Glycosylated hemoglobin (HbA1c) calibrator - NMPA Registration 闽械注准20242400136
Access comprehensive regulatory information for Glycosylated hemoglobin (HbA1c) calibrator in the China medical device market through Pure Global AI's free database. This Class II medical device is registered under NMPA registration number 闽械注准20242400136 and owned by InTec Products, INC.. The device was approved on August 06, 2024.
This page provides complete registration details including registrant information, province location (Fujian), 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 kit manufactured by our company to establish the calibration curve of the glycosylated hemoglobin detection system.
与本公司生产的糖化血红蛋白试剂盒配套使用，用于建立糖化血红蛋白检测系统的校准曲线。.
This product is a lyophilized powder made by adding hemoglobin, glycosylated hemoglobin, preservatives, etc. to a phosphate buffered saline matrix. Glycosylated hemoglobin concentration range: Level 1: 0.0%; Level 2: 2.0%~6.0%; Level 3: 6.0%~9.0%; Level 4: 9.0%~12.0%; Level 5: 12.0%~15.0%.
本产品是在磷酸盐缓冲液基质中添加血红蛋白、糖化血红蛋白、防腐剂等制成的冻干粉。 糖化血红蛋白浓度范围： 水平1：0.0%； 水平2：2.0%～6.0%； 水平3：6.0%～9.0%； 水平4：9.0%～12.0%； 水平5：12.0%～15.0%。.
The original packaging is stored at 2°C~8°C in the dark, and the validity period is 18 months.
原包装避光贮存于2℃～8℃，有效期18个月。