PWD

Flow Cytometric Test System For Hematopoietic Neoplasms

产品代码

PWD

器械名称

Flow Cytometric Test System For Hematopoietic Neoplasms

管理类别

第 2 类（Class II）

21 CFR 条款

21 CFR 864.7010

FDA 专业组

Hematology

上市路径

需提交 510(k) 上市前通告

标记

可走第三方审查

FDA 历史累计 510(k)

2 件（全部年份；本站只收录近三年的明细）

FDA 分类定义

Reagents intended for in vitro diagnostic use as a panel for qualitative identification of cell populations by multiparameter immunophenotyping on a flow cytometer. These reagents are used as an aid in the differential diagnosis of hematologically abnormal patients having, or suspected of having the following hematopoietic neoplasms: chronic leukemia, acute leukemia, non-Hodgkin's lymphoma, myeloma, myelodysplastic syndrome (MDS), and/or myeloproliferative neoplasms (MPN)

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）。