甲型肝炎病毒IgM抗体检测试剂（免疫层析法）
- 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.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。
- Approval department
- State Drug Administration国家药品监督管理局
- Registration number
- 国械注准20253400092
- Approval date
- January 10, 2025
- Expiry date
- January 09, 2030
- Name
- Guangzhou Wondfo BIOTECH Co., Ltd.广州万孚生物技术股份有限公司
- Province/Region
- Guangdong广东
- Address
- No. 8, Lizhishan Road, Science City, Huangpu District, Guangzhou广州市黄埔区科学城荔枝山路8号
- Production address
- 广州市黄埔区科学城荔枝山路8号
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。
测试卡、样本稀释液（滴瓶）、吸管。（具体内容详见产品说明书）
Store at 2~30°C, valid for 24 months.
2～30℃保存，有效期24个月。
- Appendix
- 产品技术要求、说明书
Access comprehensive regulatory information for 甲型肝炎病毒IgM抗体检测试剂（免疫层析法） 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20253400092 and owned by Guangzhou Wondfo 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.