血管内皮生长因子测定试剂盒(化学发光免疫分析法)

国产有效注册第二类

产品名称：

注册人名称：

北京健平金星医疗器械有限公司

京械注准20212400516

注册人住所：

北京市海淀区永丰路5号院2号楼2层201-1房间

批准(备案)日期：

2021-09-23

有效期至：

2026-09-22

结构及组成：

序号ttttttttttttttt名称ttttttttttttttt组成成分ttttttttttttttt48人份/盒ttttttttttttttt96人份/盒ttttttttttttttttttt1.ttttttttttttttt包被微孔板ttttttttttttttt鼠抗人VEGF单克隆抗体，基因重组VEGF受体，ttttttttttttttt48孔×1块ttttttttttttttt96孔×1块ttttttttttttttttttt2.tttttttttttttttVEGF校准品ttttttttttttttt冻干品，基因重组VEGF抗原，tttttttttPB缓冲液；目标浓度：800pg/mLttttttttttttttt1瓶ttttttttttttttt2瓶ttttttttttttttttttt3.ttttttttttttttt样品稀释液ttttttttttttttt牛血清白蛋白，PB缓冲液ttttttttttttttt6mL×1瓶 ttttttttttttttt11mL×1瓶ttttttttttttttttttt4.ttttttttttttttt浓缩洗液ttttttttttttttt吐温-20，PB缓冲液ttttttttttttttt25mL×1瓶ttttttttttttttt50mL×1瓶ttttttttttttttttttt5.ttttttttttttttt酶标抗体工作液ttttttttttttttt辣根过氧化物酶标记的鼠抗人VEGF单克隆抗体ttttttttttttttt6mL×1瓶ttttttttttttttt11mL×1瓶ttttttttttttttttttt6.ttttttttttttttt化学发光底物A液ttttttttttttttt过氧化脲，硼酸盐缓冲液ttttttttttttttt3mL×1瓶 ttttttttttttttt6mL×1瓶ttttttttttttttttttt7.ttttttttttttttt化学发光底物B液ttttttttttttttt鲁米诺，硼酸盐缓冲液ttttttttttttttt3mL×1瓶 ttttttttttttttt6mL×1瓶ttttttttttttttttttt8.ttttttttttttttt质控品QC1ttttttttttttttt冻干品，基因重组VEGF抗原，ttttttttt浓度范围（160~240）pg/mLttttttttttttttt1瓶ttttttttttttttt1瓶ttttttttttttttttttt9.ttttttttttttttt质控品QC2ttttttttttttttt冻干品，基因重组VEGF抗原，ttttttttt浓度范围（320~480）pg/mLttttttttttttttt1瓶ttttttttttttttt1瓶ttttttttttttttttttt10.ttttttttttttttt自封袋ttttttttttttttt--------ttttttttttttttt1个ttttttttttttttt1个ttttttttttttttttttt11.ttttttttttttttt封板膜ttttttttttttttt--------ttttttttttttttt2张ttttttttttttttt2张tttttt注：校准品和质控品具有批特异性，具体浓度见标签。

适用范围：

本试剂盒用于体外定量测定人血清中血管内皮生长因子的含量。

代理公司：

代理公司地址：

变更情况：

t注册人名称：“北京健平金星生物科技有限公司”变更为“北京健平金星医疗器械有限公司”。

(批准日期：20220610)

生产地址：

永丰路5号院2号楼2层201-1房间

型号规格：

96 人份/盒；48 人份/盒

产品储存条件及有效期：

试剂盒在2℃～8℃避光保存，有效期为12

管理类别：

第二类

备注：

挂网信息

数据来源	注册备案名	注册证编号	型号规格	挂网报价
湖南医用耗材拟挂产品公示（第二十八批）	血管内皮生长因子测定试剂盒（化学发光免疫分析法）	京械注准20212400516	48人份/盒,96人份/盒	260