21 CFR 862.3900 — Bacillus Subtilis Microbiology Assay, Tobramycin

Clinical Toxicology (TX) · Subpart D—Clinical Toxicology Test Systems · § 862.3900

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.

Classification Rationale

Class II.

Product Codes

Product CodeDevice NameClassDevicesAttributes
DIDBacillus Subtilis Microbiology Assay, Tobramycin253rd Party
KLBRadioimmunoassay, Tobramycin2233rd Party
KZXKit, Disc, Agar Gel Diffusion, Determine Serum Levels Of Tobramycin203rd Party
LCRFluorescent Immunoassay, Tobramycin2173rd Party
LDOEnzymatic Radiochemical Assay, Tobramycin233rd Party
LFWFluorescence Polarization Immunoassay, Tobramycin2103rd Party
Innolitics

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