Pure Global AI
China NMPA legacy archive 粤械注准20252400135

Renin test kit (chemiluminescence method)

肾素测定试剂盒(化学发光法)
Shenzhen Yhlo Biotech Co., Ltd.Class IINMPAApproved January 22, 2025
Static archiveNMPA · legacy registration snapshot
Device classification
Device class
Class II
Model specifications
1×50人份/盒、2×50人份/盒.
1×50人份/盒、2×50人份/盒。
Approval department
Guangdong Provincial Drug Administration
广东省药品监督管理局
Registration information
Registration number
粤械注准20252400135
Approval date
January 22, 2025
Expiry date
January 21, 2030
Registrant
Name
Shenzhen Yhlo Biotech Co., Ltd.
深圳市亚辉龙生物科技股份有限公司
Province/Region
Guangdong
广东
Address
Building 1, Yahuilong Biotechnology Factory, Baolong 2nd Road, Baolong Street, Longgang District, Shenzhen
深圳市龙岗区宝龙街道宝龙二路亚辉龙生物科技厂区1栋
Production facility
Production address
深圳市龙岗区宝龙街道宝龙二路亚辉龙生物科技厂区2栋
Intended use
English

用于体外定量测定人血浆中的肾素(Renin)。临床上主要用于肾性高血压、内分泌型高血压的辅助诊断。

Structure and composition
English

由试剂1(R1)、试剂2(R2)、试剂3(R3)、校准品1(CAL1)、校准品2(CAL2)、校准品3(CAL3)组成。其中试剂1(R1):Renin抗体(哺乳动物细胞表达)的超顺磁性微粒,含防腐剂(ProClin 300);试剂2(R2):Renin抗体(哺乳动物细胞表达)吖啶标记结合物,含防腐剂(ProClin 300);试剂3(R3):样本处理液,为磷酸盐缓冲液,含防腐剂(ProClin 300);校准品1(CAL1):Tris缓冲液,含蛋白稳定剂、防腐剂(ProClin 300)的冻干品;校准品2(CAL2):Tris缓冲液,含重组肾素抗原(哺乳动物细胞表达)、蛋白稳定剂、防腐剂(ProClin 300)的冻干品;校准品3(CAL3):Tris缓冲液,含重组肾素抗原(哺乳动物细胞表达)、蛋白稳定剂、防腐剂(ProClin 300)的冻干品。

Storage conditions and expiration
English

试剂及校准品未开封竖直存放于2~8℃:可稳定18个月。试剂首次使用后存放于2~8℃:可稳定28天。试剂首次使用后2~8℃在机存放:可稳定28天。校准品复溶后,在2~8℃冷藏下,可稳定7天;在室温(20~25℃)下,可稳定8小时;在-20℃及以下保存可稳定56天;冻融次数不得超过2次。

Additional information
Appendix
产品技术要求、说明书
About this record

This static archive preserves historical registration fields and translations for Renin test kit (chemiluminescence method), registration 粤械注准20252400135. 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.