β2微球检测试剂盒(比浊法)
注册证编号
苏食药监械(准)字2013第2400359号
型号规格
100ml/盒(R1:1×80ml、R2:1×20ml;R1:2×40ml、R2:1×20ml;R1:4×20ml、R2:2×10ml)200ml/盒(R1:2×80ml、R2:2×20ml;R1:4×40ml、R2:2×20ml;R1:4×40ml、R2:1×40ml;R1:2×80ml、R2:1×40ml;R1:8×20ml、R2:4×10ml)300ml/盒(R1:3×80ml、R2:3×20ml;R1:4×60ml、R2:3×20ml;R1:6×40ml、R2:3×20ml;R1:6×40ml、R2:2×30ml;R1:4×60ml、R2:1×60ml)
结构及组成
β2-微球检测试剂盒(比浊法)由试剂1氯化铵溶液0.2m(含0.95g/L叠氮钠)和剂2(免疫球蛋白致敏胶乳微粒,效价不低于1:8)组成。基本参数:试剂空白吸光度≤1.4 OD值;线性范围0.4-18mg/L(血清)、0-3 mg/L(尿液),r≥0.99;批内精密度CV≤5%;批间差R≤8%;准确度:相对偏差应在±10%之内。
适用范围
用于人血清或尿液中β2-微球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)