China NMPA legacy archive 国械注准20243402389Alpha-fetoprotein (AFP) assay kit (magnetic chemiluminescence method)
- Device class
- Class III
- Model specifications
- 1×50 servings/box, 2×50 servings/box, 1×100 servings/box, 2×100 servings/box
- Approval department
- State Drug Administration
- Registration number
- 国械注准20243402389
- Approval date
- November 27, 2024
- Expiry date
- November 26, 2029
- Province/Region
- Shandong
- Address
- No. 1-4, Weigao Road, Torch High-tech Industrial Development Zone, Weihai City, Shandong Province
- Production address
- 山东省威海临港经济技术开发区棋山路566号
本产品用于体外定量检测人血清或血浆样本中的甲胎蛋白(AFP)的含量,主要用于对恶性肿瘤患者进行动态监测以辅助判断疾病进程或治疗效果,不能作为恶性肿瘤早期诊断或确诊的依据,不能用于普通人群的肿瘤筛查.
本产品用于体外定量检测人血清或血浆样本中的甲胎蛋白（AFP）的含量，主要用于对恶性肿瘤患者进行动态监测以辅助判断疾病进程或治疗效果，不能作为恶性肿瘤早期诊断或确诊的依据，不能用于普通人群的肿瘤筛查。
测甲胎蛋白磁微粒、测甲胎蛋白示踪结合物、分析缓冲液、校准品1、校准品2、样本稀释液、质控品.(具体内容详见产品说明书)
测甲胎蛋白磁微粒、测甲胎蛋白示踪结合物、分析缓冲液、校准品1、校准品2、样本稀释液、质控品。（具体内容详见产品说明书）
Store at 2~8°C, valid for 12 months.
2～8℃保存，有效期12个月。
- Appendix
- 产品技术要求、说明书
This static archive preserves historical registration fields and translations for Alpha-fetoprotein (AFP) assay kit (magnetic chemiluminescence method), registration 国械注准20243402389. It does not establish current authorization or complete current product details.
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