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China NMPA legacy archive 苏械注准20232401661

Free Estradiol Calibration Standard

游离雌三醇校准品
Taizhou Zecen Biotech Co., Ltd.Class IINMPAApproved November 22, 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20232401661
Approval date
November 22, 2023
Expiry date
November 21, 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 upstream ionoestriol 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。

Structure and composition
English

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.

中文

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。

Storage conditions and expiration
English

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.

中文

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。

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 Free Estradiol Calibration Standard, registration 苏械注准20232401661. 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.