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Acceptance No. Drug Name Active Ingredient Dosage Form Classification Submission Acceptance Date Manufacturers Manufacturers Review Status Status Date View
CYSS0600073 戊型肝炎病毒IgM抗体诊断试剂盒(酶联免疫法) Diagnostic reagent IVD Generic Drug 2006-09-18 上海科华生物工程股份有限公司 Shanghai Kehua Bio-Engineering Co Ltd Certificate Completed-Pending Issued view
CSS20020045 人类免疫缺陷病毒抗体诊断试剂盒(金标法) Diagnostic reagent IVD(2) New Drug Application 2002-08-16 上海科华生物工程股份有限公司 Shanghai Kehua Bio-Engineering Co Ltd Approval Completed-Pending Certificated 2003-03-31 view
CSS01053 人补体因子C4免疫比浊法测定试剂盒 Diagnostic reagent IVD(2) New Drug Application 2001-11-19 上海科华生物工程股份有限公司 Shanghai Kehua Bio-Engineering Co Ltd Certificate Issued 2003-05-16 view
CSS01052 人补体因子C3免疫比浊法测定试剂盒 Diagnostic reagent IVD(2) New Drug Application 2001-11-19 上海科华生物工程股份有限公司 Shanghai Kehua Bio-Engineering Co Ltd Certificate Issued 2003-05-16 view
CSS01055 人免疫球蛋白IgG免疫比浊法测定试剂盒 Diagnostic reagent IVD(2) New Drug Application 2001-11-19 上海科华生物工程股份有限公司 Shanghai Kehua Bio-Engineering Co Ltd Certificate Issued 2003-05-30 view
CSS01057 实时荧光PCR定量检测乙肝病毒试剂盒 Diagnostic reagent IVD(2) New Drug Application 2001-12-06 上海科华生物工程股份有限公司 Shanghai Kehua Bio-Engineering Co Ltd Certificate Issued 2003-06-11 view
CSS01054 人免疫球蛋白IgA免疫比浊法测定试剂盒 Diagnostic reagent IVD(2) New Drug Application 2001-11-19 上海科华生物工程股份有限公司 Shanghai Kehua Bio-Engineering Co Ltd Certificate Issued 2003-06-15 view
CSS01056 人免疫球蛋白IgM免疫比浊法测定试剂盒 Diagnostic reagent IVD(2) New Drug Application 2001-11-19 上海科华生物工程股份有限公司 Shanghai Kehua Bio-Engineering Co Ltd Certificate Issued 2003-08-25 view
X0302486 非典型性肺炎(SARS)病原体核酸扩增(PCR)-荧光检测试剂盒 Diagnostic reagent IVD New Drug Application 2003-10-20 上海科华生物工程股份有限公司 Shanghai Kehua Bio-Engineering Co Ltd Certificate Issued 2004-01-19 view
X0403530 人类免疫缺陷病毒抗体诊断试剂盒(双抗原夹心酶联免疫法) Diagnostic reagent IVD Supplementary Application 2004-07-05 上海科华生物工程股份有限公司 Shanghai Kehua Bio-Engineering Co Ltd Certificate Issued 2004-08-10 view
X0301982 丙型肝炎病毒核酸扩增(PCR)-荧光定量检测试剂盒 Diagnostic reagent IVD New Drug Application 2004-04-20 上海科华生物工程股份有限公司 Shanghai Kehua Bio-Engineering Co Ltd Certificate Issued 2004-09-24 view
Y0404540 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 2004-07-05 上海科华生物工程股份有限公司 Shanghai Kehua Bio-Engineering Co Ltd Certificate Issued 2004-10-29 view
X0301971 乙型肝炎病毒表面抗原胶体金法诊断试剂盒 Diagnostic reagent IVD New Drug Application 2004-03-17 上海科华生物工程股份有限公司 Shanghai Kehua Bio-Engineering Co Ltd Certificate Issued 2004-10-29 view
X0400556 乙型肝炎病毒核心抗体IgM诊断试剂盒(酶联免疫法) Diagnostic reagent IVD New Drug Application 2004-08-27 上海科华生物工程股份有限公司 Shanghai Kehua Bio-Engineering Co Ltd Certificate Issued 2005-01-31 view
X0305597 HIV核酸扩增(PCR)-荧光检测试剂盒 Diagnostic reagent IVD New Drug Application 2004-07-14 上海科华生物工程股份有限公司 Shanghai Kehua Bio-Engineering Co Ltd Pending Approval 2005-05-11 view
Y0411150 甲胎蛋白诊断试剂盒(酶联免疫法) Diagnostic reagent IVD Generic Drug 2004-09-30 上海科华生物工程股份有限公司 Shanghai Kehua Bio-Engineering Co Ltd Certificate Issued 2005-08-19 view
X0407883 人类T淋巴细胞白血病病毒(HTLV)1+2型抗体诊断试剂盒(酶联免疫法) Diagnostic reagent IVD Supplementary Application 2004-12-22 上海科华生物工程股份有限公司 Shanghai Kehua Bio-Engineering Co Ltd Certificate Issued 2006-04-28 view
X0404715 新型冠状病毒核酸扩增(PCR)-荧光检测试剂盒 Diagnostic reagent IVD Supplementary Application 2004-08-23 上海科华生物工程股份有限公司 Shanghai Kehua Bio-Engineering Co Ltd In Approval 2006-07-20 view
CXSB0500027 乙型肝炎病毒(HBV)核酸扩增(PCR)荧光定量检测试剂盒 Diagnostic reagent IVD Supplementary Application 2005-04-21 上海科华生物工程股份有限公司 Shanghai Kehua Bio-Engineering Co Ltd Certificate Issued 2006-09-06 view
CYSB1000185 梅毒螺旋体抗体诊断试剂盒(酶联免疫法) Diagnostic reagent IVD Supplementary Application 2010-07-26 上海科华生物工程股份有限公司 Shanghai Kehua Bio-Engineering Co Ltd Certificate Issued 2010-11-12 view