Free Estradiol Calibration Standard - NMPA Registration 苏械注准20232401661
Access comprehensive regulatory information for Free Estradiol 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20232401661 and owned by Taizhou Zecen Biotech Co., Ltd.. The device was approved on November 22, 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 upstream ionoestriol 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游离雌三醇检测试剂盒（磁微粒化学发光法）项目测定时的系统校准。
The main component of the calibrator is estriol and contains the stabilizer bovine serum. Calibrator C0: Bovine serum matrix solution containing approximately 0.05% Proclin300 at a concentration of 0 ng/mL; Calibrator C1: bovine serum matrix solution containing approximately 0.05% Proclin300 at an estradiol concentration of approximately 0.1 ng/mL; Calibrator C2: bovine serum matrix solution containing approximately 0.05% Proclin300 at an estradiol concentration of approximately 0.3 ng/mL; Calibrator C3: Estradiol concentration of approximately 1.0 ng/ mL of bovine serum matrix solution containing approximately 0.05% Proclin300; Calibrator C4: bovine serum matrix solution containing approximately 0.05% Proclin300 at a concentration of approximately 3.0 ng/mL; Calibrator C5: Bovine serum matrix solution with approximately 0.05% Proclin300 at an estradiol concentration of approximately 6.9 ng/mL.
校准品主要成分为雌三醇，并含有稳定剂牛血清。 校准品C0：雌三醇浓度为0ng/mL的含约0.05%Proclin300的牛血清基质溶液； 校准品C1：雌三醇浓度约为0.1ng/mL的含约0.05%Proclin300的牛血清基质溶液； 校准品C2：雌三醇浓度约为0.3ng/mL的含约0.05%Proclin300的牛血清基质溶液； 校准品C3：雌三醇浓度约为1.0ng/mL的含约0.05%Proclin300的牛血清基质溶液； 校准品C4：雌三醇浓度约为3.0ng/mL的含约0.05%Proclin300的牛血清基质溶液； 校准品C5：雌三醇浓度约为6.9ng/mL的含约0.05%Proclin300的牛血清基质溶液。
1.2~8°C storage, before opening, the product validity period is 20 months. 2. After opening, it 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，未开封前，产品有效期为20个月。 2.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。