OJY — Device To Detect Or Measure Nucleic Acid From Viruses Associated With Head And Neck Cancers Class II
FDA product code OJY covers "Device To Detect Or Measure Nucleic Acid From Viruses Associated With Head And Neck Cancers", a Class II medical device regulated under 21 CFR 866.3236. Submissions are reviewed by the Microbiology panel. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- OJY
- Device Class
- Class II
- Regulation Number
- 866.3236
- Submission Type
- Review Panel
- MI
- Medical Specialty
- Microbiology
- Implant
- No
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| DEN190031 | advance sentry corporation | NP Screen | May 11, 2020 |