Glycated Hemoglobin Assay Kit (Latex Immunoassay Method) - NMPA Registration 苏械注准20232400850
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 苏械注准20232400850 and owned by Ali Biotech Taizhou Co., Ltd.. The device was approved on June 15, 2023.
This page provides complete registration details including registrant information, province location (Jiangsu), 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 the proportion of glycated hemoglobin to total hemoglobin in human whole blood in vitro.
用于体外定量测定人全血中糖化血红蛋白占总血红蛋白的比例。
Reagent 1 (R1): latex 0.1%, glycine buffer 15mmol/L Reagent 2 (R2): sheep anti-murine immunoglobulin G antibody 0.08g/L, murine anti-human glycated hemoglobin monoclonal antibody 0.05g/L, glycine buffer 60mmol/L hemolysis: purified water, Proclin 300 0.1% calibrator (freezer): glycated hemoglobin (recombinant protein) Level 1: 4%~6% Level 2: 7%~9% Level 3: 10%~13% Level 4: 14%~18%, bovine serum albumin 1.0g/L, Proclin 300 0.1% quality control (frozen): glycated hemoglobin (recombinant protein) Level 1: 4%~8% Level 2: 9%~14%, bovine serum albumin 1.0g/L, Proclin 300 0.1%
试剂1（R1）：胶乳 0.1%、甘氨酸缓冲液 15mmol/L试剂2（R2）：羊抗鼠免疫球蛋白G抗体 0.08g/L、鼠抗人糖化血红蛋白单克隆抗体 0.05g/L 、甘氨酸缓冲液 60mmol/L溶血液：纯化水、Proclin 300 0.1%校准品（冷冻物）： 糖化血红蛋白（重组蛋白） 水平1：4%~6% 水平2：7%~9% 水平3：10%~13% 水平4：14%~18%、牛血清白蛋白 1.0g/L、Proclin 300 0.1%质控品（冷冻物）： 糖化血红蛋白（重组蛋白） 水平1：4%~8% 水平2：9%~14%、牛血清白蛋白 1.0g/L、Proclin 300 0.1%
1. The reagent is stored in 2 °C ~ 8 °C in the dark, the validity period is 18 months, and the reagent is stored in the dark at 2 °C ~ 8 °C after opening, and the validity period is 14 days. 2. Calibrators and quality control products are frozen at -20±2 °C, valid for 12 months, stored in the dark at 2 °C ~ 8 °C, valid for 30 days, and can be stable for 6 hours after remelting in the dark at 2 °C ~ 8 °C, and can be repeatedly frozen and thawed 3 times.
1.试剂在2℃~8℃避光保存，有效期18个月，试剂开瓶后在2℃～8℃避光保存，有效期14天。2.校准品、质控品在-20±2℃冷冻保存，有效期12个月，2℃~8℃避光保存，有效期30天，复融后在2℃~8℃避光保存可稳定6小时，可反复冻融3次。