FDA product code QXT: Infliximab Test System
QXT is the FDA product code for infliximab test system. It is a Class II device, regulated under 21 CFR 862.3115 and reviewed by the Clinical Toxicology panel. Devices under QXT reach the market by 510(k); FDA lists no cleared 510(k)s for it. 1 De Novo request was granted under it.
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.
Classification
| Field | Value |
|---|---|
| Device name | Infliximab Test System |
| Device class | Class II |
| Regulation | 21 CFR 862.3115 |
| Review panel | TX — Clinical Toxicology |
| Medical specialty | Clinical Toxicology |
| Premarket route | 510(k) |
Recalls for QXT devices
openFDA lists no recalls for product code QXT.
Frequently asked questions
What is FDA product code QXT?
QXT is the FDA product code for infliximab test system. It is a Class II device, regulated under 21 CFR 862.3115 and reviewed by the Clinical Toxicology panel.
What device class is QXT?
Class II, regulation 21 CFR 862.3115. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code QXT
- Run a recall and safety report across every QXT manufacturer
- Watch product code QXT for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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