Insulin-like growth factor-I. calibrator
- Device class
- Class II
- Model specifications
- 6×0.3 mL(冻干粉);6×0.5 mL(冻干粉); 6×1.0 mL(冻干粉);6×2.0 mL(冻干粉).
- Approval department
- Jiangsu Provincial Drug Administration
- Registration number
- 苏械注准20232401619
- Approval date
- November 17, 2023
- Expiry date
- November 16, 2028
- Province/Region
- Jiangsu
- Address
- Taizhou City, China Medicine City Kou Tai Road, east side of G59 Building No. 62 west half of the west side of the first to fourth floors
- Production address
- 泰州市中国医药城口泰路西侧、陆家路东侧G59幢62号西半侧一至四层
It is used for the system calibration of the insulin-like growth factor-I. detection kit (magnetic particle chemiluminescence method) on the supporting detection system of Taizhou Zecheng Biotechnology Co., Ltd.
用于泰州泽成生物技术有限公司配套检测系统上胰岛素样生长因子-Ⅰ检测试剂盒(磁微粒化学发光法)项目测定时的系统校准。
The main component of the calibrator is recombinant insulin-like growth factor-I. antigen, which is derived from E. coli and contains the stabilizer casein. Calibrator C0: Insulin-like growth factor-I. Tris buffer containing approximately 1% casein, 0.05% Tween, 4% trehalose, 0.05% Proclin300 (20 mmol/L pH: 7.2±0.1) at a concentration of approximately 40 ng/mL; Calibrator C1: Insulin-like Growth Factor-I. at a concentration of approximately 40 ng/mL containing approximately 1% casein, 0.05% Tween, 4% trehalose, 0.05% Tris buffer for Proclin300 (20 mmol/L pH: 7.2±0.1); Calibrator C2: Insulin-like Growth Factor-I. Tris buffer containing approximately 1% casein, 0.05% Tween, 4% trehalose, 0.05% Proclin300 at approximately 80 ng/mL (20 mmol/L pH: 7.2±0.1); Calibrator C3: Insulin-like Growth Factor-I. at approximately 1% concentration of approximately 240 ng/mL Casein, 0.05% Tween, 4% trehalose, 0.05% Proclin300 in Tris buffer (20 mmol/L pH: 7.2±0.1); Calibrator C4: Insulin-like Growth Factor-I. Tris buffer containing approximately 1% casein, 0.05% Tween, 4% trehalose, 0.05% Proclin300 (20 mmol/L pH: 7.2±0.1) at a concentration of approximately 640 ng/mL; Calibrator C5: Insulin-like growth factor-I. Tris buffer (20 mmol/L pH: 7.2±0.1) containing approximately 1% casein, 0.05% Tween, 4% trehalose, 0.05% Proclin300 at a concentration of approximately 1000 ng/mL.
校准品主要成分为重组胰岛素样生长因子-Ⅰ抗原,来源大肠杆菌,并含有稳定剂酪蛋白。 校准品C0:胰岛素样生长因子-Ⅰ浓度为0ng/mL的含约1%酪蛋白,0.05%吐温,4%海藻糖,0.05%Proclin300的Tris缓冲液(20mmol/L pH:7.2±0.1); 校准品C1:胰岛素样生长因子-Ⅰ浓度约为40ng/mL的含约1%酪蛋白,0.05%吐温,4%海藻糖,0.05%Proclin300的Tris缓冲液(20mmol/L pH:7.2±0.1); 校准品C2:胰岛素样生长因子-Ⅰ浓度约为80ng/mL的含约1%酪蛋白,0.05%吐温,4%海藻糖,0.05%Proclin300的Tris缓冲液(20mmol/L pH:7.2±0.1); 校准品C3:胰岛素样生长因子-Ⅰ浓度约为240ng/mL的含约1%酪蛋白,0.05%吐温,4%海藻糖,0.05%Proclin300的Tris缓冲液(20mmol/L pH:7.2±0.1); 校准品C4:胰岛素样生长因子-Ⅰ浓度约为640ng/mL的含约1%酪蛋白,0.05%吐温,4%海藻糖,0.05%Proclin300的Tris缓冲液(20mmol/L pH:7.2±0.1); 校准品C5:胰岛素样生长因子-Ⅰ浓度约为1000ng/mL的含约1%酪蛋白,0.05%吐温,4%海藻糖,0.05%Proclin300的Tris缓冲液(20mmol/L pH:7.2±0.1)。
1. This product is lyophilized, stored at 2~8 °C before opening, and can be stored for 24 months. 2. After reconstitution, it can be stored for 1 day at 2 °C ~ 8 °C, and 7 days at -20 °C to avoid direct sunlight. 3. The production date and expiration date are shown on the packaging label.
1.本品为冻干品,未开封前,2~8℃保存,可保存24个月。 2.复溶后2℃~8℃可保存1天,-20℃可保存7天,避免阳光直射。 3.生产日期和失效日期见包装标签。
- Appendix
- 产品技术要求、说明书
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