Glycolipid Myocardial Enzyme Spectrum Test Kit (Microfluidic Biochemical Method) - NMPA Registration 苏械注准20232400133
Access comprehensive regulatory information for Glycolipid Myocardial Enzyme Spectrum Test Kit (Microfluidic Biochemical 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 苏械注准20232400133 and owned by Lansion Biotechnology Co., Ltd.. The device was approved on January 30, 2023.
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Used in conjunction with the dry biochemical analyzer produced by Nanjing Lanyu Biotechnology Co., Ltd., it is used for in vitro quantitative detection of creatine kinase isoenzymes, creatine kinase, α-hydroxybutyrate dehydrogenase, aspartate aminotransferase, lactate dehydrogenase, glucose, total cholesterol, triglycerides, uric acid concentration or activity in human whole blood, plasma and serum samples. Clinically, it is mainly used for the auxiliary diagnosis of glucose metabolism, lipid metabolism and cardiovascular-related diseases.
与南京岚煜生物科技有限公司生产的干式生化分析仪配套使用，用于体外定量检测人全血、血浆、血清样本中的肌酸激酶同工酶、肌酸激酶、α-羟丁酸脱氢酶、天门冬氨酸氨基转移酶、乳酸脱氢酶、葡萄糖、总胆固醇、甘油三酯、尿酸的浓度或活性。临床上主要用于糖代谢、脂代谢、心血管相关疾病的辅助诊断。
1. Glycolipid myocardial enzyme spectroscopy microfluidic reagent tray: 1 serving/dish The main components of the microfluidic reagent tray are as follows: Detection items Composition Glucose GLU lyophilized beads: potassium dihydrogen phosphate (22.4 g/L), 4-aminoantipyrine (0.08 g/L), ascorbate oxidase (1.6g/L), peroxidase (2.4 g/L), glucose oxidase (25.6 g/L), TOOS (0.1 g/L) Total cholesterol TC lyophilized beads: HEPES (6g/L) , EDTA-Na2 (0.6g/L), Triton X-114 (16g/L), 4-aminoantipyrine (0.16g/L), peroxidase (POD) (1.6g/L), cholesterol oxidase (COD) (0.5g/L), cholesterol esterase (CHE) (0.5g/L), TOOS (0.16g/L) Triglycerides TG lyophilized beads: Trimethylolaminomethane (Tris) (9.5 g/L), preservatives, Surfactant, 4-aminoantipyrine (0.096 g/L), sodium 2-hydroxy-3-m-toluidine propanesulfonate (TOOS) (0.1 g/L), adenine nucleoside triphosphate (ATP) (0.8 g/L), preservative, lipoprotein esterase (LPL) (6g/L), glycerophosphate oxidase (GPO) (5g/L), peroxidase (POD) (2g/L), glycerol kinase (GK) (0.25g/L) Uric acid UA lyophilized beads: dipotassium phosphate (28.6g/L), TOOS (0.16 g/L), EDTA-Na2 (0.15g/L), POD (3.2g/L), urcase (1.5g/L), 4-aminoantipyrine (0.08g/L) Lactate dehydrogenase LDH lyophilized beads: lithium lactate (4.8g/L), Tris (6.4g/L), Tris-HCl (2g/L), NAD (1.6g/L) α-hydroxybutyrate dehydrogenase α-HBDH lyophilized beads: Tris-HCl (13.32g/L), sodium α-ketobutyrate (0.744g/L), NADH (0.18g/L) Creatine kinase CK lyophilized beads: imidazole (4.8g/L), D-glucose (1.6g/L), ADP (1.2g/L), AMP (1.6g/L), EDTA-2Na (0.6g/L), N-acetylcysteine (1.2g/L), NAD+ (1.6g/L), Hexokinase (2.4g/L), glucose-6-phosphate dehydrogenase (1.92g/L), phosphocreatine (7g/L) Creatine kinase isoenzyme CK-MB lyophilized beads: imidazole (4.8g/L), D-glucose (1.6g/L), ADP (1.2g/L), AMP (1.6g/L), EDTA-2Na (0.6g/L), N-acetylcysteine (1.2g/L), NAD+ (1.6g/L), hexokinase (2.4g/ L), glucose-6-phosphate dehydrogenase (1.92g/L), anti-human CK-M antibody (1.2g/L), phosphocreatine (7g/L) aspartate aminotransferase AST lyophilized beads: L-aspartic acid (8.0g/L), reduced coenzyme I (NADH) (0.24g/L), trimethylolaminomethane (Tris) (6.0g/L), sodium α-ketoglutarate (2.4g/L), lactate dehydrogenase (0.04g/L), malate dehydrogenase ( 0.01g/L) 2. Instruction manual, calibration curve (QR code).
1.糖脂心肌酶谱微流控试剂盘：1人份/盘 微流控试剂盘的主要组成成分如下： 检测项目 组成成分 葡萄糖 GLU冻干珠：磷酸二氢钾(22.4 g/L)、4-氨基安替比林（0.08 g/L）、抗坏血酸氧化酶（1.6g/L）、过氧化物酶（2.4 g/L）、葡萄糖氧化酶（25.6 g/L）、TOOS（0.1 g/L） 总胆固醇 TC冻干珠：HEPES(6g/L)、EDTA-Na2(0.6g/L)、Triton X-114(16g/L)、4-氨基安替比林(0.16g/L)、过氧化物酶(POD)(1.6g/L)、胆固醇氧化酶(COD)(0.5g/L)、胆固醇酯酶(CHE)(0.5g/L)、TOOS(0.16g/L) 甘油三酯 TG冻干珠：三羟甲基氨基甲烷(Tris)(9.5 g/L)、防腐剂、表面活性剂、4-氨基安替比林(0.096g/L)、2-羟基-3-间甲苯胺丙磺酸钠(TOOS)(0.1 g/L)、腺嘌呤核苷三磷酸(ATP)(0.8 g/L)、防腐剂、脂蛋白酯酶(LPL)（6g/L）、甘油磷酸氧化酶(GPO)（5g/L）、过氧化物酶(POD)（2g/L）、甘油激酶(GK)（0.25g/L） 尿酸 UA冻干珠：磷酸氢二钾 （28.6g/L）、TOOS（0.16 g/L）、EDTA-Na2（ 0.15g/L）、POD （3.2g/L）、尿酸酶（ 1.5g/L）、4-氨基安替比林 （0.08g/L） 乳酸脱氢酶 LDH冻干珠：乳酸锂（4.8g/L）、Tris（6.4g/L）、Tris-HCl（2g/L）、NAD（1.6g/L） α-羟丁酸脱氢酶 α-HBDH冻干珠：Tris-HCl（13.32g/L）、α-酮丁酸钠（0.744g/L）、NADH（0.18g/L） 肌酸激酶 CK冻干珠：咪唑（4.8g/L）、D-葡萄糖（1.6g/L）、ADP（1.2g/L）、AMP（1.6g/L）、EDTA-2Na（0.6g/L）、N-乙酰半胱氨酸（1.2g/L）、NAD+（1.6g/L）、己糖激酶（2.4g/L）、葡萄糖-6-磷酸脱氢酶（1.92g/L）、磷酸肌酸（7g/L） 肌酸激酶同工酶 CK-MB冻干珠：咪唑（4.8g/L）、D-葡萄糖（1.6g/L）、ADP（1.2g/L）、AMP（1.6g/L）、EDTA-2Na（0.6g/L）、N-乙酰半胱氨酸（1.2g/L）、NAD+（1.6g/L）、己糖激酶（2.4g/L）、葡萄糖-6-磷酸脱氢酶（1.92g/L）、抗人CK-M抗体（1.2g/L）、磷酸肌酸（7g/L） 天门冬氨酸氨基转移酶 AST冻干珠：L-天冬氨酸(8.0g/L)、还原型辅酶I（NADH）(0.24g/L)、三羟甲基氨基甲烷 （Tris）(6.0g/L)、α-酮戊二酸钠(2.4g/L)、乳酸脱氢酶(0.04g/L)、苹果酸脱氢酶(0.01g/L) 2. 说明书、校准曲线（二维码）。
The kit is stable for 12 months when stored at 2-8 °C in the dark. Avoid direct sunlight. Remove the reagent tray from the refrigerator before using the kit, and put the remaining reagent tray back into the refrigerator in time. After opening the foil bag, it can be stable for 30 minutes at room temperature (10°C-30°C).
试剂盒在2-8℃避光保存可稳定12个月。避免阳光直射。使用试剂盒前从冰箱中取出试剂盘，剰余的试剂盘及时放回冰箱中。打开铝箔袋后，在常温（10℃-30℃）下可稳定30分钟。