Trace albumin control material - NMPA Registration 闽械注准20242400135
Access comprehensive regulatory information for Trace albumin control material 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20242400135 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 our microalbumin kits for in-house quality control of microalbumin detection systems.
与本公司生产的微量白蛋白试剂盒配套使用，用于微量白蛋白检测系统的室内质量控制。.
This product is made with the addition of human-derived albumin, preservatives, etc. to a phosphate-buffered saline matrix. Albumin concentration range: level 1: 20mg/L~60mg/L; Level 2: 120mg/L~180mg/L.
本产品是在磷酸盐缓冲液基质中添加人源性的白蛋白、防腐剂等。白蛋白浓度范围：水平1：20mg/L～60mg/L；水平2：120mg/L～180mg/L.
The original packaging is stored in 2°C~8°C under the condition of closed and dark storage, and the validity period is 21 months.
原包装在2℃～8℃条件下密闭避光贮存，有效期21个月。