FDA product code ORI
Levetiracetam Assay
Clinical Toxicology·Class 2·21 CFR 862.3350
US regulatory classifications
- US Product Code (FDA)
- ORIView 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 levetiracetam in human serum or plasma.
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About this record
Levetiracetam 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.