Total Thyroxine Calibration Product - NMPA Registration 苏械注准20232401626
Access comprehensive regulatory information for Total Thyroxine Calibration Product 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20232401626 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 total thyroxine 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总甲状腺素检测试剂盒（磁微粒化学发光法）项目测定时的系统校准。
The calibrator is mainly composed of thyroxine and contains a stabilizer. Calibrator C0: Bovine serum matrix solution containing approximately 0.05% Proclin300 at a total thyroxine concentration of 0 nmol/L; Calibrator C1: Bovine serum matrix solution containing approximately 0.05% Proclin300 at a total thyroxine concentration of approximately 12 nmol/L (or 9.3 ng/mL); Calibrator C2: Bovine serum matrix solution containing approximately 0.05% Proclin300 at a total thyroxine concentration of approximately 58 nmol/L (or 45 ng/mL); Calibrator C3: Bovine serum matrix solution containing approximately 0.05% Proclin300 at a total thyroxine concentration of approximately 145 nmol/L (or 112 ng/mL); Calibrator C4: Bovine serum matrix solution containing approximately 0.05% Proclin300 at a total thyroxine concentration of approximately 258 nmol/L (or 200 ng/mL); Calibrator C5: Bovine serum matrix solution containing approximately 0.05% Proclin300 at a total thyroxine concentration of approximately 450 nmol/L (or 350 ng/mL). Note: Components are not interchangeable in different lot kits. Unit conversion: 1ng/mL=1.29nmol/L
校准品主要成分为甲状腺素，并含有稳定剂。校准品C0:总甲状腺素浓度为0nmol/L的含约0.05%Proclin300的牛血清基质溶液;校准品C1:总甲状腺素浓度约为12nmol/L（或9.3ng/mL）的含约0.05%Proclin300的牛血清基质溶液;校准品C2:总甲状腺素浓度约为58nmol/L（或45ng/mL）的含约0.05%Proclin300的牛血清基质溶液;校准品C3:总甲状腺素浓度约为145nmol/L（或112ng/mL）的含约0.05%Proclin300的牛血清基质溶液;校准品C4:总甲状腺素浓度约为258nmol/L（或200ng/mL）的含约0.05%Proclin300的牛血清基质溶液;校准品C5:总甲状腺素浓度约为450nmol/L（或350ng/mL）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。 单位换算：1ng/mL=1.29nmol/L
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。