OYY
- 产品代码
- OYY
- 器械名称
- Leukemia Translocation Panel Multiplex Test
- 管理类别
- 第 N 类（Not Classified）
- FDA 专业组
- Unknown
- 上市路径
- Contact ODE
FDA 分类定义
The leukemia translocation panel multiplex test is a qualitative in vitro diagnostic device intended to identify specific fusion transcripts by reverse-transcriptase polymerase chain reaction (rt-pcr) from whole blood or bone marrow. It is intended for use as an aid in the diagnosis of recurrent balanced or reciprocal translocation positive acute and chronic myeloid leukemia, acute lymphocytic or promyelocytic leukemias.
FDA 官方分类页： OYY
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。