Small and dense LDL cholesterol determination kit (peroxidase method)
- Device class
- Class II
- Model specifications
- See attached page I见附页一
- Approval department
- Sichuan Provincial Drug Administration四川省药品监督管理局
- Registration number
- 川械注准20232400262
- Approval date
- August 17, 2023
- Expiry date
- August 16, 2028
- Name
- Sichuan Xincheng Biological Co., Ltd.四川新健康成生物股份有限公司
- Province/Region
- Sichuan四川
- Address
- No. 101, Tianxin Road, Chengdu High-tech Zone成都市高新区天欣路101号
- Production address
- 成都市高新区天欣路101号2栋（不包含1楼1-6和1-9）和3栋1楼
In vitro quantitative determination of the concentration of small and dense LDL cholesterol in human serum and human plasma samples.
体外定量测定人血清、人血浆样本中小而密低密度脂蛋白胆固醇的浓度。
See attached page II
见附页二
The validity period of the reagent is 18 months when stored in 2°C~8°C and protected from light at 2°C~8°C, and it can be stable for 30 days after opening the bottle at 2°C~8°C. After reconstitution, the calibrator and quality control can be stable for 2 days when stored at 2 °C ~ 8 °C in the dark, and can be stored at -20 °C for one week, and cannot be frozen and thawed repeatedly.
试剂2℃～8℃密闭避光贮存有效期为18个月，开瓶后2℃～8℃避光贮存可稳定30天。校准品、质控品复溶后2℃～8℃避光贮存可稳定2天，-20℃保存可稳定一周，不可反复冻融。
- Appendix
- 产品技术要求、说明书
Access comprehensive regulatory information for Small and dense LDL cholesterol determination kit (peroxidase 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 川械注准20232400262 and owned by Sichuan Xincheng Biological Co., Ltd.. The device was approved on August 17, 2023.
This page provides complete registration details including registrant information, province location (Sichuan), 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.