Glycocholic Acid Calibration Standard
- 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20232401633
- Approval date
- November 20, 2023
- Expiry date
- November 19, 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 glycolic acid 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甘胆酸检测试剂盒（磁微粒化学发光法）项目测定时的系统校准。
The calibrator is mainly composed of synthetic antigens and contains the stabilizer bovine serum. Calibrator C0: Bovine serum matrix solution containing approximately 0.05% Proclin300 at a glycocholic acid concentration of 0 μg/mL; Calibrator C1: Bovine serum matrix solution containing approximately 0.05% Proclin300 at a glycocholic acid concentration of approximately 1.0 μg/mL; Calibrator C2: Bovine serum matrix solution containing approximately 0.05% Proclin300 at a glycocholic acid concentration of approximately 2.5 μg/mL; Calibrator C3: Bovine serum matrix solution containing approximately 0.05% Proclin300 at a glycocholic acid concentration of approximately 10.0 μg/mL; Calibrator C4: Bovine serum matrix solution containing approximately 0.05% Proclin300 at a concentration of approximately 20.0 μg/mL glycocholic acid; Calibrator C5: Bovine serum matrix solution containing approximately 0.05% Proclin300 at a glycocholic acid concentration of approximately 40.0 μg/mL.
校准品主要成分为合成抗原，并含有稳定剂牛血清。 校准品C0:甘胆酸浓度为0μg/mL的含约0.05%Proclin300的牛血清基质溶液; 校准品C1:甘胆酸浓度约为1.0μg/mL的含约0.05%Proclin300的牛血清基质溶液; 校准品C2:甘胆酸浓度约为2.5μg/mL的含约0.05%Proclin300的牛血清基质溶液; 校准品C3:甘胆酸浓度约为10.0μg/mL的含约0.05%Proclin300的牛血清基质溶液; 校准品C4:甘胆酸浓度约为20.0μg/mL的含约0.05%Proclin300的牛血清基质溶液; 校准品C5:甘胆酸浓度约为40.0μg/mL的含约0.05%Proclin300的牛血清基质溶液。
1. Store at 2~8°C, before opening, the product is valid 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，产品有效期为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 Glycocholic Acid Calibration Standard 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20232401633 and owned by Taizhou Zecen Biotech Co., Ltd.. The device was approved on November 20, 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.