FDA product code OJY

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

Microbiology·Class 2·21 CFR 866.3236
US regulatory classifications
US Product Code (FDA)
OJY
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US Risk Class (FDA)
Class 2
US Regulation (CFR)
21 CFR 866.3236
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Medical specialty
Microbiology
Device characteristics
GMP exempt
No
Implantable
No
Life-sustaining
No
Third party review
Not Eligible
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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About this record

Device To Detect Or Measure Nucleic Acid From Viruses Associated With Head And Neck Cancers is a medical device type in the Microbiology specialty. This page includes real-world medical device registration data worldwide for this device type, with registrations from US FDA, Brazil ANVISA, and other global markets.

View regulatory classifications, recent 510(k) clearances, active device registrations, and similar products registered globally under this device category. Pure Global AI's free directory provides comprehensive worldwide registration intelligence across 7,000+ medical device types and 21 specialties.