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降钙素原测定试剂盒（磁微粒化学发光法）

国产有效注册第二类

产品名称：

降钙素原测定试剂盒（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20222400124

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PCT鼠抗人单克隆抗体的磁ttttttttt珠（M）（50%新生牛血清，pH7.4）ttttttttt6.0mLttttttttt（2）吖啶酯标记的PCT鼠抗人单克隆ttttttttt抗体（R2）（0.05M Tris缓冲液，tttttttttpH7.4）12.0mLttttttttttttttttttt2tttttttttttttttPCT 定标液1ttttttttttttttt0.3mL×1ttttttttttttttt含1ng/mL PCT抗原的Tris缓冲液ttttttttt（0.02M，pH7.4）ttttttttttttttttttt3tttttttttttttttPCT 定标液2ttttttttttttttt0.3mL×1ttttttttttttttt含60ng/mL PCT抗原的Tris缓冲液ttttttttt（0.02M，pH7.4）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ttttttttttttttttttt5tttttttttttttttPCT 质控品1ttttttttt（选配）ttttttttttttttt0.5mL×1ttttttttttttttt含低浓度PCT抗原（4ng/mL~6ng/mL）的Tris缓冲液ttttttttt（0.02M，pH7.4）ttttttttttttttttttt6tttttttttttttttPCT 质控品2ttttttttt（选配）ttttttttttttttt0.5mL×1ttttttttttttttt含高浓度PCT抗原（64ng/mL~96ng/mL）的Tris缓冲液ttttttttt（0.02M，pH7.4）tttttt 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或血浆中降钙素原（PCT）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