QUK
- 产品代码
- QUK
- 器械名称
- Human Leukocyte Antigen (Hla) Typing Companion Diagnostic Test
- 管理类别
- 第 2 类（Class II）
- 21 CFR 条款
- 21 CFR 866.5960
- FDA 专业组
- Immunology
- 上市路径
- 需提交 510(k) 上市前通告
FDA 分类定义
A Human Leukocyte Antigen (HLA) Typing Companion Diagnostic (CDx) Test is a prescription genotyping or phenotyping assay intended for use as an aid in identifying patients who have specific HLA allele(s) or express specific HLA antigen(s) and may benefit from treatment with a corresponding therapeutic product, or are likely to be at increased risk for serious adverse reactions as a result of treatment with a corresponding therapeutic product.
FDA 官方分类页： QUK
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。