糖化血红蛋白(HbA1c)测定试剂盒(乳胶凝集法) - NMPA Registration 粤械注准20242401299
Access comprehensive regulatory information for 糖化血红蛋白(HbA1c)测定试剂盒(乳胶凝集法) in the China medical device market through Pure Global AI's free database. This Class II medical device is registered under NMPA registration number 粤械注准20242401299 and owned by Genrui Biotech Inc.. The device was approved on September 27, 2024.
This page provides complete registration details including registrant information, province location (Guangdong), 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 to detect the content of glycated hemoglobin in human whole blood samples, and is mainly used clinically for the auxiliary diagnosis of diabetes and the monitoring of blood glucose levels.
用于检测人体全血样本中糖化血红蛋白的含量，临床上主要用于糖尿病的辅助诊断和血糖水平的监控。
1 buffer: 0.1% latex particles; 2 HbA1c sample diluent: purified water, preservative Proclin 300, 0.1%; 3. Antiserum: Tris buffer 25 mmol/L, sodium chloride 9g/L, mouse anti-human HbA1c monoclonal antibody, sheep anti-mouse IgG antibody; 4. Quality control (optional): lyophilized powder containing HbA1C; 5 Calibrator (optional): lyophilized powder containing HbA1C; 4. Magnetic card: polyvinyl chloride (PVC) plastic; 5. Stir bar (optional): stainless steel (for PA320); 6 test cups (optional) :(for PA320).
1缓冲液：0.1%乳胶颗粒； 2 HbA1c样本稀释液：纯化水，防腐剂Proclin 300，0.1%； 3抗血清：Tris缓冲液25 mmol/L，氯化钠9g/L，鼠抗人HbA1c单克隆抗体，羊抗鼠IgG抗体； 4.质控品(选配)：含HbA1C的冻干粉； 5 校准品(选配)：含HbA1C的冻干粉； 4磁卡：聚氯乙烯(PVC)塑料； 5搅拌子(选配)：不锈钢（适用于PA320）； 6测试杯(选配)：（适用于PA320）。
HbA1c sample diluents (not available for PA320), buffers, antiserum, calibrators, and controls are stored at 2-8°C for 12 months and cannot be frozen until the kit is opened. After opening the kit, HbA1c sample diluents (not available for PA320), buffers, and antiserum were stored at 2-8°C for 30 days, and calibrators and controls were reconstituted at 2-8°C for 7 days; When PA120 is turned on, the antiserum is in the machine (2-15°C), and the buffer and HbA1c sample diluent are in the machine (2-30°C) after the reagent is opened, and it can be stable for 7 days. When PA320 is turned on, the antiserum and buffer are in the machine (2-15°C) after the reagent is opened, and it can be stable for 7 days. When other applicable instruments are turned on, the buffer, antiserum, and HbA1C sample dilutions are in the machine (2-15°C) after the reagent is opened, and can be stable for 7 days.
试剂盒未开启前，HbA1c样本稀释液（不适用于PA320）、缓冲液、抗血清、校准品和质控品避光储存于2-8℃，可保存12个月，不可冷冻。 试剂盒开启后HbA1c样本稀释液（不适用于PA320）、缓冲液和抗血清保存于2-8℃，可稳定30天，校准品和质控品复溶后保存于2-8℃可稳定7天； PA120开机状态下，试剂开封后抗血清在机（2-15℃），缓冲液和HbA1c样本稀释液在机（2-30℃），可稳定7天。 PA320开机状态下，试剂开封后抗血清和缓冲液在机（2-15℃），可稳定7天。 其他适用仪器开机状态下，试剂开封后缓冲液、抗血清和HbA1C样本稀释液在机（2-15℃），可稳定7天。