Aspartate aminotransferase mitochondrial isoenzyme assay kit (enzyme inhibition method)
- Device class
- Class II
- Model specifications
- Reagent 1:1; 40mL, reagent 2:1; 10mL; Reagent 1:2; 40mL, reagent 2:2; 10mL; Reagents 1:4; 40mL, reagent 2:4; 10mL; Reagent 1:1; 60mL, reagent 2:1; 15mL; Reagent 1:2; 60mL, reagent 2:2; 15mL; Reagents 1:4; 60mL, reagent 2:4; 15mL; Reagent 1:1; 20mL, reagent 2:1; 5mL; Reagent 1:2; 16mL, reagent 2:2; 4mL. Calibrator (optional): 1; 1mL. Quality control (optional): 1; 1mL.试剂1：1;40mL，试剂2：1;10mL； 试剂1：2;40mL，试剂2：2;10mL； 试剂1：4;40mL，试剂2：4;10mL； 试剂1：1;60mL，试剂2：1;15mL； 试剂1：2;60mL，试剂2：2;15mL； 试剂1：4;60mL，试剂2：4;15mL； 试剂1：1;20mL，试剂2：1;5mL； 试剂1：2;16mL，试剂2：2;4mL。 校准品（选配）：1;1mL。 质控品（选配）：1;1mL。
- Approval department
- Beijing Municipal Drug Administration北京市药品监督管理局
- Registration number
- 京械注准20232400558
- Approval date
- September 13, 2023
- Expiry date
- September 12, 2028
- Name
- Beijing SenMeiXiKeMa Biotechnology Co., Ltd.北京森美希克玛生物科技有限公司
- Province/Region
- Beijing北京
- Address
- 4th floor, Building 1, No. 85 Kechuang 6th Street, Beijing Economic and Technological Development Zone, Beijing (Yizhuang Group, High-end Industrial Area, Beijing Pilot Free Trade Zone)北京市北京经济技术开发区科创六街85号院1号楼4层（北京自贸试验区高端产业片区亦庄组团）
- Production address
- 北京市北京经济技术开发区科创六街85号院1号楼4层
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
- Appendix
- 产品技术要求、说明书
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.
This page provides complete registration details including registrant information, province location (Beijing), intended use, and regulatory compliance data from the official China NMPA medical device database. Pure Global AI offers free access to China's complete medical device registry, helping global MedTech companies navigate NMPA regulations efficiently.