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K Number
DEN240035
Device Name
ConcizuTrace™ ELISA
Manufacturer
Randox Laboratories Ltd
Date Cleared
2025-05-22

(325 days)

Product Code
SES
Regulation Number
864.7298
Type
Direct
Panel
Hematology
Reference & 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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