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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 simple point-of-care device to directly detect sars-cov-2 viral targets from clinical specimens in near-patient settings
De Novo Number DEN220039
Device Name Sofia 2 SARS Antigen+ FIA, Sofia 2 SARS Antigen+ FIA Control Swab Set
Quidel Corporation
10165 mckellar court
san diego,  CA  92121
Contact xiaoxi wang
Regulation Number866.3982
Classification Product Code
Date Received06/16/2022
Decision Date 03/08/2023
Decision granted (DENG)
Classification Advisory Committee Microbiology
Review Advisory Committee Microbiology
Reclassification Order Reclassification Order
FDA Review Decision Summary
Type Post-NSE