Creatine kinase isoenzyme quality control product
- Device class
- Class II
- Model specifications
- 1mL/bottle × 2 bottles (lyophilized powder, 2 levels)1mL/瓶×2瓶（冻干粉，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20212401559
- 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 in conjunction with the creatine kinase isoenzyme detection kit (latex immunoturbidimetric method) produced by Jiangsu Medeco Biotechnology Co., Ltd. It is used for quality control in clinical laboratories to ensure the accuracy of testing.
产品与江苏麦得科生物科技有限公司生产的肌酸激酶同工酶检测试剂盒（胶乳免疫比浊法）配套使用。用于临床实验室室内质量控制，从而保证检测的准确性。
Level 1: 4-Hydroxyethylpiperazine ethanesulfonic acid (HEPES) buffer (pH=7.5), 50 mmol/L; Creatine kinase isoenzyme MB (CKMB) (derived from Pichia yeast) 2~8ng/mL; Sodium chloride (NaCl), 0.15mol/L; ProClin-300,0.03%. Level 2: 4-hydroxyethylpiperazine ethionate (HEPES) buffer (pH=7.5), 50 mmol/L; Creatine kinase isoenzyme MB (CKMB) (derived from Pichia yeast) 30~70ng/mL; Sodium chloride (NaCl), 0.15mol/L; ProClin-300,0.03%.
水平1：4-羟乙基哌嗪乙磺酸（HEPES）缓冲液（pH=7.5），50 mmol/L；肌酸激酶同工酶MB（CKMB）（来源于毕赤酵母）2～8ng/mL；氯化钠（NaCl），0.15mol/L；ProClin-300，0.03%。水平2：4-羟乙基哌嗪乙磺酸（HEPES）缓冲液（pH=7.5），50 mmol/L；肌酸激酶同工酶MB（CKMB）（来源于毕赤酵母）30～70ng/mL；氯化钠（NaCl），0.15mol/L；ProClin-300，0.03%。
1. Sealed storage at 2~8°C, valid for 12 months. 2. After reconstitution, sealed storage at 2~8 °C, it can be stable for 7 days.
1. 2～8℃密封储存，有效期为12个月。2. 复溶后2～8℃密封储存，可稳定7天。
Access comprehensive regulatory information for Creatine kinase isoenzyme quality control product 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20212401559 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.