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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device device to detect or measure nucleic acid from viruses associated with head and neck cancers
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.
Product CodeOJY
Regulation Number 866.3236
Device Class 2


Premarket Reviews
ManufacturerDecision
ADVANCE SENTRY CORPORATION
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