C-reactive protein calibrator - NMPA Registration 闽械注准20242400108
Access comprehensive regulatory information for C-reactive protein 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20242400108 and owned by InTec Products, INC.. The device was approved on July 12, 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.
Used in conjunction with our full-scale C-reactive protein assay kits to establish calibration curves for C-reactive protein detection systems.
与本公司生产的全量程C反应蛋白测定试剂盒配套使用，用于建立C反应蛋白检测系统的校准曲线。.
This product is made with the addition of C-reactive protein, preservatives, etc. to a phosphate-buffered saline matrix. C-reactive protein concentration range: 0 point: 0mg/L (not included in 5 horizontal specifications); Level 1: 2mg/L~10mg/L; Level 2: 15mg/L~25mg/L; Level 3: 35mg/L~45mg/L; Level 4: 150mg/L~170mg/L; Level 5: 300mg/L~330mg/L.
本产品是在磷酸盐缓冲液基质中添加C反应蛋白、防腐剂等。 C反应蛋白浓度范围： 0点：0mg/L （5个水平规格不包含）； 水平1：2mg/L～10mg/L ； 水平2：15mg/L～25mg/L； 水平3：35mg/L～45mg/L； 水平4：150mg/L～170mg/L； 水平5：300mg/L～330mg/L。.
It is stored under the condition of 2°C~8°C and is stored in a closed and dark environment, with a validity period of 18 months.
2℃～8℃条件下密闭避光贮存，有效期18个月。