胃蛋白酶原I/胃蛋白酶原Ⅱ/胃泌素17复合质控品

国产有效注册第二类

产品名称：

注册人名称：

北京华大吉比爱生物技术有限公司

京械注准20212400379

注册人住所：

北京市海淀区永丰屯538号1号楼236、237室

批准(备案)日期：

2021-07-27

有效期至：

2026-07-26

结构及组成：

序号ttttttttttttttt名称ttttttttttttttt规格ttttttttttttttt靶值范围ttttttttttttttt成分ttttttttttttttttttt规格1ttttttttttttttt规格2ttttttttttttttttttt1tttttttttttttttPGⅠ/PGⅡ/ G-17ttttttttt低值质控品ttttttttttttttt0.6mL×3ttttttttttttttt0.6mL×10tttttttttttttttPGⅠ：[16.00，ttttttttt24.00]ng/mLtttttttttPGⅡ：[16.00，ttttttttt24.00]ng /mLtttttttttG-17：[32.00，ttttttttt48.00]pg/mLttttttttttttttt含不同浓度胃蛋ttttttttt白酶原Ⅰ、胃蛋ttttttttt白酶原Ⅱ、胃泌ttttttttt素17抗原的Tristtttttttt缓冲（0.02M，tttttttttpH7.2）的冻干制ttttttttt品ttttttttttttttttttt2tttttttttttttttPGⅠ/PGⅡ/ G-17ttttttttt高值质控品ttttttttttttttt0.6mL×3ttttttttttttttt0.6mL×10tttttttttttttttPGⅠ：[52.00，ttttttttt78.00]ng/mLtttttttttPGⅡ：[48.00，ttttttttt72.00]ng /mLtttttttttG-17：[80.00，ttttttttt120.00]pg/mLttttttttttttttttttt3ttttttttttttttt质控品信息卡ttttttttttttttt1ttttttttttttttt1ttttttttttttttt-ttttttttttttttt信息卡为纸质版ttttttttt二维码，内含产ttttttttt品批号、有效ttttttttt期、靶值范围tttttt注：质控品具有批特异性，具体浓度见质控品信息卡。

适用范围：

该复合质控品与本公司生产的试剂盒配套使用，用于胃蛋白酶原I（PGⅠ）、胃蛋白酶原Ⅱ（PGⅡ）、胃泌素17（G-17）共3个项目的室内质量控制。

代理公司：

代理公司地址：

变更情况：

生产地址：

北京市顺义区临空经济核心区裕华路28号6号4层，8号2层西侧，12号3层西，12号1层西侧

型号规格：

规格1：低值质控品：0.6mL（冻干制品，复溶体积）×3/盒，高值质控品：0.6mL（冻干制品，复溶体积）×3/盒；t规格2：低值质控品：0.6mL（冻干制品，复溶体积）×10/盒，高值质控品：0.6mL（冻干制品，复溶体积）×10/盒。

产品储存条件及有效期：

2℃～8℃储存，有效期12个月。

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
江西省+耗材挂网采购项目	胃蛋白酶原 I胃蛋白酶原Ⅱ胃泌素 17 复合质控品	京械注准20212400379	规格1：低值质控品：0.6mL（冻干制剂，复溶体积）×3\|盒；高值质控品：0.6mL（冻干制剂，复溶体积）×3\|盒	1500.0000