Glycated Albumin Assay Kit (Enzyme Method) - NMPA Registration 冀械注准20142400348
Access comprehensive regulatory information for Glycated Albumin Assay Kit (Enzyme 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 冀械注准20142400348 and owned by Langfang Hengyi Biotechnology Co., Ltd.. The device was approved on November 07, 2019.
This page provides complete registration details including registrant information, province location (Hebei), 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.
It is used for the quantitative determination of glycated albumin (GA) concentration in human serum (pulp) in vitro.
用于体外定量测定人体血清（浆）中的糖化白蛋白（GA）浓度。
Reagent 1: 3-morpholino-2-hydroxypropanesulfonic acid (MOPSO) buffer, 100mmol/L; Glycated amino acid oxidase (KAOD), 12500U/L; 4-AMinoantipyrine, 10g/L; Albumin protease (TODB), 1500 U/L; Catalase, 5000U/L; Peroxidase, 1000 U/L. Reagent 2: MOPSO buffer, 100 mmol/L; Albuminase (TODB), 4500U/L; Peroxidase, 1000 U/L; N-ethyl-N-(2-hydroxy-3-sulfopropyl)-3-methylaniline sodium salt, 2.875 g/L. Calibrator: serum albumin. Control: serum albumin.
试剂1：3-吗啉-2-羟基丙磺酸（MOPSO）缓冲液,100mmol/L；糖化氨基酸氧化酶(KAOD),12500U/L；4-氨基安替比林，10g/L；白蛋白蛋白酶（TODB），1500U/L；过氧化氢酶，5000U/L；过氧化物酶，1000U/L。试剂2：MOPSO缓冲液，100mmol/L；白蛋白酶（TODB），4500U/L；过氧化物酶，1000U/L；N-乙基-N-(2-羟基-3-磺丙基)-3-甲基苯胺钠盐，2.875g/L。校准品：血清白蛋白。质控品：血清白蛋白。