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Acceptance No. Drug Name Active Ingredient Dosage Form Classification Submission Acceptance Date Manufacturers Manufacturers Review Status Status Date View
CYSB1800086 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 2018-05-10 英科新创(厦门)科技有限公司 InTec Products INC Certificate Issued 2018-07-06 view
CXFB1700001 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 2017-10-16 英科新创(厦门)科技有限公司 InTec Products INC Certificate Issued 2018-02-08 view
CYSS1000001 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 Generic Drug 2011-01-17 英科新创(厦门)科技有限公司 InTec Products INC Certificate Issued 2012-11-06 view
CXSS1000028 ABO血型定型试剂盒(固相法) Diagnostic reagent IVD New Drug Application 2011-01-06 英科新创(厦门)科技有限公司 InTec Products INC Certificate Issued 2012-10-30 view
CYSB1000035 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 2010-03-12 英科新创(厦门)科技有限公司 InTec Products INC Certificate Issued 2010-11-12 view
CYSB1000038 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 2010-03-12 英科新创(厦门)科技有限公司 InTec Products INC Certificate Issued 2010-07-21 view
CYSB1000036 丙型肝炎病毒抗体诊断试剂盒(酶联免疫法) Diagnostic reagent IVD Supplementary Application 2010-03-12 英科新创(厦门)科技有限公司 InTec Products INC Certificate Issued 2010-07-05 view
CYSB1000037 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 2010-03-12 英科新创(厦门)科技有限公司 InTec Products INC Certificate Issued 2010-07-05 view
CYSB0600105 人类免疫缺陷病毒抗体诊断试剂盒(胶体金法) Diagnostic reagent IVD Supplementary Application 2007-03-02 英科新创(厦门)科技有限公司 InTec Products INC In Approval 2010-01-27 view
CYSB0600127 乙型肝炎病毒表面抗原全血诊断试剂盒(胶体金法) Diagnostic reagent IVD Supplementary Application 2007-01-22 英科新创(厦门)科技有限公司 InTec Products INC Certificate Issued 2008-10-29 view
CYSS0600091 吗啡检测试剂(胶体金法) Diagnostic reagent IVD Generic Drug 2006-12-14 英科新创(厦门)科技有限公司 InTec Products INC In Approval 2008-07-29 view
CYSB0600130 乙肝五项检测卡(胶体金法) Diagnostic reagent IVD Supplementary Application 2007-01-22 英科新创(厦门)科技有限公司 InTec Products INC Certificate Issued 2008-07-21 view
CXSS0500079 人类免疫缺陷病毒HIV -1型抗体尿液检测试剂(胶体金法) Diagnostic reagent IVD New Drug Application 2005-08-03 英科新创(厦门)科技有限公司 InTec Products INC Certificate Issued 2007-08-02 view
CXSS0500073 乙型肝炎病毒表面抗体诊断试剂(胶体金法) Diagnostic reagent IVD New Drug Application 2005-08-03 英科新创(厦门)科技有限公司 InTec Products INC Certificate Issued 2006-12-05 view
CXSS0500075 乙型肝炎病毒e抗体诊断试剂(胶体金法) Diagnostic reagent IVD New Drug Application 2005-08-03 英科新创(厦门)科技有限公司 InTec Products INC Certificate Issued 2006-12-05 view
CXSS0500074 乙型肝炎病毒e抗原诊断试剂(胶体金法) Diagnostic reagent IVD New Drug Application 2005-08-03 英科新创(厦门)科技有限公司 InTec Products INC Certificate Issued 2006-12-05 view
CXSS0500076 乙型肝炎病毒核心抗体诊断试剂(胶体金法) Diagnostic reagent IVD New Drug Application 2005-08-03 英科新创(厦门)科技有限公司 InTec Products INC Certificate Issued 2006-07-14 view
X0401426 乙肝病毒DNA均相荧光PCR定量检测试剂盒 Diagnostic reagent IVD New Drug Application 2004-12-23 英科新创(厦门)科技有限公司 InTec Products INC Certificate Issued 2005-12-29 view
Y0403898 乙型肝炎病毒e抗体诊断试剂盒(酶联免疫法) Diagnostic reagent IVD Generic Drug 2005-01-04 英科新创(厦门)科技有限公司 InTec Products INC Certificate Issued 2005-12-27 view
X0407431 乙型肝炎病毒核心抗原IgM抗体诊断试剂盒(酶联免疫法) Diagnostic reagent IVD New Drug Application 2004-12-09 英科新创(厦门)科技有限公司 InTec Products INC Certificate Issued 2005-09-20 view