ONX
- 产品代码
- ONX
- 器械名称
- Ovarian Adnexal Mass Assessment Score Test System
- 管理类别
- 第 2 类（Class II）
- 21 CFR 条款
- 21 CFR 866.6050
- FDA 专业组
- Obstetrics/Gynecology
- 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)
- 6 件（全部年份；本站只收录近三年的明细）
FDA 分类定义
An ovarian/adnexal mass assessment test is a devicem that measures one or more proteins in serum. It yields a single result for the likelihood that an adnexal pelvic mass in a woman, for whom surgery is planned, is malignant. The test isn for adjunctive use, in teh context of a negative primary clinical and radiological evaluation, to augmrent the identification of patienets whose gynecologic surgery requires oncology expertise and resources.
FDA 官方分类页： ONX
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。