糖类抗原125测定试剂盒（磁微粒化学发光法）-京械注准20212400372-器械数据

产品名称：

糖类抗原125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

注册(备案)号：

京械注准20212400372

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CA125鼠抗人单克隆抗体ttttttttt的磁珠（M）（0.02M磷酸盐缓冲ttttttttt液）7.0mLttttttttt（2）吖啶酯标记的CA125鼠抗人单ttttttttt克隆抗体（R2）（0.01M磷酸盐缓ttttttttt冲液）7.0mLttttttttttttttttttt2tttttttttttttttCA125ttttttttt 定标液1ttttttttttttttt0.3mL×1ttttttttttttttt含50U/mL CA125抗原的0.02M磷酸ttttttttt盐缓冲液ttttttttttttttttttt3tttttttttttttttCA125ttttttttt 定标液2ttttttttttttttt0.3mL×1ttttttttttttttt含1000U/mL CA125抗原的0.02M磷ttttttttt酸盐缓冲液ttttttttttttttttttt4ttttttttttttttt信息卡ttttttttttttttt1ttttttttttttttt信息卡为纸质版二维码，内含产品ttttttttt批号、有效期、主曲线（浓度值及ttttttttt相应的相对发光值）ttttttttttttttttttt5tttttttttttttttCA125ttttttttt 质控品1（选配）ttttttttttttttt0.8mL×1ttttttttttttttt含低浓度CA125抗原的0.02M磷酸盐ttttttttt缓冲液ttttttttttttttttttt6tttttttttttttttCA125ttttttttt 质控品2（选配）ttttttttttttttt0.8mL×1ttttttttttttttt含高浓度CA125抗原的0.02M磷酸盐ttttttttt缓冲液ttttttttttttttttttt7ttttttttttttttt靶值表（选配）ttttttttttttttt1ttttttttttttttt包含质控品产品批号、有效期，不ttttttttt同质控水平的靶值范围tttttt t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糖类抗原125（CA125）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

找产品

糖类抗原125测定试剂盒（磁微粒化学发光法）