| CSS20020035 | 人类免疫缺陷病毒抗体诊断试剂盒 | | Diagnostic reagent | IVD(4) | New Drug Application | 2002-08-01 | 中山生物工程有限公司 | Zhongshan BIO-TECH Co Ltd | Certificate Issued | 2003-06-20 | view |
| X0404311 | 聚凝胺一步法（OSPT）配血试剂盒 | | Diagnostic reagent | IVD | New Drug Application | 2004-08-01 | 中山生物工程有限公司 | Zhongshan BIO-TECH Co Ltd | Certificate Issued | 2006-12-05 | view |
| X0404317 | 聚凝胺三步法(TSPT)配血试剂盒 | | Diagnostic reagent | IVD | New Drug Application | 2004-08-05 | 中山生物工程有限公司 | Zhongshan BIO-TECH Co Ltd | Certificate Issued | 2006-12-05 | view |
| X0400720 | 乙型肝炎病毒(HBV)快速基因定量试剂盒 | | Diagnostic reagent | IVD | New Drug Application | 2004-10-08 | 中山生物工程有限公司 | Zhongshan BIO-TECH Co Ltd | Pending Approval | 2005-05-07 | view |
| X0407269 | EB病毒IgA抗体酶联免疫吸附法诊断试剂盒 | | Diagnostic reagent | IVD | New Drug Application | 2004-12-02 | 中山生物工程有限公司 | Zhongshan BIO-TECH Co Ltd | Certificate Issued | 2005-10-08 | view |
| CXHS0500007 | 乙型肝炎病毒表面抗体定量检测试剂盒（时间分辨荧光免疫分析法） | | Diagnostic reagent | IVD | New Drug Application | 2005-02-22 | 中山生物工程有限公司 | Zhongshan BIO-TECH Co Ltd | Certificate Issued | 2005-12-15 | view |
| CXSS0500004 | 乙型肝炎病毒表面抗原定量检测试剂盒（时间分辨荧光免疫分析法） | | Diagnostic reagent | IVD | New Drug Application | 2005-02-22 | 中山生物工程有限公司 | Zhongshan BIO-TECH Co Ltd | Certificate Issued | 2005-12-15 | view |
| CXSS0500056 | 登革病毒IgG 抗体酶联免疫诊断试剂盒 | | Diagnostic reagent | IVD | New Drug Application | 2005-07-01 | 中山生物工程有限公司 | Zhongshan BIO-TECH Co Ltd | Certificate Issued | 2007-01-11 | view |
| CXSS0500055 | 登革病毒IgM 抗体酶联免疫诊断试剂盒 | | Diagnostic reagent | IVD | New Drug Application | 2005-07-01 | 中山生物工程有限公司 | Zhongshan BIO-TECH Co Ltd | Certificate Issued | 2007-01-11 | view |
| CXSB0500169 | EB病毒IgA抗体酶联免疫吸附法诊断试剂盒 | | Diagnostic reagent | IVD | Supplementary Application | 2006-02-13 | 中山生物工程有限公司 | Zhongshan BIO-TECH Co Ltd | Certificate Completed-Pending Issued | | view |
| CYFB1100059 | 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 | 2011-05-16 | 中山生物工程有限公司 | Zhongshan BIO-TECH Co Ltd | Certificate Issued | 2011-08-03 | view |
| CYFB1100058 | 梅毒螺旋体抗体酶联免疫诊断试剂盒(双抗原夹心法) | | Diagnostic reagent | IVD | Supplementary Application | 2011-05-16 | 中山生物工程有限公司 | Zhongshan BIO-TECH Co Ltd | Certificate Issued | 2011-10-20 | view |
| CYFB1100057 | 丙型肝炎病毒抗体诊断试剂盒(酶联免疫法) | | Diagnostic reagent | IVD | Supplementary Application | 2011-05-16 | 中山生物工程有限公司 | Zhongshan BIO-TECH Co Ltd | Certificate Issued | 2011-10-20 | view |
| CYFB1100060 | 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 | 2011-05-16 | 中山生物工程有限公司 | Zhongshan BIO-TECH Co Ltd | Certificate Issued | 2011-10-20 | view |
