PLS

Immunohistochemistry Assay, Antibody, Programmed Death-Ligand 1

产品代码: PLS
器械名称: Immunohistochemistry Assay, Antibody, Programmed Death-Ligand 1
管理类别: 第 3 类（Class III）
FDA 专业组: Unknown
上市路径: 需 PMA 上市前批准

FDA 分类定义

The programmed death-ligand 1 (PD-L1) antibody is a qualitative immunohistochemical antibody intended to identify PD-L1 protein expression in human clinical tissue specimens. The PD-L1 antibody is indicated as an aid in identifying patients eligible for treatment with specific FDA approved therapeutic drugs or to assess PD-L1 expression level in patients who may respond particularly well to specific FDA approved therapeutic drugs.

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： PLS

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。