激素复合质控品

国产有效注册第二类

产品名称：

激素复合质控品

注册人名称：

北京华大吉比爱生物技术有限公司

京械注准20212400376

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2ttttttttttttttttttt1ttttttttttttttt激素ttttttttt低值质控品ttttttttttttttt0.6mL×3ttttttttttttttt0.6mL×10tttttttttttttttAMH：[0.40，ttttttttt0.60]ng/mLtttttβ-HCG：[20.00，30.00]tttttttttmIU /mLtttttFSH：[12.00，ttttttttt18.00] mIU /mLtttttLH：[8.00，ttttttttt12.00] mIU /mLtttttP：[1.00，1.50]tttttttttng/mLttttttttttttttt含不同浓度抗ttttttttt缪勒氏管激素ttttttttt（AMH）、β-ttttttttt人绒毛膜促性ttttttttt腺激素（β-tttttttttHCG）、促卵ttttttttt泡生成激素ttttttttt（FSH）、促ttttttttt黄体生成素ttttttttt（LH）抗原及ttttttttt孕酮（P）的tttttttttTris缓冲液ttttttttt（0.02M，tttttttttpH7.2）的冻干ttttttttt制品ttttttttttttttttttt2ttttttttttttttt激素ttttttttt高值质控品ttttttttttttttt0.6mL×3ttttttttttttttt0.6mL×10tttttttttttttttAMH：[12.00，ttttttttt18.00]ng/mLtttttβ-HCG：[160.00，ttttttttt240.00]mIU /mLtttttFSH：[32.00，ttttttttt48.00] mIU /mLtttttLH：[120.00，ttttttttt180.00] mIU /mLtttttP：[16.00，ttttttttt24.00] ng/mLttttttttttttttttttt3ttttttttttttttt质控品信息卡ttttttttttttttt1ttttttttttttttt1ttttttttttttttt---ttttttttttttttt信息卡为纸ttttttttt质版二维ttttttttt码，内含产ttttttttt品批号、有ttttttttt效期、靶值ttttttttt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：

激素复合质控品与本公司生产的试剂盒配套使用，用于抗缪勒氏管激素（AMH）、β-人绒毛膜促性腺激素（β-HCG）、促卵泡生成激素（FSH）、促黄体生成素（LH）、孕酮（P）共5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	激素复合质控品	京械注准20212400376	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	3200.0000