OIU
- 产品代码
- OIU
- 器械名称
- Test, Epithelial Ovarian Tumor Associated Antigen (He4)
- 管理类别
- 第 2 类（Class II）
- 21 CFR 条款
- 21 CFR 866.6010
- FDA 专业组
- Immunology
- 上市路径
- 需提交 510(k) 上市前通告
- 标记
- 可走第三方审查
- FDA 历史累计 510(k)
- 5 件（全部年份；本站只收录近三年的明细）
FDA 分类定义
An enzyme immunometric assay for the quantitative determination of HE4 in human serum. The assay is to be used as an aid in monitoring recurrence or progressive disease in patients with epithelial ovarian cancer. Serial testing for patient HE4 assay values should be used in conjunction with other clinical methods used for monitoring ovarian cancer. It is not intended to estimate or assess the risk of disease outcomes of patients.
FDA 官方分类页： OIU
分类与上市路径以 FDA 现行公告为准。本页数据来自 openFDA（CC0 公有领域），不构成注册策略建议。