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Specific growth factor determination reagent kit (chemical method) - NMPA Registration 沪械注准20242400177

Access comprehensive regulatory information for Specific growth factor determination reagent kit (chemical 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 沪械注准20242400177 and owned by Shanghai Kehua Bio-Engineering Co., Ltd.. The device was approved on June 05, 2024.

This page provides complete registration details including registrant information, province location (Shanghai), 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
沪械注准20242400177
Specific growth factor determination reagent kit (chemical method)
特异性生长因子测定试剂盒(化学法)
NMPA Registration Number: 沪械注准20242400177
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Intended Use
English

本试剂盒供医疗机构用于体外定量测定人体血清中特异性生长因子的含量,作辅助诊断用。

Device Classification
Device Class
Class II
Model Specifications
See annex.
见附件。
Approval Department
Shanghai Municipal Drug Administration
上海市药品监督管理局
Registration Information
Registration Number
沪械注准20242400177
Approval Date
June 05, 2024
Expiry Date
June 04, 2029
Registrant
Name
Shanghai Kehua Bio-Engineering Co., Ltd.
上海科华生物工程股份有限公司
Province/Region
Shanghai
上海
Address
1189 Qinzhou North Road, Xuhui District, Shanghai
上海市徐汇区钦州北路1189号
Production Facility
Production Address
钦州北路1189号
Structure and Composition
English

试剂1(R1):Good’s缓冲液、4-二甲基氨基苯甲醛;试剂2(R2):柠檬酸缓冲液、茚三酮;校准品:正常人血清;质控品L、H:正常人血清。

Storage Conditions and Expiration
English

2~8℃避光保存,有效期为18个月。