Complement C1q Calibration Material - NMPA Registration 苏械注准20212401361
Access comprehensive regulatory information for Complement C1q Calibration 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 苏械注准20212401361 and owned by Jiangsu MDK BIOTECH Co., Ltd.. The device was approved on September 26, 2021.
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.
The product is used in conjunction with the complement C1q detection kit (immunoturbidimetric method) produced by Jiangsu Medeco Biotechnology Co., Ltd. For calibration of clinical laboratory testing systems.
产品与江苏麦得科生物科技有限公司生产的补体C1q检测试剂盒（免疫比浊法）配套使用。用于临床实验室检测系统的校准。
Complement C1q Level 1: 0mg/L Level 2: 60±12mg/L Level 3: 120±24mg/L Level 4: 240±48mg/L Level 5: 480±96mg/L phosphate buffer pH=7.0 0.05mol/L sodium chloride (NaCl) 0.15mol/LProClin-300 0.03% Tween-20 (Tween20) 0.5%
补体C1q 水平1： 0mg/L 水平2： 60±12mg/L 水平3： 120±24mg/L 水平4： 240±48mg/L 水平5： 480±96mg/L磷酸盐缓冲液pH=7.0 0.05mol/L氯化钠（NaCl） 0.15mol/LProClin-300 0.03%吐温-20（Tween20） 0.5%
1. Sealed storage at 2°C~8°C, valid for 12 months. 2. Open the bottle at 2°C~8°C and stabilize for 7 days.
1. 2℃～8℃密封储存，有效期12个月。2. 2℃～8℃开瓶稳定7天。