D-二聚体检测试剂盒(胶乳增强免疫比浊法)
注册证编号
苏食药监械(准)字2014第2400669号
产品名称
D-二聚体检测试剂盒(胶乳增强免疫比浊法)
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
D-二聚体(DD)检测试剂盒(胶乳增强免疫比浊法)由试剂1(R1)：磷酸盐缓冲液(PBS)(pH8.5)100mmol/L，试剂2(R2)：抗体致敏胶乳(羊抗人D-二聚体抗体)0.25%组成。基本参数：试剂空白：试剂(盒)在600nm主波长、1.0cm光径下，试剂空白吸光度应≤1.6；分析灵敏度：试剂(盒)测试7.0μg/mL被测物时，吸光度差值(ΔA)≥0.25；线性范围：0～14μg/mL，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
用于人血浆中D-二聚体(DD)含量的体外定量测定。
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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