OJY

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

Product code

OJY

Device name

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

Device class

Class 2

21 CFR

21 CFR 866.3236

Medical specialty

Microbiology

Marketing pathway

510(K)

510(k) clearances (all years, FDA)

1 (all years; only the last 3 years are listed here)

FDA classification 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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).