NID

Assay, Proliferation, In Vitro, T Lymphocyte

产品代码

NID

器械名称

Assay, Proliferation, In Vitro, T Lymphocyte

管理类别

第 2 类（Class II）

21 CFR 条款

21 CFR 864.5220

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

A device measuring the constituents of dividing DNA or other pre-division cellular constituents to classify the ability of T lymphocytes (a type of normal white blood mononuclear cell) to divide or proliferate in response to specific or non-specific added stimulants. The T lymphocytes may be normal in number or abnormally low in number due to a natural or induced immunosuppressed state in the patient.

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）。