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碘检测试剂盒(过氧乙酸四甲基联苯胺氧化显色法) - NMPA Registration 渝械注准20242400515

Access comprehensive regulatory information for 碘检测试剂盒(过氧乙酸四甲基联苯胺氧化显色法) 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20242400515 and owned by Chongqing Biostec Biological Technology Co., Ltd.. The device was approved on December 23, 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20242400515
碘检测试剂盒(过氧乙酸四甲基联苯胺氧化显色法)
碘检测试剂盒（过氧乙酸四甲基联苯胺氧化显色法）
NMPA Registration Number: 渝械注准20242400515
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Intended Use
English

本试剂盒用于体外定量检测人体尿液样本中碘的含量.临床上主要用于甲状腺疾病的辅助诊断.

中文

本试剂盒用于体外定量检测人体尿液样本中碘的含量。临床上主要用于甲状腺疾病的辅助诊断。

Device Classification
Device Class
Class II
Model Specifications
R1:20mL×1,R2:5mL×1;R1:32mL×1,R2:8mL×1;R1:48mL×1,R2:12mL×1;R1:20mL×2,R2:5mL×2;R1:32mL×2,R2:8mL×2;50T/盒;100T/盒;200T/盒;300T/盒;500T/盒. 校准品(选配)(3水平):3×0.5mL;3×1.0mL;3×2.0mL;3×5.0mL;3×10.0mL. 质控品(选配)(1水平):1×0.5mL;1×1.0mL;1×5.0mL.
R1：20mL×1，R2：5mL×1；R1：32mL×1，R2：8mL×1；R1：48mL×1，R2：12mL×1；R1：20mL×2，R2：5mL×2；R1：32mL×2，R2：8mL×2；50T/盒；100T/盒；200T/盒；300T/盒；500T/盒。 校准品（选配）（3水平）：3×0.5mL；3×1.0mL；3×2.0mL；3×5.0mL；3×10.0mL。 质控品（选配）（1水平）：1×0.5mL；1×1.0mL；1×5.0mL。
Approval Department
Chongqing Municipal Drug Administration
重庆市药品监督管理局
Registration Information
Registration Number
渝械注准20242400515
Approval Date
December 23, 2024
Expiry Date
December 22, 2029
Registrant
Name
Chongqing Biostec Biological Technology Co., Ltd.
重庆博士泰生物技术有限公司
Province/Region
Chongqing
重庆
Address
1st and 2nd floor, Building 2, No. 17, Camellia Road, Changshengqiao Town, Nan'an District, Chongqing
重庆市南岸区长生桥镇茶花路17号2幢1、2楼
Production Facility
Production Address
重庆市南岸区茶花路17号2幢1楼、2楼、3楼2-1、2-2
Structure and Composition
English

由试剂R1、试剂R2、校准品(选配)和质控品(选配)组成.(具体内容详见产品说明书)

中文

由试剂R1、试剂R2、校准品（选配）和质控品（选配）组成。（具体内容详见产品说明书）

Storage Conditions and Expiration
English

本品在2～8℃密闭、避光保存可稳定12个月,不得冻存;开瓶后试剂在2～8℃保存并应在14天内使用,开瓶后校准品和质控品应在2～8℃保存,并应在7天内使用.

中文

本品在2～8℃密闭、避光保存可稳定12个月，不得冻存；开瓶后试剂在2～8℃保存并应在14天内使用，开瓶后校准品和质控品应在2～8℃保存，并应在7天内使用。