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China NMPA legacy archive 苏械注准20232401635

Cortisol calibration solution

皮质醇校准品
Taizhou Zecen Biotech Co., Ltd.Class IINMPAApproved November 20, 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20232401635
Approval date
November 20, 2023
Expiry date
November 19, 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 epidermol detection kit (magnetic particle chemiluminescence method) project of 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。

Structure and composition
English

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.

中文

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。

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 Cortisol calibration solution, registration 苏械注准20232401635. 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.