K Number
K251595Device Name
COVID-19 Detect Rapid Self -TestManufacturer
Date Cleared
2025-10-12
(138 days)
Product Code
Regulation Number
866.3984Type
TraditionalPanel
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