Type IV Collagen Calibration Product - NMPA Registration 苏械注准20232401586
Access comprehensive regulatory information for Type IV Collagen 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20232401586 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 type IV collagen 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Ⅳ型胶原检测试剂盒（磁微粒化学发光法）项目测定时的系统校准。
The calibrator is mainly composed of type IV collagen and contains a stabilizer. Calibrator C0: Type IV collagen concentration of 0 ng/mL Tris buffer containing approximately 6% BSA, 0.05% Proclin300 (50 mmol/L pH: 7.5±0.1); Calibrator C1: Type IV collagen concentration is approximately 100 ng/mL Tris buffer containing approximately 6% BSA, 0.05% Proclin300 (50 mmol/L pH: 7.5±0.1); Calibrator C2:Type IV collagen concentration is approximately 250 ng/mL Tris buffer with approximately 6% BSA, 0.05% Proclin300 (50 mmol/L pH: 7.5±0.1); Calibrator C3:Type IV collagen concentration is approximately 450 ng/mL Tris buffer containing approximately 6% BSA, 0.05% Proclin300 (50 mmol/L pH: 7.5±0.1); Calibrator C4: Type IV collagen concentration of approximately 900 ng/mL Tris buffer containing approximately 6% BSA, 0.05% Proclin300 (50 mmol/L pH: 7.5±0.1); Calibrator C5:Type IV collagen concentration is approximately 2400 ng/mL Tris buffer containing approximately 6% BSA, 0.05% Proclin300 (50 mmol/L pH: 7.5±0.1). Note: Components are not interchangeable in different lot kits.
校准品主要成分为Ⅳ型胶原，并含有稳定剂。校准品C0:Ⅳ型胶原浓度为0ng/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:Ⅳ型胶原浓度约为100ng/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:Ⅳ型胶原浓度约为250ng/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:Ⅳ型胶原浓度约为450ng/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:Ⅳ型胶原浓度约为900ng/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:Ⅳ型胶原浓度约为2400ng/mL的含约6%BSA，0.05%Proclin300的Tris缓冲液（50mmol/L pH：7.5±0.1）。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。