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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 microorganism(s) causing sexually transmitted infections performed by lay users
De Novo Number DEN240020
Device Name Visby Medical Women's Sexual Health Test
Requester
visby medical, inc.
3010 n. first st.
san jose,  CA  95134
Contact jennifer albrecht
Regulation Number866.3386
Classification Product Code
SEA  
Date Received05/13/2024
Decision Date 03/28/2025
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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