ORH — Lamotrigine Assay Class II
Classification Details
- Product Code
- ORH
- Device Class
- Class II
- Regulation Number
- 862.3350
- Submission Type
- Review Panel
- TX
- Medical Specialty
- Clinical Toxicology
- Implant
- No
Definition
for the quantitative determination of lamotrigine in human serum or plasma on automated clinical chemistry analyzers.