Layered adhesive protein determination reagent kit (latex immunoturbidimetric method)
- Device class
- Class II
- Model specifications
- 试剂1: 30mL×1 试剂2: 10mL×1; 试剂1: 40mL×3 试剂2: 40mL×1; 试剂1: 60mL×1 试剂2: 20mL×1; 试剂1: 60mL×2 试剂2: 20mL×2; 试剂1: 60mL×3 试剂2: 60mL×1; 校准品:1mL×4(选购); 质控品:1mL×1(选购).试剂1: 30mL×1 试剂2: 10mL×1； 试剂1: 40mL×3 试剂2: 40mL×1； 试剂1: 60mL×1 试剂2: 20mL×1； 试剂1: 60mL×2 试剂2: 20mL×2； 试剂1: 60mL×3 试剂2: 60mL×1； 校准品：1mL×4（选购）； 质控品：1mL×1（选购）。
- Approval department
- Hebei Provincial Drug Administration河北省药品监督管理局
- Registration number
- 冀械注准20242400419
- Approval date
- November 07, 2024
- Expiry date
- November 06, 2029
- Name
- Hebei Archi Biological Technology Co., Ltd.河北艾驰生物科技有限公司
- Province/Region
- Hebei河北
- Address
- No. 789, Juxin Street, Eastern Area, Qian'an Economic Development Zone, Hebei Province河北迁安经济开发区东部片区聚鑫街789号
- Production address
- 河北迁安经济开发区东部片区聚鑫街789号
It is used for the quantitative determination of laminin (LN) content in human serum in vitro.
用于体外定量测定人血清中层粘连蛋白（LN）的含量。
试剂1 三羟甲基氨基甲烷 20mmol/L、聚乙二醇6000 0.3% 试剂2 三羟甲基氨基甲烷 20.0mmol/L、层粘连蛋白小鼠单克隆抗体包被的胶乳微球 1mg/mL 校准品 三羟甲基氨基甲烷 20mmol/L、氯化钠 0.9%、牛血清白蛋白(BSA) 1%、层粘连蛋白 质控品 三羟甲基氨基甲烷 20mmol/L、氯化钠 0.9%、牛血清白蛋白(BSA) 1%、层粘连蛋白
试剂1 三羟甲基氨基甲烷 20mmol/L、聚乙二醇6000 0.3% 试剂2 三羟甲基氨基甲烷 20.0mmol/L、层粘连蛋白小鼠单克隆抗体包被的胶乳微球 1mg/mL 校准品 三羟甲基氨基甲烷 20mmol/L、氯化钠 0.9%、牛血清白蛋白（BSA） 1%、层粘连蛋白 质控品 三羟甲基氨基甲烷 20mmol/L、氯化钠 0.9%、牛血清白蛋白（BSA） 1%、层粘连蛋白
试剂、校准品和质控品2-8℃密闭储存可稳定18个月.
试剂、校准品和质控品2-8℃密闭储存可稳定18个月。
- Appendix
- 产品技术要求、说明书
Access comprehensive regulatory information for Layered adhesive protein determination reagent kit (latex immunoturbidimetric method) in the China medical device market through Pure Global AI's free database. This Class II medical device is registered under NMPA registration number 冀械注准20242400419 and owned by Hebei Archi Biological Technology Co., Ltd.. The device was approved on November 07, 2024.
This page provides complete registration details including registrant information, province location (Hebei), intended use, and regulatory compliance data from the official China NMPA medical device database. Pure Global AI offers free access to China's complete medical device registry, helping global MedTech companies navigate NMPA regulations efficiently.