Cortisol calibration solution - NMPA Registration 苏械注准20232401635
Access comprehensive regulatory information for Cortisol calibration solution 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20232401635 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.
It is used for the system calibration of the epidermol detection kit (magnetic particle chemiluminescence method) project of 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皮质醇检测试剂盒（磁微粒化学发光法）项目测定时的系统校准。
The calibrator is mainly composed of cortisol and contains a stabilizer. Calibrator C0: Bovine serum matrix solution containing approximately 0.05% Proclin300 at a cortisol concentration of 0 μg/dL; Calibrator C1: Bovine serum matrix solution containing approximately 0.05% Proclin300 at a cortisol concentration of approximately 2 μg/dL; Calibrator C2: Bovine serum matrix solution containing approximately 0.05% Proclin300 at a cortisol concentration of approximately 5 μg/dL; Calibrator C3: Bovine serum matrix solution containing approximately 0.05% Proclin300 at a cortisol concentration of approximately 10 μg/dL; Calibrator C4: Bovine serum matrix solution containing approximately 0.05% Proclin300 at a cortisol concentration of approximately 25 μg/dL; Calibrator C5: Bovine serum matrix solution containing approximately 0.05% Proclin300 at a cortisol concentration of approximately 60 μg/dL. Note: Components are not interchangeable in different lot kits.
校准品主要成分为皮质醇，并含有稳定剂。校准品C0:皮质醇浓度为0μg/dL的含约0.05%Proclin300的牛血清基质溶液;校准品C1:皮质醇浓度约为2μg/dL的含约0.05%Proclin300的牛血清基质溶液;校准品C2:皮质醇浓度约为5μg/dL的含约0.05%Proclin300的牛血清基质溶液;校准品C3:皮质醇浓度约为10μg/dL的含约0.05%Proclin300的牛血清基质溶液;校准品C4:皮质醇浓度约为25μg/dL的含约0.05%Proclin300的牛血清基质溶液;校准品C5:皮质醇浓度约为60μg/dL的含约0.05%Proclin300的牛血清基质溶液。注：不同批号试剂盒中各组分不可以互换。
1. Store at 2~8°C, the product validity period is 20 months. 2. After opening the bottle, the liquid reagent should be used within 1 month, stored at 2~8 °C, and avoid direct sunlight. 3. The production date and expiration date are shown in the packaging label.
1. 2～8℃保存，产品有效期为20个月。2.液体试剂开瓶后应在1个月内使用，2～8℃保存，避免阳光直射。3.生产日期和失效日期见包装标签。