Manufacturer
Date Cleared
2025-12-23
(146 days)
Product Code
Regulation Number
866.3176Type
DirectPanel
MicrobiologyAge Range
N/A
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
Loading...
N/A