Ammonia assay kit (glutamate dehydrogenase method)
- Device class
- Class II
- Model specifications
- (1) Reagent 1a: 42.5mL; 1. Reagent 1b: 8.5mL; 1. Reagent 2: 10mL; 1; (2) Reagent 1a: 42.5mL; 3. Reagent 1b: 8.5mL; 3. Reagent 2: 10mL; 3; (3) Reagent 1a: 50mL; 1. Reagent 1b: 10mL; 1. Reagent 2: 10mL; 1; (4) Reagent 1a: 50mL; 3. Reagent 1b: 10mL; 3. Reagent 2: 10mL; 3; (5) Reagent 1a: 15mL; 1. Reagent 1b: 3mL; 1. Reagent 2: 4mL; 1; (6) 700 tests/box; Calibrator: 1.0mL; 1 (optional); Control level 1: 1.0 mL; 1 (optional); Control level 2: 1.0 mL; 1 (optional).(1)试剂1a：42.5mL;1、试剂1b：8.5mL;1、试剂2：10mL;1； (2)试剂1a：42.5mL;3、试剂1b：8.5mL;3、试剂2：10mL;3； (3)试剂1a：50mL;1、试剂1b：10mL;1、试剂2：10mL;1； (4)试剂1a：50mL;3、试剂1b：10mL;3、试剂2：10mL;3； (5)试剂1a：15mL;1、试剂1b：3mL;1、试剂2：4mL;1； (6)700测试/盒； 校准品：1.0mL;1（选配）； 质控品水平1：1.0mL;1（选配）； 质控品水平2：1.0mL;1（选配）。
- Approval department
- Beijing Municipal Drug Administration北京市药品监督管理局
- Registration number
- 京械注准20232400575
- Approval date
- September 19, 2023
- Expiry date
- September 18, 2028
- Name
- Beijing WantaiDerui Diagnostic Technology Co., Ltd.北京万泰德瑞诊断技术有限公司
- Province/Region
- Beijing北京
- Address
- No. 31 Science Park Road, Changping District, Beijing北京市昌平区科学园路31号
- Production address
- 北京市昌平区科学园路31号1号楼1层102和106，1号楼3层A区、B区、C区，7号楼东侧303、西侧401
It is used for the quantitative determination of ammonia content in human serum in vitro.
用于体外定量测定人血清中氨的含量。
Reagent 1a: Tris buffer 49.5 mmoL/L Reagent 1b: reduced CoQ I disodium salt 1.25g/L alpha;-ketoglutarate disodium salt 19.8g/L REAGENT 2: GLUTAMATE DEHYDROGENASE (GLDH) 80.0KU/L Calibrator: ammonium chloride, target concentration range: 70.0~90.0mu; mol/L. Control: Ammonium chloride, target value range of QC: 1:25.0mu; mol/L～35.0mu; mol/L, level 2: 80.0mu; mol/L～100.0mu; mol/L. The calibrator and quality control product are batch specific, and the specific concentration is shown on the bottle label.
试剂1a：Tris缓冲液 49.5mmoL/L 试剂1b：还原型辅酶I二钠盐 1.25g/L alpha;-酮戊二酸二钠盐 19.8g/L 试剂2：谷氨酸脱氢酶（GLDH） 80.0KU/L 校准品：氯化铵，目标浓度范围：70.0~90.0mu;mol/L。 质控品：氯化铵，质控品靶值范围：水平1：25.0mu;mol/L～35.0mu;mol/L，水平2：80.0mu;mol/L～100.0mu;mol/L。 校准品、质控品批特异，具体浓度见瓶签。
- Appendix
- 产品技术要求、说明书
Access comprehensive regulatory information for Ammonia assay kit (glutamate dehydrogenase 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20232400575 and owned by Beijing WantaiDerui Diagnostic Technology Co., Ltd.. The device was approved on September 19, 2023.
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