Creatine Kinase Isoenzyme Determination Reagent Kit (Latex Immunoturbidimetry Method) - NMPA Registration 京械注准20232400720
Access comprehensive regulatory information for Creatine Kinase Isoenzyme Determination Reagent Kit (Latex Immunoturbidimetry Method) in the China medical device market through Pure Global AI's free database. This Class II medical device is registered under NMPA registration number 京械注准20232400720 and owned by Beijing Enjihe Biological Engineering Co., Ltd.. The device was approved on November 13, 2023.
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It is used for in vitro quantitative determination of creatine kinase isoenzyme (CK-MB) content in human serum or plasma.
用于体外定量测定人血清或血浆中肌酸激酶同工酶(CK-MB)的含量。
Reagent 1 4-Hydroxyethylpiperazine ethanesulfonic acid (HEPES) buffer 50mmol/L polyethylene glycol 0.3% sodium chloride 100mmol/L Bovine serum protein (BSA) 0.1% Reagent 2 Coated creatine kinase isoenzyme MB (CKMB) antibody to latex particles 0.2% Glycine buffer 50mmol/L Calibrators 4-Hydroxyethylpiperazine ethanesulfonic acid (HEPES) buffer 50mmol/L Creatine kinase isoenzyme MB (CKMB) antigen, level 6, lyophilized powder, buffer matrix, The target concentration range is: Level 1: 0 ng/mL Level 2: 5~15ng/mL Level 3: 20~40ng/mL Level 4: 40~80ng/mL Level 5: 80~120ng/mL Level 6: 160~240ng/mL Quality controls 4-Hydroxyethylpiperazine ethanesulfonic acid (HEPES) buffer 50mmol/L Creatine kinase isoenzyme MB (CKMB) antigen, level 2, lyophilized powder, buffer matrix, The target concentration range is: Level 1: 5~15ng/mL Level 2: 20~40ng/mL Note: The calibrators and controls are batch-specific, and the specific concentrations are shown in the target value sheet.
试剂1 4-羟乙基哌嗪乙磺酸 （HEPES）缓冲液 50mmol/L 聚乙二醇 0.3% 氯化钠 100mmol/L 牛血清蛋白（BSA） 0.1% 试剂2 包被肌酸激酶同工酶MB （CKMB）抗体的乳胶颗粒 0.2% 甘氨酸缓冲液 50mmol/L 校准品 4-羟乙基哌嗪乙磺酸 （HEPES）缓冲液 50mmol/L 肌酸激酶同工酶MB（CKMB） 抗原，6水平，冻干粉， 缓冲液基质， 目标浓度范围为 水平1：0ng/mL 水平2：5～15ng/mL 水平3：20～40ng/mL 水平4：40～80ng/mL 水平5：80～120ng/mL 水平6：160～240ng/mL 质控品 4-羟乙基哌嗪乙磺酸 （HEPES）缓冲液 50mmol/L 肌酸激酶同工酶MB（CKMB） 抗原，2水平，冻干粉， 缓冲液基质， 目标浓度范围为 水平1：5～15ng/mL 水平2：20～40ng/mL 注：校准品及质控品具有批特异性，具体浓度见靶值单。
Store at 2°C~8°C in the dark, expiration date 1
2℃～8℃避光保存，有效期1