Aspartate aminotransferase mitochondrial isoenzyme assay kit (enzyme inhibition method) - NMPA Registration 京械注准20232400558
Access comprehensive regulatory information for Aspartate aminotransferase mitochondrial isoenzyme assay kit (enzyme inhibition 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20232400558 and owned by Beijing SenMeiXiKeMa Biotechnology Co., Ltd.. The device was approved on September 13, 2023.
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For in vitro quantitative determination of the content of aspartate aminotransferase mitochondrial isoenzyme in human serum or plasma.
用于体外定量测定人血清或血浆中天门冬氨酸氨基转移酶线粒体同工酶的含量。
compose concentration Reagent 1 Tris buffer (pH 6.0~9.0) 100mmol/L L-aspartic acid 240mmol/L Malate dehydrogenase 500U/L lactate dehydrogenase 700U/L protease 20kU/L Reagent 2 Tris buffer (pH 6.0~9.0) 100mmol/L alpha;-ketoglutarate 12mmol/L NADH 0.23mmol/L calibrators, Lyophilized, 1 level (Optional) Tris buffer (pH 6.0~9.0) 20mmol/L Human serum 300mL/L m-AST target concentration range (15～30)U/L quality controls, Lyophilized, 1 level (Optional) Tris buffer (pH 6.0~9.0) 20mmol/L Human serum 300mL/L m-AST target concentration range (8～25)U/L The target value of the calibrator is batch-specific, see the target value list for details. The quality control quality control range is batch-specific, see the target value list for details.
组成 浓度 试剂1 Tris缓冲液(pH 6.0～9.0) 100mmol/L L-天门冬氨酸 240mmol/L 苹果酸脱氢酶 500U/L 乳酸脱氢酶 700U/L 蛋白酶 20kU/L 试剂2 Tris缓冲液(pH 6.0～9.0) 100mmol/L alpha;-酮戊二酸 12mmol/L NADH 0.23mmol/L 校准品， 冻干,1水平 （选配） Tris缓冲液(pH 6.0～9.0) 20mmol/L 人血清 300mL/L m-AST目标浓度范围 （15～30）U/L 质控品， 冻干,1水平 （选配） Tris缓冲液(pH 6.0～9.0) 20mmol/L 人血清 300mL/L m-AST目标浓度范围 （8～25）U/L 校准品靶值批特异，详见靶值单。质控品质控范围批特异，详见靶值单。
Store in the dark under the condition of 2 °C ~ 8 °C, there is
2℃～8℃条件下避光保存，有