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β2-微球蛋白测定试剂盒（磁微粒化学发光法）

国产有效注册第二类

产品名称：

β2-微球蛋白测定试剂盒（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20212400368

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：

2021-07-27

有效期至：

2026-07-26

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β2-MG鼠抗人单克隆ttttttttt抗体的磁珠（M）（0.02M磷酸ttttttttt缓冲液）7.0mLttttttttt（2）吖啶酯标记的β2-MG鼠抗ttttttttt人单克隆抗体（R2）（0.02M磷ttttttttt酸缓冲液）7.0mLttttttttttttttttttt2tttttttttttttttβ2-MG定标液1ttttttttttttttt0.3mL×1ttttttttttttttt含0.5μg/mL β2-MG抗原的0.02Mttttttttt磷酸缓冲液ttttttttttttttttttt3tttttttttttttttβ2-MG定标液2ttttttttttttttt0.3mL×1ttttttttttttttt含5μg/mL β2-MG抗原的0.02Mttttttttt磷酸缓冲液ttttttttttttttttttt4ttttttttttttttt信息卡ttttttttttttttt1ttttttttttttttt信息卡为纸质版二维码，内含产ttttttttt品批号、有效期、主曲线（浓度ttttttttt值及相应的相对发光值）ttttttttttttttttttt5tttttttttttttttβ2-MG质控品1（选配）ttttttttttttttt0.8mL×1ttttttttttttttt含低浓度β2-MG抗原的0.02M磷ttttttttt酸缓冲液ttttttttttttttttttt6tttttttttttttttβ2-MG质控品2（选配）ttttttttttttttt0.8mL×1ttttttttttttttt含高浓度β2-MG抗原的0.02M磷ttttttttt酸缓冲液ttttttttttttttttttt7ttttttttttttttt靶值表（选配）ttttttttttttttt1ttttttttttttttt包含质控品产品批号、有效期，ttttttttt不同质控水平的靶值范围tttttt 注：定标液浓度具有批特异性，具体浓度见标签。质控品浓度具有批特异性，具体浓度见靶值表。

适用范围：

用于体外定量测定人血清或血浆中β2-微球蛋白（β2-MG）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