Product code ORI
- Device name
- Levetiracetam Assay
- Medical specialty
- Clinical Toxicology
- Device class
- 2
- Regulation number
- 862.3350
- Review panel
- TX
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Definition
- For the quantitative determination of levetiracetam in human serum or plasma.
- Source
- FDA openFDA device classification dataset