| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
