Product code QXT
- Device name
- Infliximab Test System
- 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 infliximab test system intended for the measurement of an infliximab as an aid in the management of patients with Crohn’s disease or ulcerative colitis.
- Source
- FDA openFDA device classification dataset