C肽测定试剂盒（胶乳免疫比浊法）

国产有效注册第二类

产品名称：

C肽测定试剂盒（胶乳免疫比浊法）

注册人名称：

北京世纪沃德生物科技有限公司

京械注准20212400233

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1ttttttttt（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2ttttttttt（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C肽抗体胶乳颗粒ttttttttttttttt0.5%ttttttttttttttttttt校准品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防腐剂ttttttttttttttt0.03%ttttttttttttttttttt保护剂ttttttttttttttt5%ttttttttttttttttttt氯化钠ttttttttttttttt0.15mol/LtttttttttttttttttttC肽ttttttttttttttt靶值浓度范围：ttttttttt（85，135）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防腐剂ttttttttttttttt0.03%ttttttttttttttttttt保护剂ttttttttttttttt5%ttttttttttttttttttt氯化钠ttttttttttttttt0.15mol/LtttttttttttttttttttC肽ttttttttttttttt目标浓度范围：ttttttttt水平1：（1，11） ng/mLttttttttt水平2：（15，35） 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中C肽（C-P）的含量。

代理公司：

代理公司地址：

变更情况：

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1：15mL×1 ，试剂2：5mL×1ttttttttttttttt试剂1：48mL×4 ，试剂2：16mL×4ttttttttttttttttttt试剂1：15mL×2 ，试剂2：5mL×2ttttttttttttttt试剂1：45mL×1 ，试剂2：15mL×1ttttttttttttttttttt试剂1：15mL×4 ，试剂2：5mL×4ttttttttttttttt试剂1：45mL×2 ，试剂2：15mL×2ttttttttttttttttttt试剂1：18mL×3 ，试剂2：6mL×3ttttttttttttttt试剂1：45mL×2 ，试剂2：30mL×1ttttttttttttttttttt试剂1：18mL×5 ，试剂2：6mL×5ttttttttttttttt试剂1：45mL×3，试剂2：15mL×3ttttttttttttttttttt试剂1：30mL×1 ，试剂2：10mL×1ttttttttttttttt试剂1：45mL×4 ，试剂2：30mL×2ttttttttttttttttttt试剂1：30mL×2 ，试剂2：10mL×2ttttttttttttttt试剂1：50mL× 3，试剂2：50mL×1ttttttttttttttttttt试剂1：30m

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	C肽测定试剂盒（胶乳免疫比浊法）	京械注准20212400233	试剂1：45mL×1，试剂2：15mL×1	4800.0000
江西省+动态第43批	C肽测定试剂盒（胶乳免疫比浊法）	京械注准20212400233	试剂1：60mL×1，试剂2：20mL×1	6400.0000
山东省医用耗材限价挂网数据	C肽测定试剂盒（胶乳免疫比浊法）	京械注准20212400233	试剂1:60mL×2 试剂2:20mL×2	12800.0000
山东省医用耗材限价挂网数据	C肽测定试剂盒（胶乳免疫比浊法）	京械注准20212400233	试剂1:60mL×1 试剂2:20mL×1	6400.0000
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	C肽测定试剂盒（胶乳免疫比浊法）	京械注准20212400233	试剂1:60mL×1 试剂2:20mL×1	5760.00
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	C肽测定试剂盒（胶乳免疫比浊法）	京械注准20212400233	试剂1:48mL×1 试剂2:16mL×1	5120.00
江西省+动态第62批	C肽测定试剂盒(胶乳免疫比浊法)	京械注准20212400233	试剂1:60mL×1,试剂2:20mL×1;校准品:1.0mL×1;质控品:水平1:1.0mL×1;	7680.0000
江西省+动态第62批	C肽测定试剂盒(胶乳免疫比浊法)	京械注准20212400233	试剂1:48mL×1,试剂2:16mL×1	5120.0000
江西省+动态第54批	C肽测定试剂盒（胶乳免疫比浊法）	京械注准20212400233	试剂1：30mL×2，试剂2：10mL×2	6400.0000
湖南医用耗材拟挂产品公示（第二十九批）	C 肽测定试剂盒（胶乳免疫比浊法）	京械注准20212400233	试剂1：48mL×2，试剂2：16mL×2	15360