Complement C1q Calibration Material
- Device class
- Class II
- Model specifications
- 0.5mL/bottle× 5 bottles (5 levels)0.5mL/瓶×5瓶（5个水平）
- Approval department
- Jiangsu Provincial Drug Administration江苏省药品监督管理局
- Registration number
- 苏械注准20212401361
- Approval date
- September 26, 2021
- Expiry date
- September 25, 2026
- Name
- Jiangsu MDK BIOTECH Co., Ltd.江苏麦得科生物科技有限公司
- Province/Region
- Jiangsu江苏
- Address
- The third floor of the south building of Gaochuang Park, Shuyang County, Suqian City宿迁市沭阳县高创园南楼三层
- Production address
- 宿迁市沭阳县高创园南楼三层
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。
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.