STRATUS LIDOCAINE FLUOROMETRIC ENZYME
Device Facts
| Record ID | K843184 |
|---|---|
| Device Name | STRATUS LIDOCAINE FLUOROMETRIC ENZYME |
| Applicant | American Dade |
| Product Code | KLR · Clinical Toxicology |
| Decision Date | Sep 26, 1984 |
| 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.
