21 CFR 862.3555 — Enzyme Immunoassay, Lidocaine
Clinical Toxicology (TX) · Subpart D—Clinical Toxicology Test Systems · § 862.3555
Identification
A lidocaine test system is a device intended to measure lidocaine, an antiarrythmic and anticonvulsant drug, in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of lidocaine overdose or in monitoring levels of lidocaine to ensure appropriate therapy.
Classification Rationale
Class II.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| KLR | Enzyme Immunoassay, Lidocaine | 2 | 17 | 3rd Party |
