Glycated Hemoglobin Assay Kit (Latex Immunoassay Method) - NMPA Registration 京械注准20212400527
Access comprehensive regulatory information for Glycated Hemoglobin Assay Kit (Latex Immunoassay 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 京械注准20212400527 and owned by Beijing Beijian Xinchuangyuan Biotechnology Co., Ltd.. The device was approved on October 18, 2021.
This page provides complete registration details including registrant information, province location (Beijing), 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 for the quantitative determination of glycated hemoglobin (HbA1c) as a percentage of total hemoglobin in human whole blood in vitro.
本产品用于体外定量测定人全血中糖化血红蛋白（HbA1c）占总血红蛋白的百分含量。
Reagent 1: Tris buffer ge; 30mmol/L latex microspheres ge; 1g/L Reagent 2: Tris buffer ge; 100mmol/L HbA1c monoclonal antibody ge; 50mg/L HbA1c polyantibody ge; 80mg/L Hemolytic agents: stabilizer GE; 1g/L Calibrator (optional) Level 1: Glycated hemoglobin 0.0% Level 2: Glycated hemoglobin (3.8~6.0)% Level 3: Glycated hemoglobin (6.0~9.0)% Level 4: Glycated hemoglobin (9.0~12.0)% Level 5: Glycated hemoglobin (12.0~16.0)% The calibrators are all whole blood matrix lyophilized Quality control (optional) Level 1: Glycated hemoglobin (3.0~6.0)% Level 2: Glycated hemoglobin (8.0~12.0)% The controls are all whole blood matrix lyophilized products There are batch-to-batch differences between calibrators and quality control products, and the specific concentrations are shown in the target value table.
试剂1： Tris缓冲液 ge;30mmol/L 胶乳微球 ge;1g/L 试剂2： Tris缓冲液 ge;100mmol/L HbA1c单抗 ge;50mg/L HbA1c多抗 ge;80mg/L 溶血剂： 稳定剂ge;1g/L 校准品（选配） 水平1：糖化血红蛋白 0.0% 水平2：糖化血红蛋白 (3.8～6.0)% 水平3：糖化血红蛋白 (6.0～9.0)% 水平4：糖化血红蛋白 (9.0～12.0)% 水平5：糖化血红蛋白 (12.0～16.0)% 该校准品均为全血基质冻干品 质控品（选配） 水平1：糖化血红蛋白 (3.0～6.0)% 水平2：糖化血红蛋白 (8.0～12.0)% 该质控品均为全血基质冻干品 校准品、质控品有批间差异，具体浓度见靶值表。
2 °C ~ 8 °C protected sealed storage, valid for 12 months.
2℃～8℃避光密封储存，有效期12个月。