| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| X0302486 | 非典型性肺炎（SARS）病原体核酸扩增（PCR）-荧光检测试剂盒 | | Diagnostic reagent | IVD | New Drug Application | 2003-10-20 | 上海科华生物工程股份有限公司 | Shanghai Kehua Bio-Engineering Co Ltd | Certificate Issued | 2004-01-19 | view |
| X0301971 | 乙型肝炎病毒表面抗原胶体金法诊断试剂盒 | | Diagnostic reagent | IVD | New Drug Application | 2004-03-17 | 上海科华生物工程股份有限公司 | Shanghai Kehua Bio-Engineering Co Ltd | Certificate Issued | 2004-10-29 | view |
| X0301982 | 丙型肝炎病毒核酸扩增（PCR）-荧光定量检测试剂盒 | | Diagnostic reagent | IVD | New Drug Application | 2004-04-20 | 上海科华生物工程股份有限公司 | Shanghai Kehua Bio-Engineering Co Ltd | Certificate Issued | 2004-09-24 | view |
| Y0404540 | 梅毒螺旋体抗体诊断试剂盒(双抗原夹心酶联免疫法) | | Diagnostic reagent | IVD | Supplementary Application | 2004-07-05 | 上海科华生物工程股份有限公司 | Shanghai Kehua Bio-Engineering Co Ltd | Certificate Issued | 2004-10-29 | view |
| X0403530 | 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 | 2004-07-05 | 上海科华生物工程股份有限公司 | Shanghai Kehua Bio-Engineering Co Ltd | Certificate Issued | 2004-08-10 | view |
| X0305597 | HIV核酸扩增（PCR）-荧光检测试剂盒 | | Diagnostic reagent | IVD | New Drug Application | 2004-07-14 | 上海科华生物工程股份有限公司 | Shanghai Kehua Bio-Engineering Co Ltd | Pending Approval | 2005-05-11 | view |
| X0404715 | 新型冠状病毒核酸扩增（PCR）－荧光检测试剂盒 | | Diagnostic reagent | IVD | Supplementary Application | 2004-08-23 | 上海科华生物工程股份有限公司 | Shanghai Kehua Bio-Engineering Co Ltd | In Approval | 2006-07-20 | view |
| X0400556 | 乙型肝炎病毒核心抗体IgM诊断试剂盒（酶联免疫法） | | Diagnostic reagent | IVD | New Drug Application | 2004-08-27 | 上海科华生物工程股份有限公司 | Shanghai Kehua Bio-Engineering Co Ltd | Certificate Issued | 2005-01-31 | view |
| Y0411150 | 甲胎蛋白诊断试剂盒（酶联免疫法） | | Diagnostic reagent | IVD | Generic Drug | 2004-09-30 | 上海科华生物工程股份有限公司 | Shanghai Kehua Bio-Engineering Co Ltd | Certificate Issued | 2005-08-19 | view |
| X0407883 | 人类T淋巴细胞白血病病毒(HTLV)1+2型抗体诊断试剂盒(酶联免疫法) | | Diagnostic reagent | IVD | Supplementary Application | 2004-12-22 | 上海科华生物工程股份有限公司 | Shanghai Kehua Bio-Engineering Co Ltd | Certificate Issued | 2006-04-28 | 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 |
| CYSS0600073 | 戊型肝炎病毒IgM抗体诊断试剂盒（酶联免疫法） | | Diagnostic reagent | IVD | Generic Drug | 2006-09-18 | 上海科华生物工程股份有限公司 | Shanghai Kehua Bio-Engineering Co Ltd | Certificate Completed-Pending Issued | | 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 |
