狼疮抗凝物检测试剂盒（凝固法）-京械注准20222400014-器械数据

产品名称：

狼疮抗凝物检测试剂盒（凝固法）

注册人名称：

北京九强生物技术股份有限公司

注册(备案)号：

京械注准20222400014

注册人住所：

北京市海淀区花园东路15号旷怡大厦5层

批准(备案)日期：

2022-01-07

有效期至：

2027-01-06

结构及组成：

筛选试剂LAS（冻干粉）：Tris缓冲液 5g/L，凝血因子X激活剂 25μg/L，磷脂 5ml/L，氯化钙 1.8g/L；确认试剂LAC（冻干粉）：Tris缓冲液 5g/L，凝血因子X激活剂 25μg/L，磷脂 15ml/L，氯化钙 1.8g/L；质控品（冻干粉）：人血浆 ≥50%，目标浓度范围：筛选试剂（LAS）：阴性质控：20～55s、阳性质控：65～125s，确认试剂(LAC)：阴性质控：20～55s、阳性质控：20～55s。t注：不同批号的质控品赋值有差异，详见质控品靶值单。

适用范围：

用于体外定性检测人血浆中的狼疮抗凝物。

变更情况：

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生产地址：

北京市怀柔区雁栖经济开发区雁栖北二街15号

型号规格：

筛选试剂（LAS）ttttttttttttttttttt确认试剂（LAC）ttttttttttttttttttttttttt10×3 mLttttttttttttttttttt10×3 mLttttttttttttttttttttttttt10×2 mLttttttttttttttttttt10×2 mLttttttttttttttttttttttttt10×1 mLttttttttttttttttttt10×1 mLttttttttttttttttttttttttt5×3 mLttttttttttttttttttt5×3 mLttttttttttttttttttttttttt5×2 mLttttttttttttttttttt5×2 mLttttttttttttttttttttttttt5×1 mLttttttttttttttttttt5×1 mLttttttttttttttttttttttttt3×2 mLttttttttttttttttttt3×1 mLttttttttttttttttttttttttt3×5 mLttttttttttttttttttt3×5 mLttttttttttttttttttttttttt5×5 mLttttttttttttttttttt5×5 mLttttttttttttttttttttttttt10×

产品储存条件及有效期：

2℃～8℃密封避光保存，有效期18个月。

管理类别：

第二类

找产品

狼疮抗凝物检测试剂盒（凝固法）