Eluent for glycated hemoglobin analysis (high performance liquid chromatography) - NMPA Registration 湘械注准20232401047
Access comprehensive regulatory information for Eluent for glycated hemoglobin analysis (high performance liquid chromatography) 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20232401047 and owned by Hunan Yonghe-sun Biotechnology Co., Ltd.. The device was approved on November 03, 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.
It is used in conjunction with the glycosylated hemoglobin analysis system of Hunan Yonghe Sunshine Biotechnology Co., Ltd. for the quantitative detection of glycosylated hemoglobin (HbAlc) content in human whole blood samples in vitro.
与湖南永和阳光生物科技股份有限公司的糖化血红蛋白分析系统配套使用,用于体外定量检测人全血样本中糖化血红蛋白(HbAlc)的含量。
This product is an organic acid buffer system with different salt concentrations, and the main components include hemolytic agent H, eluent A, eluent B, eluent C, calibrator, quality control and consumables. Hemolytic agent H: ethylenediaminetetraacetic acid about 0.05g/L, surfactant about 1mL/L, sodium azide (NaN3) about 0.5g/L, eluent A: organic acid buffer about 14~20mmol/L, sodium azide (NaN3) about 0.2g/L, eluent B: organic acid buffer about 18~30mmol/L, sodium azide (NaN3) about 0.2g/L, eluent C: organic acid buffer about 25~40mmol/L, sodium azide (NaN3) Approx. 0.2g/L; calibrator: fresh whole blood about 90%, stabilizer about 10%, preservative about 0.02%, glycosylated hemoglobin concentration range: level 1 (4%-6%), level 1 (9%-11%); Quality controls: fresh whole blood about 90%, stabilizers about 10%, preservatives about 0.02%, glycosylated hemoglobin concentration range: level 1 (4%-6%), level 1 (9%-11%); Consumables: thermal printing paper (4 rolls), filter (1).
本产品为不同盐浓度的有机酸缓冲体系,主要组成成分包括溶血剂H、洗脱液A、洗脱液B、洗脱液C、校准品、质控品及耗材组分。溶血剂H:乙二胺四乙酸约0.05g/L、表面活性剂约1mL/L、叠氮钠(NaN3)约0.5g/L;洗脱液A:有机酸缓冲液约14～20mmol/L、叠氮钠(NaN3)约0.2g/L;洗脱液B:有机酸缓冲液约18～30mmol/L、叠氮钠(NaN3)约0.2g/L;洗脱液C:有机酸缓冲液约25～40mmol/L、叠氮钠(NaN3)约0.2g/L;校准品:新鲜全血约90％、稳定剂约10％、防腐剂约0.02％,糖化血红蛋白浓度范围:水平1(4％-6％)、水平1(9％-11％);质控品:新鲜全血约90％、稳定剂约10％、防腐剂约0.02％,糖化血红蛋白浓度范围:水平1(4％-6％)、水平1(9％-11％);耗材组分:热敏打印纸(4卷)、过滤片(1个)。
The unopened reagent is stored at 4~30°C and has a validity period of 12 months, and the reagent is stored at 4~30°C after opening and can be stable for 3 months. The unopened calibrator can be stored for 12 months at 2~8°C, the calibrator should be used within 24h after reconstitution, the unopened control can be stored for 12 months at 2~8°C, and the control can be stored at 2~8°C for 7 days after reconstitution.
未开封试剂在4～30℃条件下保存，有效期为12个月；开封后试剂在4～30℃条件下保存，可稳定3个月。未开封校准品2～8℃条件下，可保存12个月；校准品复溶后请在24h内使用完；未开封质控品2～8℃条件下，可保存12个月；质控品复溶后，2～8℃条件下保存，可稳定7天。