Ammonia (AMM) Assay Kit (Glutamate Dehydrogenase Method) - NMPA Registration 湘械注准20232400818
Access comprehensive regulatory information for Ammonia (AMM) 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 湘械注准20232400818 and owned by Hunan Yonghe-sun Biotechnology Co., Ltd.. The device was approved on August 31, 2023.
This page provides complete registration details including registrant information, province location (Hunan), 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.
This kit is used for the quantitative determination of ammonia content in human serum or plasma in vitro, and is mainly used clinically for the auxiliary diagnosis of hepatic encephalopathy.
本试剂盒用于体外定量测定人血清或血浆中氨的含量,临床上主要用于肝性脑病的辅助诊断。
Reagent 1: Tris-HCl buffer 3g/L, ethylenediaminetetraacetic acid 1g/L, Tratonon X-100 0.2g/L, lactate dehydrogenase 40KU/L, Reagent 2: Tris-HCl buffer 6g/L, 2-oxoglutaric acid 2.95g/L, sucrose 60g/L, glutamate dehydrogenase 100KU/L, calibrator concentration range: level 1: (40-100) umol/L, Proclin300 1mL/L, ammonium chloride About 0-16mg/L; control concentration range: level 1: (20-100) umol/L, Proclin300 1mL/L, ammonium chloride about 8-14mg/L.
试剂1:Tris-HCl缓冲液 3g/L、乙二胺四乙酸 1g/L、曲拉通X-100 0.2g/L、 乳酸脱氢酶40KU/L;试剂2:Tris-HCl缓冲液 6g/L、2-氧代戊二酸 2.95g/L、 蔗糖 60g/L、谷氨酸脱氢酶 100KU/L;校准品浓度范围:水平1:(40-100)umol/L,Proclin300 1mL/L、氯化铵 约0-16mg/L;质控品浓度范围:水平1:(20-100)umol/L,Proclin300 1mL/L、氯化铵 约8-14mg/L。
The reagent is sealed and stored at 2 °C ~ 8 °C and protected from light, and the validity period is 12 months; the opened reagent should pay attention to avoid contamination, and the reagent 1a and reagent 1b are mixed in a ratio of 5:1 to form an application reagent 1, 2 °C ~ 8 °C can be stable for 28 days; the calibrator and quality control can be stable for 3 days at 2 °C-8 °C after opening.
试剂在2℃～8℃密封避光保存，有效期12个月；已开瓶试剂注意避免污染，试剂1a与试剂1b以5:1比例混合，形成应用试剂1，2℃～8℃可稳定28天；校准品、质控品开封后2℃-8℃可稳定3天。