Type I Herpes Simplex Virus IgG Antibody Detection Test Kit (Chemiluminescence Method)
- 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 number
- 国械注准20253400079
- Approval date
- January 10, 2025
- Expiry date
- January 09, 2030
- 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 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
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）。
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）
试剂及校准品未开封竖直存放于2～8℃：可稳定18个月。
- Appendix
- 产品技术要求、说明书
Access comprehensive regulatory information for Type I Herpes Simplex Virus IgG Antibody Detection Test Kit (Chemiluminescence Method) in the China medical device market through Pure Global AI's free database. This Class III medical device is registered under NMPA registration number 国械注准20253400079 and owned by Shenzhen Yhlo Biotech Co., Ltd.. The device was approved on January 10, 2025.
This page provides complete registration details including registrant information, province location (Guangdong), 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.