China NMPA legacy archive 苏械注准20212401391Ammonia Assay Kit (Glutamate Dehydrogenase Method)
- Device class
- Class II
- Model specifications
- See Specifications/Model Accessories
- Approval department
- Jiangsu Provincial Drug Administration
- Registration number
- 苏械注准20212401391
- Approval date
- September 29, 2021
- Expiry date
- September 28, 2026
- Province/Region
- Jiangsu
- Address
- The third floor of the south building of Gaochuang Park, Shuyang County, Suqian City
- Production address
- 宿迁市沭阳县高创园南楼三层
It is used for the quantitative detection of ammonia (AMM) content in human plasma in vitro.
用于体外定量检测人血浆中氨（AMM)的含量。
Reagent 1: Tris(hydroxymethyl)aminomethane (Tris) buffer pH=7.5 100mmol/L glutamate dehydrogenase (GLDH) 10.0KU/LProclin-300 0.03% Tween 20 (Tween20) 0.5% Reagent 2: Tris(hydroxymethyl)aminomethane (Tris) buffer pH=7.5 100mmol/L adenosine diphosphate, disodium (ADP-Na) 2.0mmol/Lα-ketoglutaric acid 5.0mmol/L reduced nicotinamide adenine dinucleotide (NADH) 2.0mmol/LProclin-300 0.03% Tween 20 (Tween20) 0.5%
试剂1:三(羟甲基)氨基甲烷(Tris)缓冲液 pH=7.5 100mmol/L谷氨酸脱氢酶（GLDH） 10.0KU/LProclin-300 0.03%吐温20(Tween20) 0.5%试剂2:三(羟甲基)氨基甲烷(Tris)缓冲液 pH=7.5 100mmol/L二磷酸腺苷，二钠（ADP-Na） 2.0mmol/Lα-酮戊二酸 5.0mmol/L还原型烟酰胺腺嘌呤二核苷酸（NADH） 2.0mmol/LProclin-300 0.03%吐温20(Tween20) 0.5%
1. Sealed storage at 2°C~8°C, valid for 12 months. 2. 2°C~8°C open and stable for 28 days.
1. 2℃～8℃密封储存，有效期12个月。2. 2℃～8℃开瓶稳定28天。
This static archive preserves historical registration fields and translations for Ammonia Assay Kit (Glutamate Dehydrogenase Method), registration 苏械注准20212401391. It does not establish current authorization or complete current product details.
The default China search uses the separately verified domestic-registration listing, checked daily. Its published listing fields and scope differ from this older snapshot.