PHK

Test, Cell Mediated Immune Response, Liver And Small Bowel Transplant/Transplantation

产品代码: PHK
器械名称: Test, Cell Mediated Immune Response, Liver And Small Bowel Transplant/Transplantation
管理类别: 第 N 类（Not Classified）
FDA 专业组: Unknown
上市路径: HDE - Humanitarian Device Exemption

FDA 分类定义

The test is a qualitative prognostic test intended to be used in patients less than 21 years old with liver or small bowel transplantation. The test is an aid in the evaluation of the risk of acute cellular rejection (ACR) and must be used in conjunction with biopsy, standard clinical assessment and other laboratory information.

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： PHK

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。