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U.S. Department of Health and Human Services

Device Classification Under Section 513(f)(2)(De Novo)

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Device Classification Name device to detect or measure nucleic acid from viruses associated with head and neck cancers
De Novo Number DEN190031
Device Name NP Screen
Advance Sentry Corporation
7155 woodbine avenue, suite 202
markham,  CA l3r 1a3
Contact leo chui
Regulation Number866.3236
Classification Product Code
Date Received06/24/2019
Decision Date 05/11/2020
Decision granted (DENG)
Classification Advisory Committee Microbiology
Review Advisory Committee Microbiology
Reclassification Order Reclassification Order
FDA Review Decision Summary
Type Direct