Product code QYD
- Device name
- Adalimumab Assay
- Medical specialty
- Clinical Toxicology
- Device class
- 2
- Regulation number
- 862.3115
- Review panel
- TX
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Ineligible
- Definition
- An in vitro diagnostic device intended for the measurement of adalimumab, an anti-tumor necrosis factor alpha monoclonal antibody
- Source
- FDA openFDA device classification dataset