Glutamate dehydrogenase assay kit (α-Ketoglutaric acid substrate 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1:60mL; 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; 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1:90mL; 6,试剂2:90mL; 2;试剂1:15mL; 1,试剂2:5mL; 1;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(冻干粉,选配):1mL; 1;2mL; 1;3mL; 1;5mL; 1;质控品(冻干粉,选配):1mL; 1;2mL; 1;3mL; 1;5mL; 1.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1：60mL;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;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1：90mL;6，试剂2：90mL;2；试剂1：15mL;1，试剂2：5mL;1；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（冻干粉，选配）：1mL;1；2mL;1；3mL;1；5mL;1；质控品（冻干粉，选配）：1mL;1；2mL;1；3mL;1；5mL;1。
- Approval department
- Beijing Municipal Drug Administration北京市药品监督管理局
- Registration number
- 京械注准20242400128
- Approval date
- March 22, 2024
- Expiry date
- March 21, 2029
- 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 glutamate dehydrogenase content in human serum and plasma.
用于体外定量测定人血清、血浆中谷氨酸脱氢酶的含量。
Reagent 1: Triethanolamine buffer 50mmol/L, pH 8.0, ammonium acetate 100mmol/L, ethylenediaminetetraacetic acid disodium (EDTA) 2.5mmol/Lalpha;-ketoglutarate 7mmol/L, Reagent 2: Triethanolamine buffer 50mmol/L, pH 8.0, adenosine 5'-diphosphate (ADP) 1.0mmol/L, reducing coenzyme (NADH) 0.2mmol/L, calibrator: PBS20mmol/ L, pH 7.4 glutamate dehydrogenase buffer matrix, single level, lyophilized powder, target concentration of 10~30U/L quality control PBS20mmol/L, pH 7.4 glutamate dehydrogenase buffer matrix, single level, lyophilized powder, target range of 5~40U/L Note: The calibrator and quality control are batch specific, and the specific concentration is shown in the target value list.
试剂1三乙醇胺缓冲液50mmol/L，pH8.0醋酸铵100mmol/L乙二胺四乙酸二钠（EDTA）2.5mmol/Lalpha;-酮戊二酸7mmol/L试剂2三乙醇胺缓冲液50mmol/L，pH8.0腺苷5`-二磷酸（ADP）1.0mmol/L还原性辅酶（NADH）0.2mmol/L校准品PBS20mmol/L，pH7.4谷氨酸脱氢酶缓冲液基质，单水平，冻干粉，目标浓度为10～30U/L质控品PBS20mmol/L，pH7.4谷氨酸脱氢酶缓冲液基质，单水平，冻干粉，靶值范围为5～40U/L注：校准品及质控品具有批特异性，具体浓度见靶值单。
2 °C ~ 8 °C storage, valid for 12 months.
2℃～8℃保存，有效期12个月。
Access comprehensive regulatory information for Glutamate dehydrogenase assay kit (α-Ketoglutaric acid substrate 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20242400128 and owned by Beijing Enjihe Biological Engineering Co., Ltd.. The device was approved on March 22, 2024.
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