Product code OJY— Microbiology
NP Screen
- Classification name
- Device To Detect Or Measure Nucleic Acid From Viruses Associated With Head And Neck Cancers
- Device class
- Class 2
- Regulation
- 21 CFR 866.3236
- Advisory panel
- Microbiology
- Total cleared
- 1
- First cleared
- Most recent
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.”
Market context for product code OJY
FDA has cleared device under product code OJY, all in 2020, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Top applicants under product code OJY
Recent clearances under product code OJY
Data sourced from openFDA. This site is unofficial and independent of the FDA.