QXT — Infliximab Test System Class II
FDA product code QXT covers "Infliximab Test System", a Class II medical device regulated under 21 CFR 862.3115. Submissions are reviewed by the Clinical Toxicology panel. At least 1 recent 510(k) clearance has been granted under this product code.
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 |