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China NMPA legacy archive 苏械注准20212401563

Specific Growth Factor Quality Control Reagent

特异性生长因子质控品
Jiangsu MDK BIOTECH Co., Ltd.Class IINMPAApproved November 17, 2021
Static archiveNMPA · legacy registration snapshot
Device classification
Device class
Class II
Model specifications
1mL/bottle × 2 bottles (2 levels)
1mL/瓶×2瓶(2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20212401563
Approval date
November 17, 2021
Expiry date
November 16, 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

The product is used with the specific growth factor detection kit (chemical method) produced by Jiangsu Medeco Biotechnology Co., Ltd. For in-room quality control in clinical laboratories.

中文

产品与江苏麦得科生物科技有限公司生产的特异性生长因子检测试剂盒(化学法)配套使用。用于临床实验室室内质量控制。

Structure and composition
English

Level 1: pH of phosphate buffer = 6.8, 20mmol/L; Specific growth factor (SGF equivalent) (derived from E. coli), 50~200U/mL; Sodium chloride (NaCl), 0.15mol/L; ProClin-300,0.03%. Level 2: pH = 6.8, 20mmol/L; Specific growth factor (SGF equivalent) (derived from E. coli), 200~320U/mL; Sodium chloride (NaCl), 0.15mol/L; ProClin-300,0.03%.

中文

水平1:磷酸盐缓冲液pH=6.8,20mmol/L;特异性生长因子(SGF当量)(来源于大肠杆菌),50~200U/mL;氯化钠(NaCl),0.15mol/L;ProClin-300,0.03%。水平2:磷酸盐缓冲液pH=6.8,20mmol/L;特异性生长因子(SGF当量)(来源于大肠杆菌),200~320U/mL;氯化钠(NaCl),0.15mol/L;ProClin-300,0.03%。

Storage conditions and expiration
English

1.2~8 °C sealed storage, valid for 12 months. 2. After opening, store at 2~8 °C in the dark, which can be stable for 7 days.

中文

1.2~8℃密封储存,有效期为12个月。2.开瓶后,2~8℃避光储存,可稳定7天。

About this record

This static archive preserves historical registration fields and translations for Specific Growth Factor Quality Control Reagent, registration 苏械注准20212401563. 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.