脂肪酶检测试剂盒(比色法)
注册证编号
苏食药监械(准)字2014第2400655号
型号规格
80ml/盒 ( R1:1×60ml、R2:1×20ml；R1:2×30ml、R2:1×20ml；R1:2×30ml、R2:2×10ml)、100ml/盒( R1:1×75ml、R2:1×25ml；R1:2×37.5ml、R2:1×25ml；R1:3×25ml、R2:2×12.5ml)、200ml/盒(R1:2×75ml、R2:2×25ml；R1:2×75ml、R2:1×50ml；R1:3×50ml、R2:1×50ml； R1:4×37.5ml、R2:2×25ml；R1:6×25ml、R2:4×12.5ml；R1:3×50ml、R2:2×25ml)、 300ml/盒( R1:3×75ml、R2:3×25ml；R1:3×75ml、R2:1×75ml；R1:5×45ml、R2:3×25ml；R1:5×45ml、R2:2×37.5ml；R1:6×37.5ml、R2:3×25ml)
结构及组成
脂肪酶(LPS)检测试剂盒(比色法)由试剂1(R1)：胆酸盐缓冲液(pH8.0)50mmol/L、脱氧胆酸钠1.6mmol/L、氯化钠10mmol/L、共脂肪酶1mg/L、试剂2(R2)：酒石酸缓冲液(pH4.0)10mmol/L、牛磺脱氧胆酸盐8.8mmol/L、1,2-邻-二月桂基-消旋-甘油-3-戊二酸-(6-甲基试卤灵)酯0.20mmol/L组成。基本参数：试剂空白：在570nm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150U/L 被测物时，吸光度变化率(△A/min)≥0.04；线性范围：3.2~300U/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。
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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