China NMPA legacy archive 国械注准20253400079Type I Herpes Simplex Virus IgG Antibody Detection Test Kit (Chemiluminescence Method)
单纯疱疹病毒Ⅰ型IgG抗体检测试剂盒（化学发光法）
Shenzhen Yhlo Biotech Co., Ltd.Class IIINMPAApproved January 10, 2025
Static archiveNMPA · legacy registration snapshot
Device classification
- Device class
- Class III
- Model specifications
- 1×50人份/盒、2×50人份/盒、2×150人份/盒。
- Approval department
- State Drug Administration
国家药品监督管理局
Registration information
- Registration number
- 国械注准20253400079
- Approval date
- January 10, 2025
- Expiry date
- January 09, 2030
Registrant
- Province/Region
- Guangdong
- Address
- Building 1, Yahuilong Biotechnology Factory, Baolong 2nd Road, Baolong Street, Longgang District, Shenzhen
广东
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
用于体外定性检测人血清和（或）血浆中的单纯疱疹病毒Ⅰ型IgG抗体（HSV-1 IgG）。
Structure and composition
English
本试剂由试剂1（R1）、试剂2（R2）、试剂3（R3）、校准品1（CAL1）和校准品2（CAL2）组成。（具体内容详见产品说明书）
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。
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 Type I Herpes Simplex Virus IgG Antibody Detection Test Kit (Chemiluminescence Method), registration 国械注准20253400079. 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.