Creatine Kinase Isoenzyme Determination Reagent Kit (Latex Immunoturbidimetry Method)
- Device class
- Class II
- Model specifications
- 试剂1:12mL; 1,试剂2:4mL; 1; 试剂1:12mL; 3,试剂2:4mL; 3; 试剂1:12mL; 4,试剂2:4mL; 4; 试剂1:12mL; 5,试剂2:4mL; 5; 试剂1:12mL; 6,试剂2:4mL; 6; 试剂1:12mL; 7,试剂2:4mL; 7; 试剂1:12mL; 8,试剂2:4mL; 8; 试剂1:12mL; 9,试剂2:4mL; 9; 试剂1:12mL; 10,试剂2:4mL; 10;试剂1:15mL; 1,试剂2:5mL; 1; 试剂1:60mL; 1,试剂2:20mL; 1; 试剂1:60mL; 2,试剂2:20mL; 2; 试剂1:60mL; 3,试剂2:20mL; 3; 试剂1:60mL; 3,试剂2:60mL; 1; 试剂1:60mL; 4,试剂2:20mL; 4; 试剂1: 60mL; 2,试剂2: 40mL; 1; 试剂1: 60mL; 4,试剂2: 40mL; 2; 试剂1: 60mL; 5,试剂2: 50mL; 2; 试剂1:60mL; 5,试剂2:20mL; 5; 试剂1: 60mL; 6,试剂2: 60mL; 2; 试剂1:60mL; 6,试剂2:20mL; 6; 试剂1:90mL; 6,试剂2:90mL; 2; 试剂1:90mL; 1,试剂2:30mL; 1; 试剂1:90mL; 2,试剂2:60mL; 1; 试剂1:90mL; 3,试剂2:90mL; 1; 试剂1:90mL; 4,试剂2:60mL; 2; 试剂1:3L; 1, 试剂2:1L; 1; 试剂1:15L; 1, 试剂2:5L; 1; 试剂1:45mL; 1,试剂2: 15mL; 1; 试剂1:45ml; 2.试剂2: 15ml; 2; 校准品(6水平,冻干粉,选配):1mL; 6;2mL; 6;3mL; 6; 质控品(2水平,冻干粉,选配):1mL; 2;2mL; 2;3mL; 2.试剂1:12mL;1,试剂2:4mL;1; 试剂1:12mL;3,试剂2:4mL;3; 试剂1:12mL;4,试剂2:4mL;4; 试剂1:12mL;5,试剂2:4mL;5; 试剂1:12mL;6,试剂2:4mL;6; 试剂1:12mL;7,试剂2:4mL;7; 试剂1:12mL;8,试剂2:4mL;8; 试剂1:12mL;9,试剂2:4mL;9; 试剂1:12mL;10,试剂2:4mL;10;试剂1:15mL;1,试剂2:5mL;1; 试剂1:60mL;1,试剂2:20mL;1; 试剂1:60mL;2,试剂2:20mL;2; 试剂1:60mL;3,试剂2:20mL;3; 试剂1:60mL;3,试剂2:60mL;1; 试剂1:60mL;4,试剂2:20mL;4; 试剂1: 60mL;2,试剂2: 40mL;1; 试剂1: 60mL;4,试剂2: 40mL;2; 试剂1: 60mL;5,试剂2: 50mL;2; 试剂1:60mL;5,试剂2:20mL;5; 试剂1: 60mL;6,试剂2: 60mL;2; 试剂1:60mL;6,试剂2:20mL;6; 试剂1:90mL;6,试剂2:90mL;2; 试剂1:90mL;1,试剂2:30mL;1; 试剂1:90mL;2,试剂2:60mL;1; 试剂1:90mL;3,试剂2:90mL;1; 试剂1:90mL;4,试剂2:60mL;2; 试剂1:3L;1, 试剂2:1L;1; 试剂1:15L;1, 试剂2:5L;1; 试剂1:45mL;1,试剂2: 15mL;1; 试剂1:45ml;2,试剂2: 15ml;2; 校准品(6水平,冻干粉,选配):1mL;6;2mL;6;3mL;6; 质控品(2水平,冻干粉,选配):1mL;2;2mL;2;3mL;2。
- Approval department
- Beijing Municipal Drug Administration北京市药品监督管理局
- Registration number
- 京械注准20232400720
- Approval date
- November 13, 2023
- Expiry date
- November 12, 2028
- Name
- Beijing Enjihe Biological Engineering Co., Ltd.乐普(北京)诊断技术股份有限公司
- Province/Region
- Beijing北京
- Address
- 205, Building 1, No. 6 Lixiang Road, Nanshao Town Science and Technology Park, Changping District, Beijing北京市昌平区南邵镇科技园区利祥路6号1幢205
- Production address
- 北京市平谷区马坊镇盘龙西路21号院3号楼二层
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
- Appendix
- 产品技术要求、说明书
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