QXT
1 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Infliximab Test System
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.3115
- Medical specialty
- Clinical Toxicology
- FDA 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.
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| Record | Firm | Date |
|---|---|---|
| Procise IFX (DEN210056) | Procisedx, Inc. | 2023-09-29 |
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