| CXSS0700004 | 乙型肝炎病毒核心抗体定量测定试剂盒（时间分辨荧光免疫法） | | Diagnostic reagent | IVD | New Drug Application | 2007-03-09 | 苏州新波生物技术有限公司 | Suzhou SYM-BIO Life Science Co Ltd | Approval Completed-Pending Certificated | | view |
| CXSS0500078 | 乙型肝炎病毒表面抗原定量检测诊断试剂盒（时间分辨免疫荧光分析法） | | Diagnostic reagent | IVD | New Drug Application | 2005-09-01 | 苏州新波生物技术有限公司 | Suzhou SYM-BIO Life Science Co Ltd | Certificate Issued | 2006-12-05 | view |
| CXSS0500077 | 乙型肝炎病毒表面抗体定量检测诊断试剂盒（时间分辨免疫荧光分析法） | | Diagnostic reagent | IVD | New Drug Application | 2005-09-01 | 苏州新波生物技术有限公司 | Suzhou SYM-BIO Life Science Co Ltd | Certificate Issued | 2006-12-07 | view |
| CXSS0500099 | 癌胚抗原诊断试剂盒（时间分辨免疫荧光分析法） | | Diagnostic reagent | IVD | New Drug Application | 2005-09-01 | 苏州新波生物技术有限公司 | Suzhou SYM-BIO Life Science Co Ltd | Certificate Issued | 2007-01-11 | view |
| CXSS0500098 | 甲胎蛋白诊断试剂盒（时间分辨免疫荧光分析法） | | Diagnostic reagent | IVD | New Drug Application | 2005-09-01 | 苏州新波生物技术有限公司 | Suzhou SYM-BIO Life Science Co Ltd | In Approval | 2007-02-08 | view |
| CXSS0600120 | 丙型肝炎病毒抗体诊断试剂盒（双抗原夹心时间分辨免疫荧光分析法） | | Diagnostic reagent | IVD | New Drug Application | 2006-12-12 | 苏州新波生物技术有限公司 | Suzhou SYM-BIO Life Science Co Ltd | In Approval | 2008-11-27 | view |
| CXSS0700009 | 乙型肝炎病毒e抗原定量测定试剂盒（时间分辨免疫荧光法） | | Diagnostic reagent | IVD | New Drug Application | 2007-03-09 | 苏州新波生物技术有限公司 | Suzhou SYM-BIO Life Science Co Ltd | In Approval | 2008-11-27 | view |
| CXSS0600121 | 梅毒螺旋体抗体诊断试剂盒（双抗原夹心时间分辨免疫荧光分析法） | | Diagnostic reagent | IVD | New Drug Application | 2006-11-30 | 苏州新波生物技术有限公司 | Suzhou SYM-BIO Life Science Co Ltd | In Approval | 2008-11-27 | view |
| CXSS0700008 | 乙型肝炎病毒e抗体定量测定试剂盒（时间分辨荧光免疫法） | | Diagnostic reagent | IVD | New Drug Application | 2007-03-09 | 苏州新波生物技术有限公司 | Suzhou SYM-BIO Life Science Co Ltd | In Approval | 2008-11-27 | view |
| CXSS0700007 | CA19-9定量检测试剂盒（时间分辨免疫荧光法） | | Diagnostic reagent | IVD | New Drug Application | 2007-03-09 | 苏州新波生物技术有限公司 | Suzhou SYM-BIO Life Science Co Ltd | In Approval | 2008-11-27 | view |
| CXSS0700006 | 前列腺特异性抗原定量检测试剂盒（时间分辨免疫荧光法） | | Diagnostic reagent | IVD | New Drug Application | 2007-03-09 | 苏州新波生物技术有限公司 | Suzhou SYM-BIO Life Science Co Ltd | In Approval | 2008-11-27 | view |
| CXSS0700010 | 游离前列腺特异性抗原定量检测试剂盒（时间分辨免疫荧光法） | | Diagnostic reagent | IVD | New Drug Application | 2007-03-09 | 苏州新波生物技术有限公司 | Suzhou SYM-BIO Life Science Co Ltd | In Approval | 2008-11-27 | view |
| CXSS0700005 | CA125定量检测试剂盒（时间分辨免疫荧光法） | | Diagnostic reagent | IVD | New Drug Application | 2007-03-09 | 苏州新波生物技术有限公司 | Suzhou SYM-BIO Life Science Co Ltd | In Approval | 2008-11-27 | view |
| CXSS0700011 | 乙型肝炎病毒核心抗体IgM定量测定试剂盒（时间分辨免疫荧光法） | | Diagnostic reagent | IVD | New Drug Application | 2007-03-09 | 苏州新波生物技术有限公司 | Suzhou SYM-BIO Life Science Co Ltd | In Approval | 2008-11-27 | view |
| CYSB1800104 | 乙型肝炎病毒、丙型肝炎病毒、人类免疫缺陷病毒(1型)核酸检测试剂盒(PCR-荧光法) | | Diagnostic reagent | IVD | Supplementary Application | 2018-06-06 | 苏州新波生物技术有限公司 | Suzhou SYM-BIO Life Science Co Ltd | Certificate Issued | 2019-09-30 | view |
| CYSB1800103 | 乙型肝炎病毒丙型肝炎病毒人类免疫缺陷病毒(I型)核酸检测试剂盒(PCR-荧光法) | | Diagnostic reagent | IVD | Supplementary Application | 2018-06-06 | 苏州新波生物技术有限公司 | Suzhou SYM-BIO Life Science Co Ltd | Certificate Issued | 2020-03-26 | view |
| CXSS2100010 | 乙型肝炎病毒丙型肝炎病毒人类免疫缺陷病毒（1+2型）核酸检测试剂盒（PCR-荧光法） | | Diagnostic reagent | IVD(2) | New Drug Application | 2021-01-16 | 苏州新波生物技术有限公司 | Suzhou SYM-BIO Life Science Co Ltd | In Review | 2021-01-15 | view |
