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25-羟基维生素D测定试剂盒 （胶乳免疫比浊法）
国产
有效
注册
第二类
产品名称：
25-羟基维生素D测定试剂盒 （胶乳免疫比浊法）
注册人名称：
注册(备案)号：
京械注准20212400232
注册人住所：
北京市昌平区科技园区火炬街21号4幢4层401
批准(备案)日期：
2021-05-10
有效期至：
2026-05-09
结构及组成：
组成ttttttttttttttt性状ttttttttttttttt主要成分ttttttttttttttt浓度ttttttttttttttttttt试剂1（R1）ttttttttttttttt液体ttttttttttttttt柠檬酸钠ttttttttttttttt100mmol/Lttttttttttttttttttt氯化钠ttttttttttttttt0.15mol/Lttttttttttttttttttt防腐剂ttttttttttttttt0.03%ttttttttttttttttttt试剂2（R2）ttttttttttttttt液体ttttttttttttttt柠檬酸钠ttttttttttttttt100mmol/Lttttttttttttttttttt牛血清白蛋白ttttttttttttttt1%ttttttttttttttttttt吐温-20ttttttttttttttt1%ttttttttttttttttttt防腐剂ttttttttttttttt0.03%ttttttttttttttttttt包被有抗25-羟基维生素D抗体胶乳颗粒ttttttttttttttt1%ttttttttttttttttttt校准品（选配）ttttttttttttttt冻干粉ttttttttt ttttttttttttttt人血清ttttttttttttttt50%ttttttttttttttttttt三羟甲基氨基甲烷缓冲液ttttttttttttttt50mmol/Lttttttttttttttttttt保护剂ttttttttttttttt5%ttttttttttttttttttt氯化钠ttttttttttttttt0.15mol/Lttttttttttttttttttt防腐剂ttttttttttttttt0.03%ttttttttttttttttttt25-羟基维生素Dttttttttttttttt靶值浓度范围：ttttttttt[130，170] ng/mLttttttttttttttttttt质控品ttttttttt（选配）ttttttttttttttt冻干粉ttttttttttttttt人血清ttttttttttttttt50%ttttttttttttttttttt三羟甲基氨基甲烷缓冲液ttttttttttttttt50mmol/Lttttttttttttttttttt保护剂ttttttttttttttt5%ttttttttttttttttttt氯化钠ttttttttttttttt0.15mol/Lttttttttttttttttttt防腐剂ttttttttttttttt0.03%ttttttttttttttttttt25-羟基维生素Dttttttttttttttt目标浓度范围ttttttttt水平1：[10，30] ng/mLttttttttt水平2：[50，80] ng/mLttttttt校准品靶值批特异，详见校准品瓶签；质控品质控范围批特异，详见质控品瓶签。
适用范围：
用于体外定量测定人血清或血浆中25-羟基维生素D（25-OH VD）的含量。
代理公司：
代理公司地址：
变更情况：
t
生产地址：
北京市昌平区火炬街28号1号楼一层东侧，北京市中关村科技园昌平园火炬街28号1号楼一层西侧B区
型号规格：
试剂1：16mL×1，试剂2：4mL×1ttttttttttttttt试剂1：48mL×4，试剂2：24mL×2ttttttttttttttttttt试剂1：16mL×2，试剂2：4mL×2ttttttttttttttt试剂1：50mL×2，试剂2：25mL×1ttttttttttttttttttt试剂1：16mL×3，试剂2：4mL×3ttttttttttttttt试剂1：50mL×4，试剂2：25mL×2ttttttttttttttttttt试剂1：16mL×8，试剂2：4mL×8ttttttttttttttt试剂1：50mL× 4，试剂2：50mL×1ttttttttttttttttttt试剂1：20mL×1，试剂2：5mL×1ttttttttttttttt试剂1：60mL×1，试剂2：15mL×1ttttttttttttttttttt试剂1：20mL×8，试剂2：5mL×8ttttttttttttttt试剂1：60mL×2，试剂2：15mL×2ttttttttttttttttttt试剂1：40mL×1，试剂2：10mL×1ttttttttttttttt试剂1：60mL×3，试剂2：15mL×3ttttttttttttttttttt试剂1：40mL×2
产品储存条件及有效期：
2℃～8℃避光保存，有效期为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+动态第43批 | 25-羟基维生素D测定试剂盒（胶乳免疫比浊法） | 京械注准20212400232 | 试剂1：60mL×1，试剂2：15mL×1 | 8250.0000 |
| 江西省+动态第43批 | 25-羟基维生素D测定试剂盒（胶乳免疫比浊法） | 京械注准20212400232 | 试剂1：50mL×2，试剂2：25mL×1 | 13750.0000 |
| 山东省医用耗材限价挂网数据 | 25-羟基维生素D测定试剂盒（胶乳免疫比浊法） | 京械注准20212400232 | 试剂1:48mL×2 试剂2:12mL×2 | 21600.0000 |
| 山东省医用耗材限价挂网数据 | 25-羟基维生素D测定试剂盒（胶乳免疫比浊法） | 京械注准20212400232 | 试剂1:60mL×1 试剂2:15mL×1 | 8250.0000 |
| 山东省医用耗材限价挂网数据 | 25-羟基维生素D测定试剂盒（胶乳免疫比浊法） | 京械注准20212400232 | 试剂1:60mL×2 试剂2:15mL×2 | 18000.0000 |
| 2024年12月陕西医用耗材产品目录动态调整挂网结果的公告 | 25-羟基维生素D测定试剂盒（胶乳免疫比浊法） | 京械注准20212400232 | 试剂1:60mL×1 试剂2:15mL×1 | 8250.00 |
| 2024年12月陕西医用耗材产品目录动态调整挂网结果的公告 | 25-羟基维生素D测定试剂盒（胶乳免疫比浊法） | 京械注准20212400232 | 试剂1:48mL×2 试剂2:12mL×2 | 10800.00 |
| 江西省+动态第62批 | 25-羟基维生素D测定试剂盒(胶乳免疫比浊法) | 京械注准20212400232 | 试剂1:60mL×1,试剂2:15mL×1;校准品:1.0mL×1;质控品:水平1:1.0mL×1; | 11250.0000 |
| 江西省+动态第62批 | 25-羟基维生素D测定试剂盒(胶乳免疫比浊法) | 京械注准20212400232 | 试剂1:48mL×2,试剂2:12mL×2 | 21600.0000 |
| 江西省+动态第54批 | 25-羟基维生素D测定试剂盒（胶乳免疫比浊法） | 京械注准20212400232 | 试剂1：40mL×2，试剂2：10mL×2 | 12000.0000 |
