Anti-insulin Antibody Calibration Material
- Device class
- Class II
- Model specifications
- 6×0.3mL;6×0. 5mL;6×1.0mL;6×2.0mL6×0.3mL；6×0. 5mL；6×1.0mL；6×2.0mL
- Approval department
- Jiangsu Provincial Drug Administration江苏省药品监督管理局
- Registration number
- 苏械注准20232401616
- Approval date
- November 17, 2023
- Expiry date
- November 16, 2028
- Name
- Taizhou Zecen Biotech Co., Ltd.泰州泽成生物技术有限公司
- Province/Region
- Jiangsu江苏
- 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
- 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 anti-insulin antibody detection kit (magnetic particle chemiluminescence method) project 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抗胰岛素抗体检测试剂盒（磁微粒化学发光法）项目测定时的系统校准。
The calibrator is mainly composed of human-derived anti-insulin antibodies and contains the stabilizer BSA. Calibrator C0: Tris buffer containing approximately 6% BSA, 0.05% Proclin300 (50 mmol/L pH: 7.5±0.1) at a concentration of 0 U/mL for anti-insulin antibodies; Calibrator C1: Tris buffer containing approximately 6% BSA, 0.05% Proclin300 (50 mmol/L pH: 7.5±0.1) at an anti-insulin antibody concentration of approximately 6.0 U/mL; Calibrator C2: Tris buffer containing approximately 6% BSA, 0.05% Proclin300 (50 mmol/L pH: 7.5±0.1) at an anti-insulin antibody concentration of approximately 12.5 U/mL; Calibrator C3: Tris buffer containing approximately 6% BSA, 0.05% Proclin300 (50 mmol/L pH: 7.5±0.1) at an anti-insulin antibody concentration of approximately 25 U/mL; Calibrator C4: Tris buffer containing approximately 6% BSA, 0.05% Proclin300 (50 mmol/L pH: 7.5±0.1) at a concentration of approximately 50 U/mL of anti-insulin antibody; Calibrator C5: Tris buffer containing approximately 6% BSA, 0.05% Proclin300 (50 mmol/L pH: 7.5±0.1) at an anti-insulin antibody concentration of approximately 100 U/mL.
校准品主要成分为人源的抗胰岛素抗体，并含有稳定剂BSA。 校准品C0:抗胰岛素抗体浓度为0U/mL的含约6%BSA，0.05%Proclin300的Tris缓冲液（50mmol/L pH：7.5±0.1）; 校准品C1:抗胰岛素抗体浓度约为6.0U/mL的含约6%BSA，0.05%Proclin300的Tris缓冲液（50mmol/L pH：7.5±0.1）; 校准品C2:抗胰岛素抗体浓度约为12.5U/mL的含约6%BSA，0.05%Proclin300的Tris缓冲液（50mmol/L pH：7.5±0.1）; 校准品C3:抗胰岛素抗体浓度约为25U/mL的含约6%BSA，0.05%Proclin300的Tris缓冲液（50mmol/L pH：7.5±0.1）; 校准品C4:抗胰岛素抗体浓度约为50U/mL的含约6%BSA，0.05%Proclin300的Tris缓冲液（50mmol/L pH：7.5±0.1）; 校准品C5:抗胰岛素抗体浓度约为100U/mL的含约6%BSA，0.05%Proclin300的Tris缓冲液（50mmol/L pH：7.5±0.1）。
1. Store at 2~8°C, before opening, it can be stored for 20 months. 2. It should be used within one month after opening, stored at 2~8 °C, and avoid direct sunlight.
1. 2~8℃保存，未开封前，可保存20个月。 2.开瓶后应在一个月内使用，2～8℃保存，避免阳光直射。
- Appendix
- 产品技术要求、说明书
Access comprehensive regulatory information for Anti-insulin Antibody 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20232401616 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.