微量白蛋白测定试剂盒(免疫比浊法)

京械注准20172400028

京械注准20172400028

北京市通州区中关村科技园区通州园光机电一体化产业基地嘉创路5号1号楼301-303、310-312室

北京市通州区中关村科技园区通州园光机电一体化产业基地嘉创路5号1号楼301-303、310-312室

微量白蛋白测定试剂盒(免疫比浊法)

第二类

<p align="left"> 规格1： (试剂1：20mL；试剂2： 5mL)；</p> <p align="left"> 规格2： (试剂1：40mL；试剂2：10mL)；</p> <p align="left"> 规格3： (试剂1：80mL；试剂2：20mL)；</p> <p align="left"> 校准品（冻干品）：为选配:</p> <p align="left"> 规格1（0.3mL&times;1；1水平)；规格2（0.5mL&times;1；1水平)；</p> <p align="left"> 规格3（1.0mL&times;1；1水平)；</p> <p align="left"> 质控品（冻干品）：为选配</p> <p align="left"> 规格1（0.5mL&times;2；2水平)；规格2（1.0mL&times;2；2水平)。</p>

<table border="1" cellpadding="0" cellspacing="0" style="width: 331px" width="331"> <tbody> <tr> <td style="width: 66px; height: 33px"> <p align="center"> <span style="font-size: 12px"><span style="font-family: simsun">名称</span></span></p> </td> <td style="width: 151px; height: 33px"> <p align="center"> <span style="font-size: 12px"><span style="font-family: simsun">组成成分</span></span></p> </td> <td style="width: 113px; height: 33px"> <p align="center"> <span style="font-size: 12px"><span style="font-family: simsun">浓度</span></span></p> </td> </tr> <tr> <td style="width: 66px; height: 35px"> <p align="center"> <span style="font-size: 12px"><span style="font-family: simsun">试剂1</span></span></p> </td> <td style="width: 151px; height: 35px"> <p align="center"> <span style="font-size: 12px"><span style="font-family: simsun">Tris-HCl缓冲液</span></span></p> <p align="left"> <span style="font-size: 12px"><span style="font-family: simsun"> 氯化钠</span></span></p> <p align="center"> <span style="font-size: 12px"><span style="font-family: simsun">聚乙二醇 6000</span></span></p> <p align="center"> <span style="font-size: 12px"><span style="font-family: simsun">表面活性剂</span></span></p> <p align="center"> <span style="font-size: 12px"><span style="font-family: simsun">Proclin 300</span></span></p> </td> <td style="width: 113px; height: 35px"> <p align="center"> <span style="font-size: 12px"><span style="font-family: simsun">100 mmol/L</span></span></p> <p align="center"> <span style="font-size: 12px"><span style="font-family: simsun">10 mmol/L</span></span></p> <p align="center"> <span style="font-size: 12px"><span style="font-family: simsun">5%</span></span></p> <p align="center"> <span style="font-size: 12px"><span style="font-family: simsun">2%</span></span></p> <p align="center"> <span style="font-size: 12px"><span style="font-family: simsun">0.1%</span></span></p> </td> </tr> <tr> <td style="width: 66px; height: 34px"> <p align="center"> <span style="font-size: 12px"><span style="font-family: simsun">试剂2</span></span></p> <p align="center"> <span style="font-size: 12px"> </span></p> </td> <td style="width: 151px; height: 34px"> <p align="center"> <span style="font-size: 12px"><span style="font-family: simsun">Tris-HCl缓冲液</span></span></p> <p align="center"> <span style="font-size: 12px"><span style="font-family: simsun">抗人尿微量白蛋白mALB特异抗体</span></span></p> <p align="center"> <span style="font-size: 12px"><span style="font-family: simsun">Proclin 300</span></span></p> </td> <td style="width: 113px; height: 34px"> <p align="center"> <span style="font-size: 12px"><span style="font-family: simsun">100mmol/L</span></span></p> <p align="center"> <span style="font-size: 12px"><span style="font-family: simsun">15mg/L</span></span></p> <p align="center"> <span style="font-size: 12px"><span style="font-family: simsun">0.1%</span></span></p> </td> </tr> <tr> <td style="width: 66px; height: 34px"> <p align="center"> <span style="font-size: 12px"><span style="font-family: simsun">校准品（选配）</span></span></p> <p align="center"> <span style="font-size: 12px"><span style="font-family: simsun">冻干品</span></span></p> </td> <td style="width: 151px; height: 34px"> <p align="left"> <span style="font-size: 12px"><span style="font-family: simsun"> 磷酸缓冲液，</span></span><span style="font-size: 12px"><span style="font-family: simsun">0.9%NaCl， 1%甘露</span></span><span style="font-size: 12px"><span style="font-family: simsun">醇，</span><span style="font-family: simsun">白蛋白</span></span></p> </td> <td style="width: 113px; height: 34px"> <p align="left"> <span style="font-size: 12px"><span style="font-family: simsun">(420&plusmn;84) mg/L</span></span></p> <p align="left"> <span style="font-size: 12px"><span style="font-family: simsun">每批次靶值</span></span></p> <p align="left"> <span style="font-size: 12px"><span style="font-family: simsun">详见标签</span></span></p> </td> </tr> <tr> <td style="width: 66px; height: 34px"> <p align="center"> <span style="font-size: 12px"><span style="font-family: simsun">质控品（选配）</span></span></p> <p align="center"> <span style="font-size: 12px"><span style="font-family: simsun">冻干品</span></span></p> </td> <td style="width: 151px; height: 34px"> <p align="left"> <span style="font-size: 12px"><span style="font-family: simsun"> 磷酸缓冲液，</span></span><span style="font-size: 12px"><span style="font-family: simsun">0.9%NaCl， 1%甘露</span></span><span style="font-size: 12px"><span style="font-family: simsun">醇，</span><span style="font-family: simsun">白蛋白</span></span></p> </td> <td style="width: 113px; height: 34px"> <p align="left"> <span style="font-size: 12px"><span style="font-family: simsun">(45&plusmn;9)mg/L</span></span></p> <p align="left"> <span style="font-size: 12px"><span style="font-family: simsun">(90&plusmn;18)mg/L</span></span></p> <p align="left"> <span style="font-size: 12px"><span style="font-family: simsun">每批次靶值</span></span></p> <p align="left"> <span style="font-size: 12px"><span style="font-family: simsun">详见标签</span></span></p> </td> </tr> </tbody> </table> <p> <span style="font-size: 12px"> </span></p>

<p> <span style="font-size: 12px"><span style="font-family: simsun">本品用于体外定量测定人尿液中微量白蛋白的含量。</span></span></p>

原包装试剂在2℃-8℃下存放有效期为12

/

/

/

北京市食品药品监督管理局

2017-01-06

2022-01-05

/