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China NMPA legacy archive 苏械注准20232401586

Type IV Collagen Calibration Product

Ⅳ型胶原校准品
Taizhou Zecen Biotech Co., Ltd.Class IINMPAApproved November 17, 2023
Static archiveNMPA · legacy registration snapshot
Device classification
Device class
Class II
Model specifications
6×0.3mL;6×0.5mL;6×1.0mL;6×2.0mL.
6×0.3mL;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 information
Registration number
苏械注准20232401586
Approval date
November 17, 2023
Expiry date
November 16, 2028
Registrant
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 facility
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
Intended use
English

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.

中文

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。

Structure and composition
English

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.

中文

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。

Storage conditions and expiration
English

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.

中文

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。

Additional information
Appendix
产品技术要求、说明书
About this record

This static archive preserves historical registration fields and translations for Type IV Collagen Calibration Product, registration 苏械注准20232401586. It does not establish current authorization or complete current product details.

The default China search uses the separately verified domestic-registration listing, checked daily. Its published listing fields and scope differ from this older snapshot.