ROCHE COBAS-FP REAGENTS FOR TOBRAMYCIN

• K Number: K964670
• Device Name: ROCHE COBAS-FP REAGENTS FOR TOBRAMYCIN
• Manufacturer: ROCHE DIAGNOSTIC SYSTEMS, INC.
• Date Cleared: 1997-02-04 ( 75 days)
• Product Code: LFW
• Regulation Number: 862.3900
• Type: Traditional
• Panel: Toxicology
• Age Range: N/A
• Reference & Predicate Devices: N/A
• Predicate For: N/A

Intended Use

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Device Description

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AI/ML Overview

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Summary

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Regulation Number and Section

§ 862.3900 Tobramycin test system.

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