OYX

Bcr/Abl1 Monitoring Test

产品代码

OYX

器械名称

Bcr/Abl1 Monitoring Test

管理类别

第 2 类（Class II）

21 CFR 条款

21 CFR 866.6060

FDA 专业组

Medical Genetics

上市路径

需提交 510(k) 上市前通告

该代码近三年的 510(k)

6 件

FDA 分类定义

A BCR/ABL1 Monitoring Test is a quantitative in vitro diagnostic device used to monitor the BCR/ABL1 to ABL1 ratio by reverse-transcriptase quantitative polymerase chain reaction (RQ-PCR) on whole blood or bone marrow of diagnosed Philadelphia chromosome positive (Ph+) chronic myeloid leukemia (CML) patients expressing BCR-ABL1 fusion transcripts such as e13a2 and/or e14a2. It is intended for use during monitoring of treatment response by reporting results on the international scale (%IS) and as log molecular reduction (MR) value.

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）。

该代码近三年的 510(k)（1 件）

数据窗口为最近三年。最新一件：2026-07-02。