降钙素原（PCT）测定试剂盒（荧光免疫层析法）

京械注准20162400659

京械注准20162400659

北京市顺义区后沙峪镇裕民大街甲1号4幢

北京市顺义区后沙峪镇裕民大街甲1号5号楼A座

降钙素原（PCT）测定试剂盒（荧光免疫层析法）

第二类

<p> 10人份/盒，25人份/盒，50人份/盒。</p>

<table border="1" cellpadding="1" cellspacing="1"> <tbody> <tr> <td rowspan="2" style="text-align: center; width: 2%"> <span style="font-size: 14px">编 号</span></td> <td rowspan="2" style="text-align: center"> <span style="font-size: 14px">名 称</span></td> <td rowspan="2" style="text-align: center"> <span style="font-size: 14px">组 分</span></td> <td colspan="3" style="text-align: center"> <span style="font-size: 14px">装 量</span></td> </tr> <tr> <td style="text-align: center"> <span style="font-size: 14px"><span>10人份</span></span></td> <td style="text-align: center"> <span style="font-size: 14px"><span>25人份</span></span></td> <td style="text-align: center"> <span style="font-size: 14px"><span>50人份</span></span></td> </tr> <tr> <td style="width: 7%"> <span style="font-size: 14px"><span>1. </span></span></td> <td style="width: 15%"> <p> <span style="font-size: 14px"><span><span><span style="font-family: simsun">PCT荧光免</span></span></span></span><span style="font-size: 14px"><span><span><span style="font-family: simsun">疫层</span></span></span></span><span style="font-size: 14px"><span><span><span style="font-family: simsun">析检测卡</span></span></span></span></p> </td> <td style="width: 30%"> <p> <span style="font-size: 14px"><span><span><span style="font-family: simsun">检测卡由检测卡壳和试纸条构成，</span></span></span></span></p> <p> <span style="font-size: 14px"><span><span><span style="font-family: simsun">试纸条由样品垫、结合垫（喷有荧</span></span></span></span></p> <p> <span style="font-size: 14px"><span><span><span style="font-family: simsun">光素标记的链霉亲和素和生物素标</span></span></span></span></p> <p> <span style="font-size: 14px"><span><span><span style="font-family: simsun">记的PCT羊多抗Ab1）、包被膜（检</span></span></span></span></p> <p> <span style="font-size: 14px"><span><span><span style="font-family: simsun">测线包被有PCT鼠单抗Ab2），质控</span></span></span></span></p> <p> <span style="font-size: 14px"><span><span><span style="font-family: simsun">线包被有兔抗羊IgG抗体Ab3）、吸</span></span></span></span></p> <p> <span style="font-size: 14px"><span><span><span style="font-family: simsun">水</span></span></span></span><span style="font-size: 14px"><span><span><span style="font-family: simsun">纸、PVC板组成。</span></span></span></span></p> </td> <td style="text-align: center; width: 6%"> <span style="font-size: 14px"><span>10个</span></span></td> <td style="text-align: center; width: 6%"> <span style="font-size: 14px"><span>25个</span></span></td> <td style="text-align: center; width: 6%"> <span style="font-size: 14px"><span>50个</span></span></td> </tr> <tr> <td> <span style="font-size: 14px">2. </span></td> <td> <p style="text-align: center"> <span style="font-size: 14px"><span><span style="font-family: simsun">PCT样品稀</span></span></span><span style="font-size: 14px"><span><span style="font-family: simsun">释液（F）</span></span></span></p> </td> <td> <p> <span style="font-size: 14px"><span><span style="font-family: simsun">含有1%BSA的磷酸缓</span></span></span><span style="font-size: 14px"><span><span style="font-family: simsun">冲盐溶液，</span></span></span></p> <p> <span style="font-size: 14px"><span><span style="font-family: simsun">添加有</span></span></span><span style="font-size: 14px"><span><span style="font-family: simsun">0.2&permil;的Proclin 300。</span></span></span></p> </td> <td> <p style="text-align: center"> <span style="font-size: 14px"><span><span style="font-family: simsun">2.0ml&times;</span></span></span></p> <p style="text-align: center"> <span style="font-size: 14px"><span><span style="font-family: simsun">1瓶</span></span></span></p> </td> <td> <p style="text-align: center"> <span style="font-size: 14px"><span><span style="font-family: simsun">2.0ml&times;</span></span></span></p> <p style="text-align: center"> <span style="font-size: 14px"><span><span style="font-family: simsun">2瓶</span></span></span></p> </td> <td> <p style="text-align: center"> <span style="font-size: 14px"><span><span style="font-family: simsun">4.0ml&times;</span></span></span></p> <p style="text-align: center"> <span style="font-size: 14px"><span><span style="font-family: simsun">2瓶</span></span></span></p> </td> </tr> <tr> <td> <span style="font-size: 14px">3. </span></td> <td> <p style="text-align: center"> <span style="font-size: 14px"><span><span style="font-family: simsun">PCT校准卡</span></span></span></p> </td> <td> <p> <span style="font-size: 14px"><span><span style="font-family: simsun">SD卡内集成本批次产品标</span></span></span><span style="font-size: 14px"><span><span style="font-family: simsun">准</span></span></span></p> <p> <span style="font-size: 14px"><span><span style="font-family: simsun">曲线数据。</span></span></span></p> </td> <td style="text-align: center"> <span style="font-size: 14px">1个</span></td> <td style="text-align: center"> <span style="font-size: 14px">1个</span></td> <td style="text-align: center"> <span style="font-size: 14px">1个</span></td> </tr> </tbody> </table> <p> </p>

<p> 用于体外定量测定人血清、血浆或全血中降钙素原(PCT)含量。</p>

2℃~30℃储存，有效期为8个月。

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北京市食品药品监督管理局

2016-07-15

2021-07-14

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