China NMPA legacy archive 国械注准20253400092甲型肝炎病毒IgM抗体检测试剂（免疫层析法）
Guangzhou Wondfo BIOTECH Co., Ltd.Class IIINMPAApproved January 10, 2025
Static archiveNMPA · legacy registration snapshot
Device classification
- Device class
- Class III
- Model specifications
- Card type: foil bag single serving, 1 person/bag, 1 person/box, 10 people/box, 20 people/box, 25 people/box, 40 people/box, 50 people/box.
- Approval department
- State Drug Administration
卡型：铝箔袋单人份包装，1人份/袋、1人份/盒、10人份/盒、20人份/盒、25人份/盒、40人份/盒、50人份/盒。
国家药品监督管理局
Registration information
- Registration number
- 国械注准20253400092
- Approval date
- January 10, 2025
- Expiry date
- January 09, 2030
Registrant
- Province/Region
- Guangdong
- Address
- No. 8, Lizhishan Road, Science City, Huangpu District, Guangzhou
广东
广州市黄埔区科学城荔枝山路8号
Production facility
- Production address
- 广州市黄埔区科学城荔枝山路8号
Intended use
English
本试剂用于体外定性检测人血清或血浆中的甲型肝炎病毒IgM抗体。
Structure and composition
English
测试卡、样本稀释液（滴瓶）、吸管。（具体内容详见产品说明书）
Storage conditions and expiration
English
Store at 2~30°C, valid for 24 months.
中文
2～30℃保存，有效期24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 甲型肝炎病毒IgM抗体检测试剂（免疫层析法）, registration 国械注准20253400092. 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.