Pure Global
冀械注准20242400385

α-L-Fucosidase Assay Kit (CNPF Substrate Method)

α-L-岩藻糖苷酶测定试剂盒（CNPF底物法）
Hebei Archi Biological Technology Co., Ltd.·Class II·NMPA·Approved October 10, 2024
Device classification
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×1(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×1（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 information
Registration number
冀械注准20242400385
Approval date
October 10, 2024
Expiry date
October 09, 2029
Registrant
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, Qian'an High-tech Industrial Development Zone
迁安高新技术产业开发区聚鑫街789号
Production facility
Production address
迁安高新技术产业开发区聚鑫街789号
Intended use
English

It is used for in vitro quantitative detection of the content of α-L-fucosidase (AFU) in human serum, which cannot be used as the basis for early diagnosis or diagnosis of malignant tumors, and cannot be used for tumor screening in the general population.

中文

用于体外定量检测人体血清中α-L-岩藻糖苷酶（AFU）的含量，不能作为恶性肿瘤早期诊断或确诊的依据，不能用于普通人群的肿瘤筛查。

Structure and composition
English

试剂1 柠檬酸三钠 50mmol/L 氯化钠 0.9% 试剂2 柠檬酸三钠 50 mmol/L 2-氯-4-硝基苯-α-L-岩藻糖苷 0.1% 校准品 α-L-岩藻糖苷酶 质控品 α-L-岩藻糖苷酶

Storage conditions and expiration
English

The reagent is stable for 18 months when stored in a closed space at 2-8°C.

中文

试剂2-8℃密闭储存可稳定18个月。

Additional information
Appendix
产品技术要求、说明书
About this record

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 冀械注准20242400385 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.