Creatine kinase isoenzyme calibration solution - NMPA Registration 苏械注准20212401564
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.
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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。