K Number
DEN160048Device Name
FilmArray NGDS Warrior PanelManufacturer
Date Cleared
2017-02-14
(120 days)
Product Code
Regulation Number
N/AType
DirectPanel
MIReference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
N/A