Insulin-like growth factor-I. calibrator - NMPA Registration 苏械注准20232401619
Access comprehensive regulatory information for Insulin-like growth factor-I. 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 苏械注准20232401619 and owned by Taizhou Zecen Biotech Co., Ltd.. The device was approved on November 17, 2023.
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.
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。