Creatine kinase isoenzyme quality control product - NMPA Registration 苏械注准20212401559
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.
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。