EMIT 2000 TOBRAMYCIN ASSAY EMIT 2000 TOBRAMYCIN CALIBRATORS

• K Number: K003341
• Device Name: EMIT 2000 TOBRAMYCIN ASSAY EMIT 2000 TOBRAMYCIN CALIBRATORS
• Manufacturer: SYVA CO., DADE BEHRING, INC.
• Date Cleared: 2001-01-22 ( 89 days)
• Product Code: KLB , DLJ , LDO
• Regulation Number: 862.3900
• Type: Traditional
• Panel: CH
• Reference & Predicate Devices: N/A

Intended Use

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Device Description

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AI/ML Overview

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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.