21 CFR 862.3450 — Radioimmunoassay, Gentamicin (125-I), Second Antibody Sep.
Clinical Toxicology (TX) · Subpart D—Clinical Toxicology Test Systems · § 862.3450
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.
Classification Rationale
Class II.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| DJB | Radioimmunoassay, Gentamicin (125-I), Second Antibody Sep. | 2 | 19 | 3rd Party |
| DJI | Antiserum, Gentamicin | 2 | 1 | 3rd Party |
| DKD | Bacillus Subtilis, Microbiological Assay, Gentamicin | 2 | 2 | 3rd Party |
| DNO | Hemagglutination Inhibition, Gentamicin | 2 | 1 | 3rd Party |
| KLO | Enzymatic Radiochemical Assay, Gentamicin | 2 | 0 | 3rd Party |
| KZT | Kit, Disc, Agar Gel Diffusion, Determine Serum Levels Of Gentamicin | 2 | 1 | 3rd Party |
| LCD | Enzyme Immunoassay, Gentamicin | 2 | 37 | 3rd Party |
| LCE | Radioimmunoassay, Netilmicin (I-125) | 2 | 6 | |
| LCQ | Fluorescent Immunoassay Gentamicin | 2 | 19 | 3rd Party |
