PKW
- 产品代码
- PKW
- 器械名称
- Immunohistochemistry Assay, Antibody, Anaplastic Lymphoma Kinase
- 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 anaplastic lymphoma kinase (ALK) antibody is a qualitative immunohistochemical antibody intended to identify ALK protein expression in human clinical tissue specimens. The ALK antibody is indicated as an aid in identifying patients eligible for treatment with specific FDA approved therapeutic drugs.
FDA 官方分类页： PKW
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。