Device Name
Elecsys Anti-SARS-CoV-2Manufacturer
Date Cleared
2025-12-17
(16 days)
Product Code
Regulation Number
866.3983Type
SpecialPanel
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