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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 test for detection of antibodies associated with syphilis performed by lay users
De Novo Number DEN230090
Device Name First To Know Syphilis Test
Requester
nowdiagnostics
1200 stewart place
springdale,  AZ  72764
Contact kevin clark
Regulation Number866.3986
Classification Product Code
SBZ  
Date Received12/27/2023
Decision Date 08/16/2024
Decision granted (DENG)
Classification Advisory Committee Microbiology
Review Advisory Committee Microbiology
Classification Order Classification Order
Type Direct
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