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Acceptance No. Drug Name Active Ingredient Dosage Form Classification Submission Acceptance Date Manufacturers Manufacturers Review Status Status Date View
X0305498 癌胚抗原(CEA)化学发光免疫诊断试剂盒 Diagnostic reagent IVD New Drug Application 2005-01-28 华美生物工程公司 SINO-AMERICAN BIOTECHNOLOGY Co Ltd Certificate Issued 2005-08-25 view
X0305482 甲胎蛋白(AFP)化学发光免疫诊断试剂盒 Diagnostic reagent IVD New Drug Application 2004-08-12 华美生物工程公司 SINO-AMERICAN BIOTECHNOLOGY Co Ltd Certificate Issued 2005-01-21 view
X0302569 非典型肺炎冠状病毒核酸扩增(PCR)荧光检测试剂盒 Diagnostic reagent IVD New Drug Application 2004-04-28 华美生物工程公司 SINO-AMERICAN BIOTECHNOLOGY Co Ltd Certificate Issued 2004-09-24 view
X0301949 丙肝病毒核酸扩增(PCR)荧光定量检测试剂盒 Diagnostic reagent IVD New Drug Application 2004-02-02 华美生物工程公司 SINO-AMERICAN BIOTECHNOLOGY Co Ltd Certificate Issued 2004-08-10 view
CSS20020039 甲型肝炎病毒IgM抗体酶免诊断试剂盒 Diagnostic reagent IVD(2) New Drug Application 2004-01-12 华美生物工程公司河南省生物工程技术研究中心 Certificate Issued 2004-08-16 view
X0301943 促甲状腺素(TSH)化学发光免疫诊断试剂盒 Diagnostic reagent IVD New Drug Application 2003-12-24 华美生物工程公司 SINO-AMERICAN BIOTECHNOLOGY Co Ltd Certificate Issued 2004-06-11 view
X0303287 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 2003-08-29 华美生物工程公司 SINO-AMERICAN BIOTECHNOLOGY Co Ltd Certificate Issued 2004-03-01 view
X0303288 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 2003-08-29 华美生物工程公司 SINO-AMERICAN BIOTECHNOLOGY Co Ltd Certificate Issued 2004-03-01 view
CSb20020078 结核分支杆菌核酸扩增(PCR)酶免检测试剂盒 Diagnostic reagent IVD(2) Supplementary Application 2002-08-23 华美生物工程公司 SINO-AMERICAN BIOTECHNOLOGY Co Ltd Certificate Issued 2003-05-09 view
CSS20020016 乙肝病毒核酸扩增(PCR)荧光定量检测试剂盒 Diagnostic reagent IVD(2) New Drug Application 2002-03-26 华美生物工程公司河南省生物工程技术研究中心 Certificate Issued 2004-06-23 view
CSS01001 结核分支杆菌PCR分子灯塔荧光检测试剂盒 Diagnostic reagent IVD(4) New Drug Application 2001-04-02 华美生物工程公司 SINO-AMERICAN BIOTECHNOLOGY Co Ltd Certificate Issued 2001-11-28 view