FDA product code ORH
Lamotrigine Assay
Clinical Toxicology·Class 2·21 CFR 862.3350
US regulatory classifications
- US Product Code (FDA)
- ORHView Product Code Classification →
- US Risk Class (FDA)
- Class 2
- US Regulation (CFR)
- 21 CFR 862.3350View CFR Regulation →
- Medical specialty
- Clinical Toxicology
Device characteristics
- GMP exempt
- No
- Implantable
- No
- Life-sustaining
- No
- Third party review
- Eligible
Definition
for the quantitative determination of lamotrigine in human serum or plasma on automated clinical chemistry analyzers.
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About this record
Lamotrigine Assay is a medical device type in the Clinical Toxicology specialty. This page includes real-world medical device registration data worldwide for this device type, with registrations from US FDA, Brazil ANVISA, and other global markets.
View regulatory classifications, recent 510(k) clearances, active device registrations, and similar products registered globally under this device category. Pure Global AI's free directory provides comprehensive worldwide registration intelligence across 7,000+ medical device types and 21 specialties.