21 CFR 862.3950 — Radioimmunoassay, Vancomycin
Clinical Toxicology (TX) · Subpart D—Clinical Toxicology Test Systems · § 862.3950
Identification
A vancomycin test system is a device intended to measure vancomycin, an antibiotic drug, in serum. Measurements obtained by this device are used in the diagnosis and treatment of vancomycin overdose and in monitoring the level of vancomycin to ensure appropriate therapy.
Classification Rationale
Class II.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| LEH | Radioimmunoassay, Vancomycin | 2 | 31 | 3rd Party |
