α-L-Fucosidase Calibration Solution
- Device class
- Class II
- Model specifications
- 1.0mL/bottle× 1 bottle (1 level)1.0mL/瓶×1瓶（1个水平）
- Approval department
- Jiangsu Provincial Drug Administration江苏省药品监督管理局
- Registration number
- 苏械注准20212401282
- Approval date
- September 01, 2021
- Expiry date
- August 31, 2026
- Name
- Jiangsu MDK BIOTECH Co., Ltd.江苏麦得科生物科技有限公司
- Province/Region
- Jiangsu江苏
- Address
- The third floor of the south building of Gaochuang Park, Shuyang County, Suqian City宿迁市沭阳县高创园南楼三层
- Production address
- 宿迁市沭阳县高创园南楼三层
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。
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.