Glycocholic Acid Assay 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×6(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×6（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20242400388
- Approval date
- October 10, 2024
- Expiry date
- October 09, 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 in vitro quantitative detection of glycocholic acid (CG) content in human serum.
用于体外定量检测人体血清中甘胆酸（CG）的含量。
试剂1 三羟甲基氨基甲烷 20mmol/L、甘胆酸-BSA 3.0mg/L、聚乙二醇6000 0.3% 试剂2 三羟甲基氨基甲烷 20mmol/L、甘胆酸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%、甘胆酸钠 质控品 三羟甲基氨基甲烷 20mmol/L、氯化钠 0.9%、甘胆酸钠 注:甘胆酸抗体为小鼠单克隆抗体.
试剂1 三羟甲基氨基甲烷 20mmol/L、甘胆酸-BSA 3.0mg/L、聚乙二醇6000 0.3% 试剂2 三羟甲基氨基甲烷 20mmol/L、甘胆酸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%、甘胆酸钠 质控品 三羟甲基氨基甲烷 20mmol/L、氯化钠 0.9%、甘胆酸钠 注：甘胆酸抗体为小鼠单克隆抗体。
It is stable for 18 months when stored closed at 2-8°C.
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 Glycocholic Acid Assay 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20242400388 and owned by Hebei Archi Biological Technology Co., Ltd.. The device was approved on October 10, 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.