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Acceptance No. Drug Name Active Ingredient Dosage Form Classification Submission Acceptance Date Manufacturers Manufacturers Review Status Status Date View
CXSB0600023 冠状病毒(变异株)IgG抗体检测试剂盒(间接免疫荧光法) Diagnostic reagent IVD Supplementary Application 2006-05-30 北京华大吉比爱生物技术有限公司 Beijing BGI-GBI Biotech Co Ltd Certificate Issued 2007-05-11 view
CXSB0600024 冠状病毒(变异株)IgM抗体检测试剂盒(间接免疫荧光法) Diagnostic reagent IVD Supplementary Application 2006-05-30 北京华大吉比爱生物技术有限公司 Beijing BGI-GBI Biotech Co Ltd Certificate Issued 2007-05-11 view
CXSS0500163 EB病毒壳抗原(VCA) IgA 抗体诊断试剂盒(酶联免疫法) Diagnostic reagent IVD New Drug Application 2006-01-05 北京华大吉比爱生物技术有限公司 Beijing BGI-GBI Biotech Co Ltd Certificate Completed-Pending Issued view
CXSS1100017 人类免疫缺陷病毒(HIV)抗原/抗体诊断试剂盒(酶联免疫法) Diagnostic reagent IVD New Drug Application 2012-03-01 北京华大吉比爱生物技术有限公司 Beijing BGI-GBI Biotech Co Ltd Certificate Issued 2014-04-09 view
CYFB1000013 人类免疫缺陷病毒抗体诊断试剂盒(酶联免疫法) Diagnostic reagent IVD Supplementary Application 2010-10-26 北京华大吉比爱生物技术有限公司 Beijing BGI-GBI Biotech Co Ltd In Review view
CYFB1000014 丙型肝炎病毒抗体诊断试剂盒(酶联免疫法) Diagnostic reagent IVD Supplementary Application 2010-10-26 北京华大吉比爱生物技术有限公司 Beijing BGI-GBI Biotech Co Ltd In Review view
CYFB1000015 梅毒螺旋体抗体诊断试剂盒(酶联免疫法) Diagnostic reagent IVD Supplementary Application 2010-11-19 北京华大吉比爱生物技术有限公司 Beijing BGI-GBI Biotech Co Ltd In Review view
CYFB1000016 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 2010-10-26 北京华大吉比爱生物技术有限公司 Beijing BGI-GBI Biotech Co Ltd In Review view
CYSB2000160 人类免疫缺陷病毒(HIV)抗原抗体诊断试剂盒(酶联免疫法) Diagnostic reagent IVD Supplementary Application 2020-06-29 北京华大吉比爱生物技术有限公司 Beijing BGI-GBI Biotech Co Ltd Certificate Issued 2020-09-10 view
X0306112 冠状病毒(变异株)IgM抗体检测试剂盒(酶联免疫法) Diagnostic reagent IVD Supplementary Application 2004-04-23 北京华大吉比爱生物技术有限公司 Beijing BGI-GBI Biotech Co Ltd Certificate Issued 2004-11-01 view
X0306113 冠状病毒(变异株)IgG抗体检测试剂盒(酶联免疫法) Diagnostic reagent IVD Supplementary Application 2004-04-23 北京华大吉比爱生物技术有限公司 Beijing BGI-GBI Biotech Co Ltd Certificate Issued 2004-11-01 view
X0401659 冠状病毒(变异株)核酸扩增(RT-PCR)荧光检测试剂盒 Diagnostic reagent IVD New Drug Application 2004-09-13 北京华大吉比爱生物技术有限公司 Beijing BGI-GBI Biotech Co Ltd Certificate Issued 2006-08-29 view
X0401660 冠状病毒(变异株)抗体酶联免疫诊断试剂盒(双抗原夹心法) Diagnostic reagent IVD New Drug Application 2004-04-07 北京华大吉比爱生物技术有限公司 Beijing BGI-GBI Biotech Co Ltd Certificate Issued 2005-11-02 view