SBL
- 产品代码
- SBL
- 器械名称
- Immunohistochemistry Assay, Antibody, Melanoma-Associated Antigen A4
- 管理类别
- 第 3 类（Class III）
- 21 CFR 条款
- 21 CFR 864.1860
- FDA 专业组
- Hematology
- 上市路径
- 需 PMA 上市前批准
FDA 分类定义
Melanoma-associated antigen A4 (MAGE-A4) antibody is a qualitative immunohistochemical antibody, intended for use in the detection of MAGE-A4 protein expression in human clinical tissue specimens. The MAGE A4 antibody is indicated as an aid in identifying patients eligible for treatment with specific FDA approved therapeutic drugs.
FDA 官方分类页： SBL
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。