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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 over-the-counter molecular test to detect sars-cov-2 from clinical specimens
De Novo Number DEN220028
Device Name Cue COVID-19 Molecular Test
Cue Health Inc.
4980 carroll canyon road suite 100
san diego,  CA  92121
Contact roderick castillo
Regulation Number866.3984
Classification Product Code
Date Received05/02/2022
Decision Date 06/06/2023
Decision granted (DENG)
Classification Advisory Committee Microbiology
Review Advisory Committee Microbiology
Reclassification Order Reclassification Order
FDA Review Decision Summary
Type Direct