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K Number
K955569
Device Name
INNOFLUOR GENTAMICIN ASSAY SYSTEM
Manufacturer
OXIS INTL., INC.
Date Cleared
1996-02-09

(65 days)

Product Code
LCQ
Regulation Number
862.3450
Type
Traditional
Panel
Toxicology
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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§ 862.3450 Gentamicin test system.

(a)
Identification. A gentamicin test system is a device intended to measure gentamicin, an antibiotic drug, in human specimens. Measurements obtained by this device are used in the diagnosis and treatment of gentamicin overdose and in monitoring levels of gentamicin to ensure appropriate therapy.(b)
Classification. Class II.