Code of Federal Regulations (Last Updated: July 5, 2024) |
Title 21 - Food and Drugs |
Chapter I - Food and Drug Administration, Department of Health and Human Services |
SubChapter H - Medical Devices |
Part 862 - Clinical Chemistry and Clinical Toxicology Devices |
Subpart D - Clinical Toxicology Test Systems |
§ 862.3900 - Tobramycin test system.
Latest version.
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§ 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.