PAR

Test, Volatile Organic Compounds Breath Analysis

产品代码: PAR
器械名称: Test, Volatile Organic Compounds Breath Analysis
管理类别: 第 F 类（HDE）
FDA 专业组: Unknown
上市路径: HDE - Humanitarian Device Exemption

FDA 分类定义

Aid in the diagnosis of grade 3 heart transplant rejection in patients who have received heart transplants within the preceding year. Intended to be used as an adjunct to, and not as a substitute for, endomyocardial biopsy. The use of the device is limited to patients who have had endomyocardial biopsy within the previous month.

定义原文来自 FDA 器械分类库，属美国联邦政府作品（公有领域）。

FDA 官方分类页： PAR

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。