21 CFR 862.3035 — Amikacin Serum Assay
Clinical Toxicology (TX) · Subpart D—Clinical Toxicology Test Systems · § 862.3035
Identification
An amikacin test system is a device intended to measure amikacin, an aminoglycoside antibiotic drug, in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of amikacin overdose and in monitoring levels of amikacin to ensure appropriate therapy.
Classification Rationale
Class II.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| KLP | Amikacin Serum Assay | 2 | 4 | 3rd Party |
| KLQ | Radioimmunoassay, Amikacin | 2 | 20 | 3rd Party |
| LDN | Enzymatic Radiochemical Assay, Amikacin | 2 | 3 | 3rd Party |
| LGJ | Fluorescence Polarization Immunoassay, Amibacin | 2 | 3 | 3rd Party |
