ORI — Levetiracetam Assay Class II
FDA product code ORI covers "Levetiracetam Assay", a Class II medical device regulated under 21 CFR 862.3350. Submissions are reviewed by the Clinical Toxicology panel. At least 2 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- ORI
- 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 levetiracetam in human serum or plasma.