QXT — Infliximab Test System Class II
Classification Details
- Product Code
- QXT
- Device Class
- Class II
- Regulation Number
- 862.3115
- Submission Type
- Review Panel
- TX
- Medical Specialty
- Clinical Toxicology
- Implant
- No
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| DEN210056 | procisedx | Procise IFX | September 29, 2023 |