葡萄糖-6-磷酸脱氢酶检测试剂盒(速率法)
注册证编号
苏食药监械(准)字2014第2400657号
产品名称
葡萄糖-6-磷酸脱氢酶检测试剂盒(速率法)
型号规格
104ml/盒(R1:2×45ml、R2:2×7ml；R1:2×45ml、R2:1×14ml；R1:1×90ml、R2:1×14ml；R1:3×30ml、R2:1×14ml；R1:3×30ml、R2:2×7ml)、208ml/盒(R1:4×45ml、R2:2×14ml；R1:4×45ml、R2:1×28ml；R1:6×30ml、R2:2×14ml；R1:3×60ml、R2:1×28ml；R1:3×60ml、R2:2×14ml；R1:5×36ml、R2:2×14ml；R1:2×90ml、R2:2×14ml；R1:2×90ml、R2:1×28ml)、312ml/盒(R1:6×45ml、R2:1×42ml；R1:6×45ml、R2:2×21ml；R1:4×67.5ml、R2:2×21ml；R1:5×54ml、R2:2×21ml；R1:3×90ml、R2:2×21ml；R1:3×90ml、R2:1×42ml；R1:9×30ml、R2:2×21ml)
结构及组成
葡萄糖-6-磷酸脱氢酶(G-6-PD)检测试剂盒(速率法)由试剂1(R1)：Tris(三羟甲基氨基甲烷)缓冲液(pH7.6)50mmol/L、葡萄糖-6-磷酸10mmol/L，试剂2(R2)：Tris(三羟甲基氨基甲烷)缓冲液(pH7.6)50mmol/L、辅酶Ⅱ6mmol/L组成。基本参数：试剂空白：试剂(盒)在340nm主波长、1.0cm光径下，试剂空白吸光度应≤0.2，试剂空白吸光度变化率(△A/min)应≤0.01；分析灵敏度：试剂(盒)测试100U/L被测物时，吸光度变化率(△A/min)应≥0.05；线性范围：0~200U/L ，线性相关系数(r)≥0.990；重复性：批内变异系数(CV)≤10%，批间相对偏差(R)≤15%；准确度：相对偏差应在±10%之内。
适用范围
用于人全血红细胞中葡萄糖-6-磷酸脱氢酶活性的体外定量测定。
注：器械注册证相关信息来源国家药品监督管理局（数据具有延迟性）
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