抗链球菌溶血素O（ASO）抗体检测试剂盒（胶体金法）

京械注准20162400268

蓝十字生物药业（北京）有限公司

北京市昌平区科技园区中兴路10号B201室

北京市昌平区北七家科技园

抗链球菌溶血素O（ASO）抗体检测试剂盒（胶体金法）

第二类

<p align="left" class="MsoNormal" style="text-align: left; line-height: 17pt; margin: 0cm 0cm 0pt; mso-line-height-rule: exactly"> <span style="font-size: 14px"><span style="font-family: simsun">条型：单人份<span lang="EN-US">/</span>袋；<span style="font-family: times new roman, times, serif"><span lang="EN-US">25</span></span>人份<span lang="EN-US">/</span>筒</span></span></p><p align="left" class="MsoNormal" style="text-align: left; line-height: 17pt; margin: 0cm 0cm 0pt; mso-line-height-rule: exactly"> <span style="font-size: 14px"><span style="font-family: simsun">板型：单支<span lang="EN-US">/</span>袋，<span style="font-family: times new roman, times, serif"><span lang="EN-US">10</span></s

<p> <span style="font-size: 14px"><span style="font-family: simsun"><span style="mso-font-kerning: 1.0pt; mso-ansi-language: EN-US; mso-fareast-language: ZH-CN; mso-bidi-language: AR-SA">试剂系由链球菌溶血素<span style="font-family: times new roman, times, serif"><span lang="EN-US">O</span></span>抗原和抗鼠<span style="font-family: times new roman, times, serif"><span lang="EN-US">IgG</span></span>多克隆抗体分别固相于硝酸纤维膜，并与胶</span></span><span style="font-family: simsun"><span style="mso-font-kerning: 1.0pt; mso-ansi-language: EN-US; mso-fareast-language: ZH-CN; mso-bidi-language: AR-SA">体金标记的抗人<span style="font-family: times new roman, times, serif"><span lang="EN-US">IgG</span></span>单克隆抗体（固相）制成。稀释液成分：磷酸盐缓冲液<span style="font-family: times new roman, times, serif">（<span lang="EN-US">PBS</span>）</span></span></span><span style="font-family: simsun"><span style="mso-font-kerning: 1.0pt; mso-ansi-language: EN-US; mso-fareast-language: ZH-CN; mso-bidi-language: AR-SA"><span style="font-family: times new roman, times, serif"><span lang="EN-US">0.01 mol/L</span></span>，<span style="font-family: times new roman, times, serif"><span lang="EN-US">pH 7.4</span></span>。</span></span></span></p><br>

<p> <span style="font-size: 14px"><span style="font-family: simsun">可定性检测人血清/血浆/全血样本中的抗链球菌溶血素<span style="font-family: times new roman, times, serif">O</span>抗体，用于<span style="font-family

4℃~30℃避光密封干燥贮存，切勿冰冻。

原注册证号：京药监械（准）字2012第2400533号

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经咨询中国食品药品检定研究院，抗链球菌溶血素O（ASO）抗体检测目前没有国家标准品、参考品发布或更新，因此该产品的延续注册本公司并不出具相应的检验报告。

北京市食品药品监督管理局

2016-03-18

2021-03-17

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