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糖类抗原242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:

糖类抗原242测定试剂盒(磁微粒化学发光法)

注册(备案)号:

京械注准20212400375

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CA242鼠抗人单克隆抗体ttttttttt的磁珠(M)(0.02M磷酸缓冲液)ttttttttt7.0mLttttttttt(2)吖啶酯标记的CA242鼠抗人单ttttttttt克隆抗体(R2)(0.02M磷酸缓冲ttttttttt液)7.0mLttttttttttttttttttt2tttttttttttttttCA242ttttttttt 定标液1ttttttttttttttt0.3mL×1ttttttttttttttt含10U/mL CA242抗原的0.02M磷酸ttttttttt缓冲液ttttttttttttttttttt3tttttttttttttttCA242ttttttttt 定标液2ttttttttttttttt0.3mL×1ttttttttttttttt含150U/mL CA242抗原的0.02M磷ttttttttt酸缓冲液ttttttttttttttttttt4ttttttttttttttt信息卡ttttttttttttttt1ttttttttttttttt信息卡为纸质版二维码,内含产品批ttttttttt号、有效期、主曲线(浓度值及相应ttttttttt的相对发光值)ttttttttttttttttttt5tttttttttttttttCA242ttttttttt 质控品1(选配)ttttttttttttttt0.8mL×1ttttttttttttttt含低浓度CA242抗原的0.02M磷酸缓ttttttttt冲液ttttttttttttttttttt6tttttttttttttttCA242ttttttttt 质控品2(选配)ttttttttttttttt0.8mL×1ttttttttttttttt含高浓度CA242抗原的0.02M磷酸缓ttttttttt冲液ttttttttttttttttttt7ttttttttttttttt靶值表(选配)ttttttttttttttt1ttttttttttttttt包含质控品产品批号、有效期,不同ttttttttt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糖类抗原242(CA242)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