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全程C反应蛋白测定试剂盒（磁微粒化学发光法）

国产有效注册第二类

产品名称：

全程C反应蛋白测定试剂盒（磁微粒化学发光法）

注册人名称：

北京华大吉比爱生物技术有限公司

京械注准20222400126

注册人住所：

北京市海淀区永丰屯538号1号楼236、237室

批准(备案)日期：

2022-03-14

有效期至：

2027-03-13

结构及组成：

编号ttttttttttttttt名称ttttttttttttttt规格ttttttttttttttt主要组成成分ttttttttttttttttttt1ttttttttttttttt试剂包ttttttttttttttt100人份×1ttttttttttttttt每个试剂包包括：ttttttttt（1）包被FITC鼠抗人单克隆抗体的磁珠（M）（0.05M 磷酸盐缓冲液）3.0mL。ttttttttt（2）吖啶酯标记的CRP鼠抗人单克隆抗体（R1）（0.05M Tris缓冲液）7.0mLttttttttt（3）FITC标记的CRP鼠抗人单克隆抗体（R2）（0.05M 磷酸盐缓冲液）14.0mLttttttttt（4）FITC标记的CRP鼠抗人单克隆抗体（R3）（0.05M 磷酸盐缓冲液）14.0mLttttttttttttttttttt2tttttttttttttttCRPttttttttt 定标液1ttttttttttttttt0.3mL×1ttttttttttttttt含1mg/L CRP抗原的0.02M 磷酸盐缓冲液ttttttttttttttttttt3tttttttttttttttCRPttttttttt 定标液2ttttttttttttttt0.3mL×1ttttttttttttttt含100mg/L CRP抗原的0.02M 磷酸盐缓冲液ttttttttttttttttttt4ttttttttttttttt信息卡ttttttttttttttt1ttttttttttttttt信息卡为纸质版二维码，内含产品批号、有效期、主曲线ttttttttttttttttttt5tttttttttttttttCRPttttttttt 质控品1（选配）ttttttttttttttt0.3mL×1ttttttttttttttt含低浓度CRP抗原（1.6~2.4mg/L）的0.02M 磷酸盐缓冲液ttttttttttttttttttt6tttttttttttttttCRPttttttttt 质控品2（选配）ttttttttttttttt0.3mL×1ttttttttttttttt含高浓度CRP抗原（96~144mg/L）的0.02M 磷酸盐缓冲液tttttt t注：定标液、质控品浓度具有批特异性，具体浓度见标签。

适用范围：

用于体外定量测定人血清、血浆中C反应蛋白（CRP）的含量。

生产地址：

北京市顺义区临空经济核心区裕华路28号6号4层，8号2层西侧，12号3层西，12号1层西侧

型号规格：

100人份/盒

产品储存条件及有效期：

2℃~8℃储存，有效期为12个月

管理类别：

第二类