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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 multi-analyte respiratory virus antigen detection test
De Novo Number DEN240029
Device Name Healgen Rapid Check COVID-19/Flu A&B Antigen Test
Requester
healgen
3818 fuqua street
houston,  TX  77047
Contact bingliang fang
Regulation Number866.3987
Classification Product Code
SCA  
Date Received06/07/2024
Decision Date 10/07/2024
Decision granted (DENG)
Classification Advisory Committee Microbiology
Review Advisory Committee Microbiology
Classification Order Classification Order
FDA Review Decision Summary
Type Direct
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