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Thyroid-stimulating hormone receptor antibody (Anti-TSHR) assay kit (magnetic particle chemiluminescence method) - NMPA Registration 京械注准20242400009

Access comprehensive regulatory information for Thyroid-stimulating hormone receptor antibody (Anti-TSHR) assay kit (magnetic particle chemiluminescence method) in the China medical device market through Pure Global AI's free database. This Class II medical device is registered under NMPA registration number 京械注准20242400009 and owned by Beijing Savant Biotechnology Co., Ltd.. The device was approved on January 10, 2024.

This page provides complete registration details including registrant information, province location (Beijing), 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.

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Class II
京械注准20242400009
Thyroid-stimulating hormone receptor antibody (Anti-TSHR) assay kit (magnetic particle chemiluminescence method)
促甲状腺素受体抗体(Anti-TSHR)测定试剂盒（磁微粒化学发光法）
NMPA Registration Number: 京械注准20242400009
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Intended Use
English

This kit is used for the quantitative determination of the content of thyroid-stimulating hormone receptor antibody (Anti-TSHR) in human serum in vitro.

中文

本试剂盒用于体外定量测定人血清中促甲状腺素受体抗体（Anti-TSHR）的含量。

Device Classification
Device Class
Class II
Model Specifications
100 servings/box, 200 servings/box, 100 servings; 5/box.
100人份/盒、200人份/盒、100人份;5/盒。
Approval Department
Beijing Municipal Drug Administration
北京市药品监督管理局
Registration Information
Registration Number
京械注准20242400009
Approval Date
January 10, 2024
Expiry Date
January 09, 2029
Registrant
Name
Beijing Savant Biotechnology Co., Ltd.
北京华科泰生物技术股份有限公司
Province/Region
Beijing
北京
Address
101-301, 302, 3rd Floor, Building 4, No. 8 Liangshuihe 2nd Street, Beijing Economic and Technological Development Zone, Beijing (Yizhuang Group, High-end Industrial Area, Beijing Pilot Free Trade Zone)
北京市北京经济技术开发区凉水河二街8号院4号楼3层101-301、302（北京自贸试验区高端产业片区亦庄组团）
Production Facility
Production Address
北京市北京经济技术开发区凉水河二街8号院4号楼3层101-302
Structure and Composition
English

Calibrator (optional), quality control (optional), incubator, marker, magnetic particle reagent.

中文

校准品（选配）、质控品（选配）、温育液、标记物、磁微粒试剂。

Storage Conditions and Expiration
English

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Additional Information
Appendix
产品技术要求、说明书