Specific growth factor determination reagent kit (chemical method)
- 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 number
- 沪械注准20242400177
- Approval date
- June 05, 2024
- Expiry date
- June 04, 2029
- 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 address
- 钦州北路1189号
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。
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。
2~8℃避光保存，有效期为18个月。
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.