器械数据库

缺血修饰白蛋白检测试剂盒(ACB法)

注册证信息下载
注册证编号
苏械注准20162401341
注册人名称
苏械注准20162401341
注册人住所
南京市雨花台区西善桥南路108号2号楼
生产地址
南京市雨花台区西善桥南路108号2号楼
产品名称
缺血修饰白蛋白检测试剂盒(ACB法)
管理类别
第二类
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;R1:2×37.5ml、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; R1:4×37.5ml、R2:4×12.5ml);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
R1:三羟甲基氨基甲烷(Tris)缓冲液(pH 8.1) 30mmol/L, CoSO4 1mmol/L;R2:二硫苏糖醇(DTT) 1mmol/L
适用范围
本品用于体外定量检测人血清中缺血修饰白蛋白的含量。
产品储存条件及有效期
2~8℃避光保存,生产日期起12个月内稳定。开瓶后2~8℃避光保存可稳定15天。
备注
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附件
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其他内容
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审批部门
江苏省药品监督管理局
批准日期
2017-12-04
有效期至
2021-11-30
变更情况
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