Specific Growth Factor Quality Control Reagent
- 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 number
- 苏械注准20212401563
- Approval date
- November 17, 2021
- Expiry date
- November 16, 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
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.
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。
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%.
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%。
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.
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。
Access comprehensive regulatory information for Specific Growth Factor Quality Control Reagent 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20212401563 and owned by Jiangsu MDK BIOTECH Co., Ltd.. The device was approved on November 17, 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.