NJV

Test, Albumin Cobalt Binding

产品代码

NJV

器械名称

Test, Albumin Cobalt Binding

管理类别

第 2 类（Class II）

21 CFR 条款

21 CFR 862.1215

FDA 专业组

Clinical Chemistry

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

The Albumin Cobalt Binding Test is a quantitative in vitro diagnostic test used on human serum that detects Ischemia Modified Albumin by measuring the cobalt binding capacity of albumin in human serum. IMA is intended for use in conjunction with other tests such as ECG and cardiac troponin as an aid to the short term risk stratification of patients presenting with chest pain suggestive of cardiac origin.

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）。