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胰岛素测定试剂盒（化学发光免疫分析法）

国产有效注册第二类

产品名称：

胰岛素测定试剂盒（化学发光免疫分析法）

注册人名称：

北京丹大生物技术有限公司

京械注准20222400324

注册人住所：

北京市北京经济技术开发区(通州)环科中路2号院19号楼1至3层101

批准(备案)日期：

2022-08-09

有效期至：

2027-08-08

结构及组成：

名称ttttttttttttttt组成成分ttttttttttttttt装量ttttttttttttttttttt试剂Mttttttttttttttt包被着抗胰岛素抗体的超顺磁性微粒，＞0.1 g/LtttttttttTris缓冲液，50mmol/LtttttttttProclin 300，0.1%ttttttttttttttt50人份：3mL;ttttttttt100人份：6mLttttttttttttttttttt试剂1ttttttttttttttt抗胰岛素抗体-碱性磷酸酶标记物，＞0.1mg/LtttttttttMES缓冲液，50 mmol/LtttttttttProclin 300，0.51%ttttttttttttttt50人份：3mL;ttttttttt100人份：6mLttttttttttttttttttt校准品ttttttttt（3水平，选配）ttttttttttttttt含胰岛素，稳定剂，防腐剂ttttttttt目标浓度：tttttttttS1：4-6μIU/mL；tttttttttS2：80-120μIU/mL；tttttttttS3：400-600μIU/mLttttttttttttttt1mLttttttttttttttttttt试剂曲线ttttttttt二维码ttttttttttttttt载有主校准曲线信息ttttttttttttttt/tttttt注：校准品赋值具有批特异性，每批次靶值详见标签。

适用范围：

用于体外定量测定人血清或血浆中胰岛素的含量。

生产地址：

北京市通州区环科中路2号院19号楼-1至3层

型号规格：

50人份/盒；100人份/盒tt校准品：(3水平，选配），3×1.0mL

产品储存条件及有效期：

试剂在2℃～8℃条件下存放有效期为12个

管理类别：

第二类