OJY

Device To Detect Or Measure Nucleic Acid From Viruses Associated With Head And Neck Cancers

产品代码

OJY

器械名称

Device To Detect Or Measure Nucleic Acid From Viruses Associated With Head And Neck Cancers

管理类别

第 2 类（Class II）

21 CFR 条款

21 CFR 866.3236

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)

1 件（全部年份；本站只收录近三年的明细）

FDA 分类定义

A device to detect or measure nucleic acid from viruses associated with head and neck cancers is an in vitro diagnostic test for prescription use in the detection of viral nucleic acid in nasopharyngeal or oropharyngeal cellular specimens from patients with signs and symptoms of head and neck cancer. The test result is intended to be used in conjunction with other clinical information to aid in assessing the clinical status of virus-associated head and neck cancers and/or the likelihood that head and neck cancer is present.

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）。