OJY

1 FDA 510(k) clearances · Product code

FDA profile

Official device name

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

Device class

Class II (moderate risk)

Regulation

21 CFR 866.3236

Medical specialty

Microbiology

FDA definition

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.

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