Central Nervous System Specific Protein (S100β) Assay Kit (Chemiluminescence 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20232400415
- Approval date
- December 07, 2023
- Expiry date
- December 06, 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
The concentration of central nervous system-specific protein (S100-β) in human serum and human plasma samples was quantitatively determined in vitro.
体外定量测定人血清、人血浆样本中中枢神经特异蛋白(S100-β)的浓度。
See attached page II
见附页二
This product is stored at 2°C~8°C in a closed and dark place, and the expiration date is 12 months. After reconstitution, the calibrator and quality control can be stable for 7 days when stored at 2 °C ~ 8 °C in the dark, and can be stored at -20 °C for 1 month, and cannot be frozen and thawed repeatedly. If the reagent strip is removed from the box and placed on the instrument, the test should be completed within 2 hours.
本品于2℃～8℃密闭避光保存，有效期为12个月。校准品、质控品复溶后2℃～8℃避光贮存可稳定7天，-20℃保存可稳定1个月，不可反复冻融。如果试剂条从包装盒内取出置于仪器上，需在2h内完成测试。
- Appendix
- 产品技术要求、说明书
Access comprehensive regulatory information for Central Nervous System Specific Protein (S100β) Assay Kit (Chemiluminescence 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20232400415 and owned by Sichuan Xincheng Biological Co., Ltd.. The device was approved on December 07, 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.