α-L-Fucosidase Calibration Solution - NMPA Registration 苏械注准20212401282
Access comprehensive regulatory information for α-L-Fucosidase Calibration Solution in the China medical device market through Pure Global AI's free database. This Class II medical device is registered under NMPA registration number 苏械注准20212401282 and owned by Jiangsu MDK BIOTECH Co., Ltd.. The device was approved on September 01, 2021.
This page provides complete registration details including registrant information, province location (Jiangsu), 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 system calibration (class II) for the determination of α-L-fucosidase detection kit (CNPF substrate method) on the supporting detection system of Jiangsu Medeco Biotechnology Co., Ltd.
用于江苏麦得科生物科技有限公司配套检测系统上α-L-岩藻糖苷酶检测试剂盒（CNPF底物法）测定时的系统校准（二类）。
α-L-Fucosidase (Source: Corynebacterium) 32.0±6.4U/L phosphate buffer pH=6.0 100mmol/L sodium chloride(NaCl) 0.15mol/LProClin-300 0.03% Tween-20(Tween20) 0.5%
α-L-岩藻糖苷酶（来源：棒状杆菌属） 32.0±6.4U/L磷酸盐缓冲液pH=6.0 100mmol/L氯化钠（NaCl） 0.15mol/LProClin-300 0.03%吐温-20（Tween20） 0.5%
1. Sealed storage at 2°C~8°C, valid for 12 months. 2. Ready to use, discard after use.
1. 2℃～8℃密封储存，有效期为12个月。2. 即开即用，用后即弃。