Ammonia Assay Kit (Glutamate Dehydrogenase Method)
- Device class
- Class II
- Model specifications
- See Specifications/Model Accessories见规格/型号附件
- Approval department
- Jiangsu Provincial Drug Administration江苏省药品监督管理局
- Registration number
- 苏械注准20212401391
- Approval date
- September 29, 2021
- Expiry date
- September 28, 2026
- Name
- Jiangsu MDK BIOTECH Co., Ltd.江苏麦得科生物科技有限公司
- Province/Region
- Jiangsu江苏
- Address
- The third floor of the south building of Gaochuang Park, Shuyang County, Suqian City宿迁市沭阳县高创园南楼三层
- 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。
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 苏械注准20212401391 and owned by Jiangsu MDK BIOTECH Co., Ltd.. The device was approved on September 29, 2021.
This page provides complete registration details including registrant information, province location (Jiangsu), 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.