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China NMPA legacy archive 苏械注准20232401633

Glycocholic Acid Calibration Standard

甘胆酸校准品
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20232401633
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 glycolic acid detection kit (magnetic particle chemiluminescence method) 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甘胆酸检测试剂盒(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 synthetic antigens and contains the stabilizer bovine serum. Calibrator C0: Bovine serum matrix solution containing approximately 0.05% Proclin300 at a glycocholic acid concentration of 0 μg/mL; Calibrator C1: Bovine serum matrix solution containing approximately 0.05% Proclin300 at a glycocholic acid concentration of approximately 1.0 μg/mL; Calibrator C2: Bovine serum matrix solution containing approximately 0.05% Proclin300 at a glycocholic acid concentration of approximately 2.5 μg/mL; Calibrator C3: Bovine serum matrix solution containing approximately 0.05% Proclin300 at a glycocholic acid concentration of approximately 10.0 μg/mL; Calibrator C4: Bovine serum matrix solution containing approximately 0.05% Proclin300 at a concentration of approximately 20.0 μg/mL glycocholic acid; Calibrator C5: Bovine serum matrix solution containing approximately 0.05% Proclin300 at a glycocholic acid concentration of approximately 40.0 μg/mL.

中文

校准品主要成分为合成抗原,并含有稳定剂牛血清。 校准品C0:甘胆酸浓度为0μg/mL的含约0.05%Proclin300的牛血清基质溶液; 校准品C1:甘胆酸浓度约为1.0μg/mL的含约0.05%Proclin300的牛血清基质溶液; 校准品C2:甘胆酸浓度约为2.5μg/mL的含约0.05%Proclin300的牛血清基质溶液; 校准品C3:甘胆酸浓度约为10.0μg/mL的含约0.05%Proclin300的牛血清基质溶液; 校准品C4:甘胆酸浓度约为20.0μg/mL的含约0.05%Proclin300的牛血清基质溶液; 校准品C5:甘胆酸浓度约为40.0μg/mL的含约0.05%Proclin300的牛血清基质溶液。

Storage conditions and expiration
English

1. Store at 2~8°C, before opening, the product is valid for 20 months. 2. It should be used within one month after opening, stored at 2~8 °C, and avoid direct sunlight.

中文

1. 2~8℃保存,未开封前,产品有效期为20个月。 2.开瓶后应在一个月内使用,2~8℃保存,避免阳光直射。

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 Glycocholic Acid Calibration Standard, registration 苏械注准20232401633. 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.