Protein C Assay Kit (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:0.5mL×4(选购); 质控品:0.5mL×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：0.5mL×4（选购）； 质控品：0.5mL×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20242400326
- Approval date
- August 14, 2024
- Expiry date
- August 13, 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, Qian'an High-tech Industrial Development Zone迁安高新技术产业开发区聚鑫街789号
- Production address
- 迁安高新技术产业开发区聚鑫街789号
It is used for in vitro quantitative detection of haptoglobin (HPT) content in human serum.
用于体外定量检测人体血清中触珠蛋白（HPT）的含量。
试剂1 三羟甲基氨基甲烷 20mmol/L、PEG6000 5% 试剂2 三羟甲基氨基甲烷 20mmol/L、羊抗人触珠蛋白多克隆抗体 15% 校准品 三羟甲基氨基甲烷 20 mmol/L、牛血清白蛋白(BSA) 1%、触珠蛋白 质控品 三羟甲基氨基甲烷 20 mmol/L、牛血清白蛋白(BSA) 1%、触珠蛋白
试剂1 三羟甲基氨基甲烷 20mmol/L、PEG6000 5% 试剂2 三羟甲基氨基甲烷 20mmol/L、羊抗人触珠蛋白多克隆抗体 15% 校准品 三羟甲基氨基甲烷 20 mmol/L、牛血清白蛋白（BSA） 1%、触珠蛋白 质控品 三羟甲基氨基甲烷 20 mmol/L、牛血清白蛋白（BSA） 1%、触珠蛋白
The reagent is stable for 18 months when stored in a closed space at 2-8°C.
试剂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 Protein C Assay Kit (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20242400326 and owned by Hebei Archi Biological Technology Co., Ltd.. The device was approved on August 14, 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.