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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 for home collection and transport of vaginal specimens by lay users for use in an approved hpv molecular assay
De Novo Number DEN240045
Device Name Teal Wand
Requester
teal health, inc.
1012 torney ave
san francisco,  CA  94129
Contact trena depel
Regulation Number866.2920
Classification Product Code
SEP  
Date Received08/27/2024
Decision Date 05/09/2025
Decision granted (DENG)
Classification Advisory Committee Microbiology
Review Advisory Committee Microbiology
Classification Order Classification Order
FDA Review Decision Summary
Type Direct
Predetermined Change
Control Plan Authorized		 No
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