Glycated hemoglobin analyzer - NMPA Registration 湘械注准20232221288
Access comprehensive regulatory information for Glycated hemoglobin analyzer 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20232221288 and owned by Hunan Yonghe-sun Biotechnology Co., Ltd.. The device was approved on December 27, 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 product is used with the eluent (high performance liquid chromatography) for glycosylated hemoglobin analysis produced by Hunan Yonghe Sunshine Biotechnology Co., Ltd. for the quantitative analysis of glycosylated hemoglobin in human whole blood samples.
本产品与湖南永和阳光生物科技股份有限公司生产的糖化血红蛋白分析用洗脱液（高效液相色谱法）配套使用，用于人体全血样本中糖化血红蛋白的定量分析。
The glycosylated hemoglobin analyzer adopts high-performance liquid chromatography, which is composed of a sampling module, a separation module, a detection module, a thermal printer, and software components. Injection module: It includes the sample feeding component, the sampling component and the tubing system, which realizes the transportation function of samples, reagents and waste liquid in the instrument, and is an important system to realize the function of the whole instrument. Separation module: Contains a column heater and a chromatography column, the column heater ensures that the elution process is completed under constant temperature conditions, avoiding the influence of ambient temperature on ion exchange. The column is packed with cation exchange resin, which separates HbA1c from the other components based on the affinity between the sample and the eluent and the column filler. Detection module: including light source and photodetector, detects the absorbance of hemoglobin components through ultraviolet light, measures the absorbance, and provides it to the software system for chromatographic analysis. Thermal printer: Prints chromatograms and test results. Software Components: Uses the area of each peak detected in the chromatogram, converts it to the concentration of each component, reports the HbA1c measurement as well as the chromatogram, and reports the glycosylated hemoglobin determination in % of NGSP units, as well as the mmol/mol results in IFCC units.
糖化血红蛋白分析仪采用高效液相色谱法,由进样模块、分离模块、检测模块、热敏打印机、软件组件组成。进样模块:包含送样部件、取样部件和管路系统,而管路系统实现样本、试剂和废液在仪器中的输送功能,是实现整台仪器功能的重要系统。分离模块:包含柱温箱和层析柱,柱温箱确保洗脱过程在恒温条件下完成,避免了环境温度对离子交换的影响。层析柱由阳离子交换树脂填充而成,根据样品与洗脱液以及层析柱填充剂三者之间亲和程度,从而将HbA1c与其它组分区分开而分离。检测模块:包括光源和光电检测器,通过紫外光检测血红蛋白组份的吸光度,测量吸光度,提供给软件系统进行色谱分析。热敏打印机:打印色谱图和检测结果。软件组件:利用检测到色谱的各峰面积,换算成各成分的浓度,其报告结果包含HbA1c测定值以及色谱图,并以NGSP单位的％报告糖化血红蛋白测定结果,同时报告IFCC单位的mmol/mol的结果。