α-L-Fucosidase Assay Kit (CNPF Substrate Method) - NMPA Registration 冀械注准20242400385
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.
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.
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。
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
The reagent is stable for 18 months when stored in a closed space at 2-8°C.
试剂2-8℃密闭储存可稳定18个月。