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Thyroid Stimulating Hormone Control Material - NMPA Registration 渝械注准20252400057

Access comprehensive regulatory information for Thyroid Stimulating Hormone Control Material in the China medical device market through Pure Global AI's free database. This Class II medical device is registered under NMPA registration number 渝械注准20252400057 and owned by Zybio Inc.. The device was approved on January 26, 2025.

This page provides complete registration details including registrant information, province location (Chongqing), 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
渝械注准20252400057
Thyroid Stimulating Hormone Control Material
促甲状腺激素质控品
NMPA Registration Number: 渝械注准20252400057
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Intended Use
English

本产品配套中元汇吉生物技术股份有限公司生产的促甲状腺激素检测试剂盒(干式免疫荧光法)使用,用于促甲状腺激素(TSH)检测系统的质量控制。

Device Classification
Device Class
Class II
Model Specifications
2-level × 1 bottle × 0.5 mL, 2-level × 1 bottle × 1.0 mL
2水平×1瓶×0.5mL、2水平×1瓶×1.0mL
Approval Department
Chongqing Municipal Drug Administration
重庆市药品监督管理局
Registration Information
Registration Number
渝械注准20252400057
Approval Date
January 26, 2025
Expiry Date
January 25, 2030
Registrant
Name
Zybio Inc.
中元汇吉生物技术股份有限公司
Province/Region
Chongqing
重庆
Address
重庆市大渡口区跳磴镇石林大道45号
Production Facility
Production Address
重庆市大渡口区建桥工业园C区太康路10号27-28栋第1-4层
Structure and Composition
English

本产品为冻干质控品(具体内容详见产品说明书)。

Storage Conditions and Expiration
English

1. This product is sealed and stored at 2°C~8°C, and the validity period is 6 months. 2. This product can be stored at 2°C~8°C for 8 hours after reconstitution; It can be stored at -25°C~-15°C for 30 days, and the number of repeated freeze-thaw is not more than 3 times.

中文

1.本品2℃~8℃密封保存,有效期为6个月。2.本产品复溶后在2℃~8℃可保存8小时;在-25℃~-15℃可保存30天,反复冻融次数不大于3次。