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China NMPA legacy archive 苏械注准20212401282

α-L-Fucosidase Calibration Solution

α-L-岩藻糖苷酶校准品
Jiangsu MDK BIOTECH Co., Ltd.Class IINMPAApproved September 01, 2021
Static archiveNMPA · legacy registration snapshot
Device classification
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 information
Registration number
苏械注准20212401282
Approval date
September 01, 2021
Expiry date
August 31, 2026
Registrant
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 facility
Production address
宿迁市沭阳县高创园南楼三层
Intended use
English

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.

中文

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)。

Structure and composition
English

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%

中文

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%

Storage conditions and expiration
English

1. Sealed storage at 2°C~8°C, valid for 12 months. 2. Ready to use, discard after use.

中文

1. 2℃~8℃密封储存,有效期为12个月。2. 即开即用,用后即弃。

About this record

This static archive preserves historical registration fields and translations for α-L-Fucosidase Calibration Solution, registration 苏械注准20212401282. It does not establish current authorization or complete current product details.

The default China search uses the separately verified domestic-registration listing, checked daily. Its published listing fields and scope differ from this older snapshot.