China NMPA legacy archive 沪械注准20242400177Specific growth factor determination reagent kit (chemical method)
特异性生长因子测定试剂盒（化学法）
Shanghai Kehua Bio-Engineering Co., Ltd.Class IINMPAApproved June 05, 2024
Static archiveNMPA · legacy registration snapshot
Device classification
- Device class
- Class II
- Model specifications
- See annex.
- Approval department
- Shanghai Municipal Drug Administration
见附件。
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
- Province/Region
- Shanghai
- Address
- 1189 Qinzhou North Road, Xuhui District, Shanghai
上海
上海市徐汇区钦州北路1189号
Production facility
- Production address
- 钦州北路1189号
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。
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。
About this record
This static archive preserves historical registration fields and translations for Specific growth factor determination reagent kit (chemical method), registration 沪械注准20242400177. It does not establish current authorization or complete current product details.
The default China search uses the separately verified domestic-registration listing, checked daily. Its published listing fields and scope differ from this older snapshot.