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Free Thyroxine Detection Reagent Kit (Dry Immuno-Fluorescence Method) - NMPA Registration 渝械注准20242400435

Access comprehensive regulatory information for Free Thyroxine Detection Reagent Kit (Dry Immuno-Fluorescence 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 渝械注准20242400435 and owned by Zybio Inc.. The device was approved on October 30, 2024.

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20242400435
Free Thyroxine Detection Reagent Kit (Dry Immuno-Fluorescence Method)
游离甲状腺素检测试剂盒(干式免疫荧光法)
NMPA Registration Number: 渝械注准20242400435
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Pricing
Intended Use
English

用于体外定量检测人体样本(血清、血浆或全血)中游离甲状腺素的含量.

中文

用于体外定量检测人体样本(血清、血浆或全血)中游离甲状腺素的含量。

Device Classification
Device Class
Class II
Model Specifications
1人份/盒、10人份/盒、25人份/盒、50人份/盒、100人份/盒、150人份/盒、200人份/盒
Approval Department
Chongqing Municipal Drug Administration
重庆市药品监督管理局
Registration Information
Registration Number
渝械注准20242400435
Approval Date
October 30, 2024
Expiry Date
October 29, 2029
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

本产品由试剂卡、样本稀释液、ID卡组成.其中ID卡为选配组分.(其他内容详见说明书)

中文

本产品由试剂卡、样本稀释液、ID卡组成。其中ID卡为选配组分。(其他内容详见说明书)

Storage Conditions and Expiration
English

1.试剂卡在铝箔袋密封的条件下,4~30℃干燥、避光环境储存,不得冻存,产品有效期为10个月.2.试剂卡开封后,在10~30℃环境下立即使用.

中文

1.试剂卡在铝箔袋密封的条件下,4~30℃干燥、避光环境储存,不得冻存,产品有效期为10个月。2.试剂卡开封后,在10~30℃环境下立即使用。

Additional Information
Changes
1.2024年10月30日首次注册; 2.2024年11月12日变更注册人住所。注册人住所变更:由“重庆市大渡口区建桥工业园C区太康路6号30栋第1-4层”变更为“重庆市大渡口区跳磴镇石林大道45号”。