| CSS01052 | 人补体因子C3免疫比浊法测定试剂盒 | | Diagnostic reagent | IVD(2) | New Drug Application | 2001-11-19 | 上海科华生物工程股份有限公司 | Shanghai Kehua Bio-Engineering Co Ltd | Certificate Issued | 2003-05-16 | view |
| CSS01053 | 人补体因子C4免疫比浊法测定试剂盒 | | Diagnostic reagent | IVD(2) | New Drug Application | 2001-11-19 | 上海科华生物工程股份有限公司 | Shanghai Kehua Bio-Engineering Co Ltd | Certificate Issued | 2003-05-16 | view |
| CSS01054 | 人免疫球蛋白IgA免疫比浊法测定试剂盒 | | Diagnostic reagent | IVD(2) | New Drug Application | 2001-11-19 | 上海科华生物工程股份有限公司 | Shanghai Kehua Bio-Engineering Co Ltd | Certificate Issued | 2003-06-15 | view |
| CSS01055 | 人免疫球蛋白IgG免疫比浊法测定试剂盒 | | Diagnostic reagent | IVD(2) | New Drug Application | 2001-11-19 | 上海科华生物工程股份有限公司 | Shanghai Kehua Bio-Engineering Co Ltd | Certificate Issued | 2003-05-30 | view |
| CSS01056 | 人免疫球蛋白IgM免疫比浊法测定试剂盒 | | Diagnostic reagent | IVD(2) | New Drug Application | 2001-11-19 | 上海科华生物工程股份有限公司 | Shanghai Kehua Bio-Engineering Co Ltd | Certificate Issued | 2003-08-25 | view |
| CSS01057 | 实时荧光PCR定量检测乙肝病毒试剂盒 | | Diagnostic reagent | IVD(2) | New Drug Application | 2001-12-06 | 上海科华生物工程股份有限公司 | Shanghai Kehua Bio-Engineering Co Ltd | Certificate Issued | 2003-06-11 | view |
| CSS20020045 | 人类免疫缺陷病毒抗体诊断试剂盒（金标法） | | Diagnostic reagent | IVD(2) | New Drug Application | 2002-08-16 | 上海科华生物工程股份有限公司 | Shanghai Kehua Bio-Engineering Co Ltd | Approval Completed-Pending Certificated | 2003-03-31 | view |
| CXSB0500027 | 乙型肝炎病毒（HBV）核酸扩增（PCR）荧光定量检测试剂盒 | | Diagnostic reagent | IVD | Supplementary Application | 2005-04-21 | 上海科华生物工程股份有限公司 | Shanghai Kehua Bio-Engineering Co Ltd | Certificate Issued | 2006-09-06 | view |
| CXSB0700056 | 人类免疫缺陷病毒（HIV1/2)抗体诊断试剂盒（胶体金法） | | Diagnostic reagent | IVD | Supplementary Application | 2008-04-07 | 上海科华生物工程股份有限公司 | Shanghai Kehua Bio-Engineering Co Ltd | Certificate Issued | 2017-01-23 | view |
| CXSS0700069 | HBV/HCV/HIV核酸检测试剂盒（PCR-荧光法） | | Diagnostic reagent | IVD | New Drug Application | 2007-12-27 | 上海科华生物工程股份有限公司 | Shanghai Kehua Bio-Engineering Co Ltd | Certificate Issued | 2010-11-23 | view |
| CXSS2000048 | 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 | 2020-09-12 | 上海科华生物工程股份有限公司 | Shanghai Kehua Bio-Engineering Co Ltd | In Review | 2020-09-11 | view |
| CXSS2100033 | 丙型肝炎病毒抗体诊断试剂盒（酶联免疫法） | | Diagnostic reagent | IVD(2) | New Drug Application | 2021-03-31 | 上海科华生物工程股份有限公司 | Shanghai Kehua Bio-Engineering Co Ltd | In Review | 2021-03-30 | view |
| CYSB1000185 | 梅毒螺旋体抗体诊断试剂盒(酶联免疫法) | | Diagnostic reagent | IVD | Supplementary Application | 2010-07-26 | 上海科华生物工程股份有限公司 | Shanghai Kehua Bio-Engineering Co Ltd | Certificate Issued | 2010-11-12 | view |
| CYSB1000193 | 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 | 2010-07-26 | 上海科华生物工程股份有限公司 | Shanghai Kehua Bio-Engineering Co Ltd | Certificate Issued | 2010-11-12 | view |
| CYSB1000194 | 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 | 2010-07-26 | 上海科华生物工程股份有限公司 | Shanghai Kehua Bio-Engineering Co Ltd | Certificate Issued | 2010-11-12 | view |
| CYSB1000195 | 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 | 2010-07-26 | 上海科华生物工程股份有限公司 | Shanghai Kehua Bio-Engineering Co Ltd | Certificate Issued | 2010-11-12 | view |
| CYSB1000196 | 丙型肝炎病毒抗体诊断试剂盒(酶联免疫法) | | Diagnostic reagent | IVD | Supplementary Application | 2010-07-26 | 上海科华生物工程股份有限公司 | Shanghai Kehua Bio-Engineering Co Ltd | Certificate Issued | 2010-11-12 | view |
| CYSB1000197 | 丙型肝炎病毒抗体诊断试剂盒(酶联免疫法) | | Diagnostic reagent | IVD | Supplementary Application | 2010-07-26 | 上海科华生物工程股份有限公司 | Shanghai Kehua Bio-Engineering Co Ltd | Certificate Issued | 2010-11-12 | view |
| CYSB1800175 | 梅毒快速血浆反应素诊断试剂 | | Diagnostic reagent | IVD | Supplementary Application | 2018-09-05 | 上海科华生物工程股份有限公司 | Shanghai Kehua Bio-Engineering Co Ltd | Certificate Issued | 2019-01-03 | view |
| CYSB1800279 | 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 | 2018-12-25 | 上海科华生物工程股份有限公司 | Shanghai Kehua Bio-Engineering Co Ltd | Certificate Issued | 2019-09-11 | view |
