛋白抗体测定试剂盒(化学发光法) Diagnostic reagent IVD New Drug Application 2007-01-10 北京源德生物医学工程有限公司 Beijing Yuande Bio-Medical Engineering Co Ltd;China Center For Disease Control and Prevention Certificate Issued 2008-12-22 view
CXSS0600122 人类免疫缺陷病毒(HIV)1+2型抗体测定试剂盒(化学发光法) Diagnostic reagent IVD New Drug Application 2007-01-10 北京源德生物医学工程有限公司 Beijing Yuande Bio-Medical Engineering Co Ltd Approval Completed-Pending Certificated view
CXSS0600031 游离前列腺特异性抗原(FPSA)定量测定试剂盒(化学发光法) Diagnostic reagent IVD New Drug Application 2006-03-07 北京源德生物医学工程有限公司 Beijing Yuande Bio-Medical Engineering Co Ltd Certificate Completed-Pending Issued view
CXSS0600030 糖类抗原50(CA50)定量测定试剂盒(化学发光法) Diagnostic reagent IVD New Drug Application 2006-03-07 北京源德生物医学工程有限公司 Beijing Yuande Bio-Medical Engineering Co Ltd Approval Completed-Pending Certificated 2008-04-08 view
CXSB0700060 新型冠状病毒(N-蛋白)测定试剂盒(化学发光法) Diagnostic reagent IVD Supplementary Application 2008-05-16 北京源德生物医学工程有限公司 Beijing Yuande Bio-Medical Engineering Co Ltd Certificate Issued 2010-02-26 view
CXSB0700059 人促甲状腺素(TSH)定量测定试剂盒(化学发光法) Diagnostic reagent IVD Supplementary Application 2008-05-16 北京源德生物医学工程有限公司 Beijing Yuande Bio-Medical Engineering Co Ltd Certificate Issued 2010-02-26 view
CXSB0700058 癌胚抗原(CEA)定量测定试剂盒(化学发光法) Diagnostic reagent IVD Supplementary Application 2008-05-16 北京源德生物医学工程有限公司 Beijing Yuande Bio-Medical Engineering Co Ltd Certificate Issued 2010-02-26 view
CXSB0700053 促卵泡生成激素(FSH)定量测定试剂盒(化学发光法) Diagnostic reagent IVD Supplementary Application 2008-05-16 北京源德生物医学工程有限公司 Beijing Yuande Bio-Medical Engineering Co Ltd Certificate Issued 2010-02-09 view
CXSB0700052 人绒毛膜促性腺激素(HCG)定量测定试剂盒(化学发光法) Diagnostic reagent IVD Supplementary Application 2008-05-16 北京源德生物医学工程有限公司 Beijing Yuande Bio-Medical Engineering Co Ltd Certificate Issued 2010-02-26 view
CXSB0700051 促黄体生成素(LH)定量测定试剂盒(化学发光法) Diagnostic reagent IVD Supplementary Application 2008-05-16 北京源德生物医学工程有限公司 Beijing Yuande Bio-Medical Engineering Co Ltd Certificate Issued 2010-02-26 view
CXSB0700050 甲胎蛋白(AFP)定量测定试剂盒(化学发光法) Diagnostic reagent IVD Supplementary Application 2008-05-16 北京源德生物医学工程有限公司 Beijing Yuande Bio-Medical Engineering Co Ltd Certificate Issued 2010-02-26 view
CXSB0700049 C-肽(C-P)定量测定试剂盒(化学发光法) Diagnostic reagent IVD Supplementary Application 2008-05-16 北京源德生物医学工程有限公司 Beijing Yuande Bio-Medical Engineering Co Ltd Certificate Issued 2010-02-26 view
CXSB0700048 胰岛素定量测定试剂盒(化学发光法) Diagnostic reagent IVD Supplementary Application 2008-05-16 北京源德生物医学工程有限公司 Beijing Yuande Bio-Medical Engineering Co Ltd Certificate Issued 2010-02-26 view
CXSB0700046 前列腺特异性抗原(PSA)定量测定试剂盒(化学发光法) Diagnostic reagent IVD Supplementary Application 2008-05-16 北京源德生物医学工程有限公司 Beijing Yuande Bio-Medical Engineering Co Ltd Certificate Issued 2010-03-04 view
CXSB0600086 前列腺特异性抗原(PSA)定量测定试剂盒(化学发光法) Diagnostic reagent IVD Supplementary Application 2006-08-20 北京源德生物医学工程有限公司 Beijing Yuande Bio-Medical Engineering Co Ltd Certificate Issued 2007-08-02 view