NQZ

Antigen, Invasive Fungal Pathogens

产品代码

NQZ

器械名称

Antigen, Invasive Fungal Pathogens

管理类别

第 2 类（Class II）

21 CFR 条款

21 CFR 866.3050

FDA 专业组

Microbiology

上市路径

需提交 510(k) 上市前通告

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

Invasive fungal pathogen assays are devices that consist of antigens, antisera, or proteases used in serological assays for the presumptive diagnosis of fungal infection in serum or plasma. The assay is indicated for use in patients with symptoms of, or medical conditions predisposing the patient to invasive fungal infection. The device can be used as an aid in the diagnosis of deep seated mycoses and fungemias. A positive result does not indicate which class of fungi may be causing infection. The assays should be used in conjunction with other diagnostic procedures, such as microbiological culture, histological examination of biopsy samples and radiological examination.

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）。