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Acceptance No. Drug Name Active Ingredient Dosage Form Classification Submission Acceptance Date Manufacturers Manufacturers Review Status Status Date View
CXSS0600117 Ⅳ型胶原放射免疫分析药盒 Diagnostic reagent IVD New Drug Application 2006-11-01 北京北方生物技术研究所 Beijing North Institute of BIOTECHNOLOGY Co Ltd Certificate Issued 2009-01-19 view
CYSS0600100 碘[125I]糖类抗原19-9免疫放射分析药盒 Diagnostic reagent IVD Generic Drug 2007-01-10 北京北方生物技术研究所 Beijing North Institute of BIOTECHNOLOGY Co Ltd Certificate Issued 2008-08-07 view
CXSS0500145 前列腺特异抗原化学发光免疫诊断试剂盒 Diagnostic reagent IVD New Drug Application 2005-12-29 北京北方生物技术研究所 Beijing North Institute of BIOTECHNOLOGY Co Ltd Certificate Issued 2007-04-20 view
CYSS0600003 糖类抗原50免疫放射分析药盒 Diagnostic reagent IVD Generic Drug 2006-02-22 北京北方生物技术研究所 Beijing North Institute of BIOTECHNOLOGY Co Ltd Certificate Issued 2008-03-07 view
CYSS0600104 碘[125I]雌二醇放射免疫分析药盒 Diagnostic reagent IVD Generic Drug 2007-01-10 北京北方生物技术研究所 Beijing North Institute of BIOTECHNOLOGY Co Ltd Certificate Issued 2008-08-07 view
CYSS0500054 甲胎蛋白诊断试剂盒(酶联免疫法) Diagnostic reagent IVD Generic Drug 2005-07-25 北京北方生物技术研究所 Beijing North Institute of BIOTECHNOLOGY Co Ltd Certificate Issued 2006-04-10 view
CYSR1200001 丙型肝炎病毒抗体诊断试剂盒(酶联免疫法) Diagnostic reagent IVD State Standards 2012-01-31 北京北方生物技术研究所 Beijing North Institute of BIOTECHNOLOGY Co Ltd Certificate Issued 2013-01-30 view
CXSS0600004 层粘连蛋白放射免疫分析药盒 Diagnostic reagent IVD New Drug Application 2006-02-22 北京北方生物技术研究所 Beijing North Institute of BIOTECHNOLOGY Co Ltd Certificate Issued 2008-03-07 view
CYSS0600102 碘[125I]糖类抗原242免疫放射分析药盒 Diagnostic reagent IVD Generic Drug 2007-01-10 北京北方生物技术研究所 Beijing North Institute of BIOTECHNOLOGY Co Ltd Certificate Issued 2009-01-19 view
CXSS0500144 甲胎蛋白化学发光免疫诊断试剂盒 Diagnostic reagent IVD New Drug Application 2005-12-23 北京北方生物技术研究所 Beijing North Institute of BIOTECHNOLOGY Co Ltd Certificate Issued 2007-04-20 view
CYSS0600002 前列腺特异抗原免疫放射分析药盒 Diagnostic reagent IVD Generic Drug 2006-02-22 北京北方生物技术研究所 Beijing North Institute of BIOTECHNOLOGY Co Ltd Certificate Issued 2008-03-07 view
CYSS0600103 碘[125I]甲状腺过氧化酶自身抗体分析药盒 Diagnostic reagent IVD Generic Drug 2007-01-10 北京北方生物技术研究所 Beijing North Institute of BIOTECHNOLOGY Co Ltd Certificate Issued 2009-01-16 view
CYFB1000044 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 2010-12-03 北京北方生物技术研究所 Beijing North Institute of BIOTECHNOLOGY Co Ltd Certificate Issued 2011-03-25 view
CYSS0500135 内皮素放射免疫分析药盒 Diagnostic reagent IVD Generic Drug 2006-02-22 北京北方生物技术研究所 Beijing North Institute of BIOTECHNOLOGY Co Ltd Certificate Issued 2008-03-07 view
CXSS0600090 乙型肝炎病毒表面抗体时间分辨荧光免疫分析定量试剂盒 Diagnostic reagent IVD New Drug Application 2006-10-10 北京北方生物技术研究所 Beijing North Institute of BIOTECHNOLOGY Co Ltd In Approval 2008-08-05 view
CYSS0600001 透明质酸放射免疫分析药盒 Diagnostic reagent IVD Generic Drug 2006-02-22 北京北方生物技术研究所 Beijing North Institute of BIOTECHNOLOGY Co Ltd Certificate Issued 2008-03-07 view
CYSS0600101 碘[125I]糖类抗原153免疫放射分析药盒 Diagnostic reagent IVD Generic Drug 2007-01-10 北京北方生物技术研究所 Beijing North Institute of BIOTECHNOLOGY Co Ltd Certificate Issued 2009-01-19 view
CYSS0900006 梅毒螺旋体抗体诊断试剂盒(酶联免疫双抗原夹心法) Diagnostic reagent IVD Generic Drug 2010-09-17 北京北方生物技术研究所 Beijing North Institute of BIOTECHNOLOGY Co Ltd Certificate Issued 2013-02-06 view
CXSS0500172 Ⅲ型前胶原氨端肽(PⅢNP)放射免疫分析药盒 Diagnostic reagent IVD New Drug Application 2006-02-22 北京北方生物技术研究所 Beijing North Institute of BIOTECHNOLOGY Co Ltd Certificate Issued 2008-11-28 view
CYSS0600006 乙型肝炎病毒表面抗体诊断试剂盒(酶联免疫法) Diagnostic reagent IVD Generic Drug 2006-03-02 北京北方生物技术研究所 Beijing North Institute of BIOTECHNOLOGY Co Ltd Certificate Completed-Pending Issued view