N-Acetyl-β-D-Glucosaminidase Assay Kit (MPT Substrate 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20232400264
- 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 N-acetyl-β-D-glucosasidase activity in human urine samples.
体外定量测定人尿液样本中N-乙酰-β-D-氨基葡萄糖苷酶的活性。
See attached page II
见附页二
The reagent is stored in 2 °C ~ 8 °C closed and protected from light for 18 months, and the storage at 2 °C ~ 8 °C can be stable for 14 days after opening. After opening the bottle of calibrators and quality control products, it can be stable for 14 days when stored in the dark at 2 °C ~ 8 °C.
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14天。校准品、质控品开瓶后2℃～8℃避光贮存可稳定14天。
- Appendix
- 产品技术要求、说明书
Access comprehensive regulatory information for N-Acetyl-β-D-Glucosaminidase Assay Kit (MPT Substrate 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20232400264 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.