NSF

Test, Alpha Fetoprotein L3 Subfraction (Afp-L3%), For Hepatocellular Carcinoma Risk Assessment

产品代码

NSF

器械名称

Test, Alpha Fetoprotein L3 Subfraction (Afp-L3%), For Hepatocellular Carcinoma Risk Assessment

管理类别

第 2 类（Class II）

21 CFR 条款

21 CFR 866.6030

FDA 专业组

Immunology

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

In vitro diagnostic test intended as a risk assessment test for the development of hepatocellular carcinoma (hcc) in patients with chronic liver diseases (cld). Elevated afpl3% values (= 10%) have been shown to be associated with a nine-fold increase in the risk of developing hcc in the next 6-12 months. Patients with elevated serum afpl3% should be more intensely evaluated for evidence of hcc according to the existing hcc practice guidelines in oncology.

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）。