α-L-fucosidase assay kit (CNPF substrate method)
- Device class
- Class II
- Approval department
- Beijing Municipal Drug Administration北京市药品监督管理局
- Registration number
- 京械注准20212400526
- Approval date
- October 18, 2021
- Expiry date
- October 17, 2026
- Name
- Beijing Beijian Xinchuangyuan Biotechnology Co., Ltd.北京北检·新创源生物技术有限公司
- Province/Region
- Beijing北京
- Address
- 1-5-1, 1st to 2nd floor, Building 1, No. 18 Keyuan Road, Daxing District Industrial Development Zone, Beijing北京市大兴区工业开发区科苑路18号1幢1至2层1-5-1
- Production address
- 北京市大兴区工业开发区科苑路18号1幢1至2层1-5-1
This product is used for the in vitro quantitative determination of alpha in human serum; -L-Fucosidase activity.
本产品用于体外定量测定人血清中alpha;-L-岩藻糖苷酶的活性。
Reagent 1: Buffer ge; 20mmol/L Reagent 2: 2-Chloro-4-nitrobenzene-alpha; -L-Fucoside le; 40mmol/L Calibrator (optional): Bovine serum albumin 50g/L alpha; -L-Fucosidase (20.0~60.0)U/L Quality control (optional): Bovine serum albumin 50g/L alpha; -L-Fucosidase Level 1: (20.0~50.0)U/L Level 2: (50.1~150.0) U/L There are batch-to-batch differences between calibrators and quality control products, and the specific concentrations are shown in the target value table.
试剂1： 缓冲液 ge;20mmol/L 试剂2： 2-氯-4-硝基苯-alpha;-L-岩藻糖苷 le;40mmol/L 校准品（选配）： 牛血清白蛋白 50g/L alpha;-L-岩藻糖苷酶 (20.0～60.0)U/L 质控品（选配）： 牛血清白蛋白 50g/L alpha;-L-岩藻糖苷酶 水平1：(20.0～50.0)U/L 水平2：(50.1～150.0)U/L 校准品、质控品有批间差异，具体浓度见靶值表。
2 °C ~ 8 °C protected sealed storage, valid for 12 months.
2℃～8℃避光密封储存，有效期12个月。
- Appendix
- 产品技术要求、说明书
Access comprehensive regulatory information for α-L-fucosidase assay kit (CNPF 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 京械注准20212400526 and owned by Beijing Beijian Xinchuangyuan Biotechnology Co., Ltd.. The device was approved on October 18, 2021.
This page provides complete registration details including registrant information, province location (Beijing), 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.