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 Crohns disease or ulcerative colitis.
- Source
- FDA openFDA device classification dataset
Related 510(k) Records
| 510(k) | Device | Applicant | Decision date |
|---|
| DEN210056 | Procise IFX | Procisedx, Inc. | 2023-09-29 |
Related GUDID Devices
| Primary DI | Brand | Company | Published |
|---|
| 08100322953854 | Procise IFX | PROCISEDX Inc. | 2024-08-16 |