Creatine kinase isoenzyme calibration solution
- Device class
- Class II
- Model specifications
- 1 mL/bottle × 5 bottles (lyophilized powder, 5 levels)1 mL/瓶×5瓶（冻干粉，5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20212401564
- 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
It is used in conjunction with the creatine kinase isoenzyme detection kit (latex immunoturbidimetric method) produced by Jiangsu Medeco Biotechnology Co., Ltd. for the calibration of clinical laboratory testing systems.
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，用于临床实验室检测系统的校准。
4-Hydroxyethylpiperazine ethanesulfonic acid (HEPES) buffer (pH=7.5), 50 mmol/L; Creatine kinase isoenzyme MB (CKMB) (derived from Pichia yeast), level 2:2~8ng/mL, level 3:19~31ng/mL, level 4:30~70 ng/mL, level 5:70~130 ng/mL, level 6:160~240 ng/mL; Sodium chloride (NaCl), 0.15mol/L; ProClin-300,0.03%.
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），水平2：2～8ng/mL、水平3：19～31ng/mL、水平4：30～70 ng/mL、水平5：70～130 ng/mL、水平6：160～240 ng/mL；氯化钠（NaCl），0.15mol/L；ProClin-300，0.03%。
1.2~8 °C sealed storage, valid for 12 months. 2. After reconstitution, seal storage at 2~8 °C and store 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，可保存7天。
Access comprehensive regulatory information for Creatine kinase isoenzyme 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20212401564 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.