N-乙酰-β-D-氨基葡萄糖苷酶测定试剂盒（MPT底物法）

京械注准20172400404

海丰生物科技（北京）有限公司

北京市北京经济技术开发区经海三路35号院3幢1层、2层

北京市北京经济技术开发区经海三路35号院3幢1层、2层

N-乙酰-β-D-氨基葡萄糖苷酶测定试剂盒（MPT底物法）

第二类

<div style="clear: both"> </div><div style="clear: both"> <table align="center" border="1" cellpadding="0" cellspacing="0" style="width: 80%" width="41%"> <tbody> <tr> <td style="width: 468px; height: 19px"> <p align="center"> <span style="font-size: 16px"><span style="font-family: simsun">规 格</span></span></p> </td> </tr> <tr> <td style="width: 468px; height: 19px"> <p align="center"> <span style="font-size: 16px"><span style="font-family: simsun">试剂1: 2&times;60 ml 试剂2: 2&times;20 ml</span></span></p> </td> </tr> <tr> <td style="width: 468px; height: 17px"> &l

<p> </p><table align="center" border="1" cellpadding="0" cellspacing="0" style="width: 80%" width="612"> <tbody> <tr> <td style="width: 75px; height: 21px"> <p> <span style="font-size: 16px"><span style="font-family: simsun">试剂</span></span></p> </td> <td style="width: 328px; height: 21px"> <p> <span style="font-size: 16px"><span style="font-family: simsun">成分</span></span></p> </td> <td style="width: 208px; height: 21px"> <p> <span style="font-size: 16px"><span style="font-family: simsun">浓度</span></span></p> </td> </tr> <tr> <td style="width: 75px; height: 23px"> <p> <span style="font-size: 16px"><span style="font-family: simsun">试剂1</span></span></p> </td> <td style="width: 328px; height: 23px"> <p> <span style="font-size: 16px"><span style="font-family: simsun">柠檬酸缓冲液</span></span></p> </td> <td style="width: 208px; height: 23px"> <p> <span style="font-size: 16px"><span style="font-family: simsun">10mmol/L</span></span></p> </td> </tr> <tr> <td style="width: 75px; height: 63px"> <p> <span style="font-size: 16px"><span style="font-family: simsun">试剂2</span></span></p> </td> <td style="width: 328px; height: 63px"> <p> <span style="font-size: 16px"><span style="font-family: simsun">柠檬酸缓冲液</span></span></p> <p> <span style="font-size: 16px"><span style="font-family: simsun">6-甲基-2-吡啶基 2-(乙酰氨基)-2-脱氧-1-硫代-BETA-D-吡喃葡萄糖苷（MPT-NAG）</span></span></p> </td> <td style="width: 208px; height: 63px"> <p> <span style="font-size: 16px"><span style="font-family: simsun">10mmol/L</span></span></p> <p> </p> <p> <span style="font-size: 16px"><span style="font-family: simsun">15mmol/L</span></span></p> </td> </tr> <tr> <td style="width: 75px; height: 37px"> <p> <span style="font-size: 16px"><span style="font-family: simsun">校准品</span></span></p> </td> <td style="width: 328px; height: 37px"> <p> <span style="font-size: 16px"><span style="font-family: simsun">N-乙酰-&beta;-D-氨基葡萄糖苷酶</span></span></p> <p> <span style="font-size: 16px"><span style="font-family: simsun">proclin-300</span></span></p> <p> <span style="font-size: 16px"><span style="font-family: simsun">柠檬酸缓冲液（pH7.0）</span></span></p> </td> <td style="width: 208px; height: 37px"> <p> <span style="font-size: 16px"><span style="font-family: simsun">目标浓度：42U/L</span></span></p> <p> <span style="font-size: 16px"><span style="font-family: simsun">0.3ml/L</span></span></p> <p> <span style="font-size: 16px"><span style="font-family: simsun">10mmol/L</span></span></p> </td> </tr> <tr> <td style="width: 75px; height: 51px"> <p> <span style="font-size: 16px"><span style="font-family: simsun">质控品</span></span></p> </td> <td style="width: 328px; height: 51px"> <p> <span style="font-size: 16px"><span style="font-family: simsun">N-乙酰-&beta;-D-氨基葡萄糖苷酶</span></span></p> <p> <span style="font-size: 16px"><span style="font-family: simsun">柠檬酸缓冲液（pH7.0）</span></span></p> <p> <span style="font-size: 16px"><span style="font-family: simsun">proclin-300</span></span></p> </td> <td style="width: 208px; height: 51px"> <p> <span style="font-size: 16px"><span style="font-family: simsun">目标浓度：30U/L</span></span></p> <p> <span style="font-size: 16px"><span style="font-family: simsun">10mmol/L</span></span></p> <p> <span style="font-size: 16px"><span style="font-family: simsun">0.3m</span></span>l/L</p> </td> </tr> </tbody></table><div style="clear: both"> <span style="font-family: simsun; font-size: 16px">注：校准品、质控品具有批间、赋值特异性，具体值详见靶值单。</span></div>

<p> <span style="font-family: simsun">本产品适用于体外定量测定人尿液中的N-乙酰-&beta;-D-氨基葡萄糖苷酶含量。</span></p>

2℃～8℃储存，有效期12个月。

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产品技术要求，产品说明书

无

北京市食品药品监督管理局

2017-04-07

2022-04-06

“本产品适用于日立7060/7080/7100/7170/7180/7600生化分析仪；罗氏Cobas c701/702/501/502/311生化分析仪；贝克曼AU2700/AU5400/AU480/AU680/AU5800/DXC800生化分析仪；东芝TBA40FR/TBA120FR生化分析仪；迈瑞BS-400/BS-480/BS-600/BS-800M/BS-2000M生化分析仪；迪瑞CS-400B/CS-600B/CS-1200/CS-1600/CS-6400生化分析仪。 ”变更为“适用于日立7060/7080/7100/7170/7180/7600/7020/3100/3110/3500/LST 008AS/生化分析仪；罗氏Cobas c701/702/501/502/311/P800生化分析仪；贝克曼AU2700/AU5400/AU480/AU680/AU5800/DXC800/AU400/AU640生化分析仪；东芝TBA40FR/TBA120FR/TBA2000FR生化分析仪；迈瑞BS-400/BS-480/ BS-600/BS-800M/BS-2000M/BS-220生化分析仪；迪瑞CS-400B/ CS-600B/CS-1200/CS-1600/CS-6400生化分析仪；西门子SIEMENS-ADVIA1200/SIEMENS-ADVIA1800/SIEMENS-ADVIA2400/SIEMENS-ADVIAChemistryXPT/SIEMENS-DimensionsExl生化分析仪；雅培C8000/C16000生化分析仪；科华1200生化分析仪；希森美康JCA-BM6010/C /BX-3010/BX-4000。”。(批准日期：20200213)<br><p> 生产地址：“北京市北京经济技术开发区经海三路35号院3幢1层、2层”变更为“北京市北京经济技术开发区经海三路35号院3幢1层、2层、406室”。</p>(批准日期：20180118)<br>