单纯疱疹病毒1+2型IgM抗体检测试剂盒(化学发光免疫分析法) - NMPA Registration 国械注准20253400095
Access comprehensive regulatory information for 单纯疱疹病毒1+2型IgM抗体检测试剂盒(化学发光免疫分析法) 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20253400095 and owned by Shenzhen Mindray Bio-Medical Electronics 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.
本产品用于体外定性检测人血清或血浆中的单纯疱疹病毒1型和2型特异性IgM抗体。
磁珠包被物(Ra), 酶标记物(Rb), 样本处理液(Rc), 测试稀释液(Rd), 校准品C0, 校准品C1和条码。(具体内容详见产品说明书)
Store at 2~8°C, valid for 18 months.
2~8℃保存,有效期18个月。

