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Type I Herpes Simplex Virus IgG Antibody Detection Test Kit (Chemiluminescence Method) - NMPA Registration 国械注准20253400079

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.

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Class III
国械注准20253400079
Type 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)
NMPA Registration Number: 国械注准20253400079
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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)。

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
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
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