SGW

Device To Detect Antibodies To Hepatitis D Virus

产品代码

SGW

器械名称

Device To Detect Antibodies To Hepatitis D Virus

管理类别

第 2 类（Class II）

21 CFR 条款

21 CFR 866.3176

FDA 专业组

Immunology

上市路径

需提交 510(k) 上市前通告

该代码近三年的 510(k)

1 件

其中 Summary 已存档

0 份，可直接下载

FDA 历史累计 510(k)

1 件（全部年份；本站只收录近三年的明细）

FDA 分类定义

The device to detect antibodies to hepatitis D Virus is an in vitro diagnostic device intended for prescription use for the detection of antibodies to the hepatitis D virus (anti-HDV) in human clinical specimens. The assay is intended as an aid in the diagnosis of HDV infection in individuals who are at risk for HDV infection. The assay is intended as an aid in diagnosis in conjunction with clinical findings and other diagnostic procedures. The assay is not intended for screening of blood, plasma, cells, or tissue donors.

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：2025-12-23。