K Number
DEN240020Device Name
Visby Medical Women's Sexual Health TestManufacturer
Date Cleared
2025-03-28
(319 days)
Product Code
Regulation Number
866.3386Type
DirectPanel
MicrobiologyReference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
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N/A