D-二聚体测定试剂盒（胶乳免疫比浊法）

京械注准20172400056

京械注准20172400056

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

D-二聚体测定试剂盒（胶乳免疫比浊法）

第二类

<p> <span style="font-size: 12px"><span style="font-family: simsun">规格1：(试剂1：15mL；试剂2：5mL)；</span></span></p> <p> <span style="font-size: 12px"><span style="font-family: simsun">规格2：(试剂1：30mL；试剂2：10mL)；</span></span></p> <p> <span style="font-size: 12px"><span style="font-family: simsun">规格3：(试剂1：60mL；试剂2：20mL)；</span></span></p> <p> <span style="font-size: 12px"><span style="font-family: simsun">规格4：(试剂1：90mL；试剂2：30mL)；</span></span></p> <p> <span style="font-size: 12px"><span style="font-family: simsun">校准品(冻干品)：为选配</span></span></p> <p> <span style="font-size: 12px"><span style="font-family: simsun">规格1（0.3mL&times;1；1水平)；规格2（0.5mL&times;1；1水平)

<p> <span style="font-family: simsun"><span style="font-size: 12px"> </span></span></p> <table border="1" cellpadding="0" cellspacing="0" style="width: 312px" width="312"> <tbody> <tr> <td style="width: 66px; height: 26px"> <p align="center"> <span style="font-family: simsun"><span style="font-size: 12px">名称</span></span></p> </td> <td style="width: 132px; height: 26px"> <p align="center"> <span style="font-family: simsun"><span style="font-size: 12px">组成成分</span></span></p> </td> <td style="width: 113px; height: 26px"> <p align="center"> <span style="font-family: simsun"><span style="font-size: 12px">浓度</span></span></p> </td> </tr> <tr> <td style="width: 66px; height: 35px"> <p align="center"> <span style="font-family: simsun"><span style="font-size: 12px">试剂 1</span></span></p> </td> <td style="width: 132px; height: 35px"> <p align="center"> <span style="font-family: simsun"><span style="font-size: 12px">磷酸缓冲液</span></span></p> <p align="center"> <span style="font-family: simsun"><span style="font-size: 12px">Tween 20</span></span></p> <p align="center"> <span style="font-family: simsun"><span style="font-size: 12px">聚乙二醇6000</span></span></p> <p align="center"> <span style="font-family: simsun"><span style="font-size: 12px">Proclin300</span></span></p> </td> <td style="width: 113px; height: 35px"> <p align="center"> <span style="font-family: simsun"><span style="font-size: 12px">50 mmol/L</span></span></p> <p align="center"> <span style="font-family: simsun"><span style="font-size: 12px">0.1%</span></span></p> <p align="center"> <span style="font-family: simsun"><span style="font-size: 12px">0.5%</span></span></p> <p align="center"> <span style="font-family: simsun"><span style="font-size: 12px">0.1%</span></span></p> </td> </tr> <tr> <td style="width: 66px; height: 34px"> <p align="center"> <span style="font-family: simsun"><span style="font-size: 12px">试剂2</span></span></p> </td> <td style="width: 132px; height: 34px"> <p align="center"> <span style="font-family: simsun"><span style="font-size: 12px">磷酸缓冲液</span></span></p> <p align="center"> <span style="font-family: simsun"><span style="font-size: 12px">抗人D-dimer抗体</span></span></p> <p align="center"> <span style="font-family: simsun"><span style="font-size: 12px">的致敏乳胶颗粒</span></span></p> <p align="center"> <span style="font-family: simsun"><span style="font-size: 12px">Proclin300</span></span></p> </td> <td style="width: 113px; height: 34px"> <p align="center"> <span style="font-family: simsun"><span style="font-size: 12px">20 mmol/L</span></span></p> <p align="center"> <span style="font-family: simsun"><span style="font-size: 12px"> </span></span></p> <p align="center"> <span style="font-family: simsun"><span style="font-size: 12px">0.5%</span></span></p> <p align="center"> <span style="font-family: simsun"><span style="font-size: 12px">0.1%</span></span></p> </td> </tr> <tr> <td style="width: 66px; height: 34px"> <p align="center"> <span style="font-family: simsun"><span style="font-size: 12px">校准品</span></span></p> <p align="center"> <span style="font-family: simsun"><span style="font-size: 12px">(选配)</span></span></p> <p align="center"> <span style="font-family: simsun"><span style="font-size: 12px">冻干品</span></span></p> </td> <td style="width: 132px; height: 34px"> <p align="left"> <span style="font-family: simsun"><span style="font-size: 12px">磷酸缓冲液，0.9%NaCl，1%BSA,1%甘露醇,D-二聚体</span></span></p> </td> <td style="width: 113px; height: 34px"> <p align="left"> <span style="font-family: simsun"><span style="font-size: 12px">（20.8&plusmn;4.2）mg/L</span></span></p> <p> <span style="font-family: simsun"><span style="font-size: 12px">每批次靶值详见标签</span></span></p> </td> </tr> <tr> <td style="width: 66px; height: 34px"> <p align="center"> <span style="font-family: simsun"><span style="font-size: 12px">质控品</span></span></p> <p align="center"> <span style="font-family: simsun"><span style="font-size: 12px">（选配）</span></span></p> <p align="center"> <span style="font-family: simsun"><span style="font-size: 12px">冻干品</span></span></p> </td> <td style="width: 132px; height: 34px"> <p align="left"> <span style="font-family: simsun"><span style="font-size: 12px">磷酸缓冲液，0.9%NaCl，1%BSA,1%甘露醇, D-二聚体</span></span></p> </td> <td style="width: 113px; height: 34px"> <p align="left"> <span style="font-family: simsun"><span style="font-size: 12px">(0.6&plusmn;0.12) mg/L</span></span></p> <p align="left"> <span style="font-family: simsun"><span style="font-size: 12px">(12&plusmn;2.4) mg/L</span></span></p> <p> <span style="font-family: simsun"><span style="font-size: 12px">每批次靶值详见标签</span></span></p> </td> </tr> </tbody> </table> <p> <span style="font-family: simsun"><span style="font-size: 12px"> </span></span></p>

<p> <span style="font-size: 12px"><span style="font-family: simsun">本品用于体外定量测定人血浆中D-二聚体（D-dimer）的含量。</span></span></p>

原包装试剂在2℃-8℃下存放有效期为12

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北京市食品药品监督管理局

2017-01-06

2022-01-05

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