China NMPA legacy archive 苏械注准20212401361Complement C1q Calibration Material
- Device class
- Class II
- Model specifications
- 0.5mL/bottle× 5 bottles (5 levels)
- Approval department
- Jiangsu Provincial Drug Administration
- Registration number
- 苏械注准20212401361
- Approval date
- September 26, 2021
- Expiry date
- September 25, 2026
- Province/Region
- Jiangsu
- Address
- The third floor of the south building of Gaochuang Park, Shuyang County, Suqian City
- 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。
This static archive preserves historical registration fields and translations for Complement C1q Calibration Material, registration 苏械注准20212401361. It does not establish current authorization or complete current product details.
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