COBAS REAGENT FOR LIDOCAINE & CALIBRATORS
Device Facts
| Record ID | K853010 |
|---|---|
| Device Name | COBAS REAGENT FOR LIDOCAINE & CALIBRATORS |
| Applicant | Roche Diagnostic Systems, Inc. |
| Product Code | KLR · Clinical Toxicology |
| Decision Date | Aug 7, 1985 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.3555 |
| Device Class | Class 2 |
Regulatory Classification
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.
