FDA product code QUD: Blood Detection Capsule
QUD is the FDA product code for blood detection capsule. It is a Class II device, regulated under 21 CFR 876.1390 and reviewed by the Gastroenterology and Urology panel. Devices under QUD reach the market by 510(k); FDA lists no cleared 510(k)s for it. 1 De Novo request was granted under it.
Definition
Ingestible gastrointestinal blood detection capsule device is a prescription device that uses spectrophotometry (light absorption technology) to detect the presence or absence of blood in the gastrointestinal tract.
Classification
| Field | Value |
|---|---|
| Device name | Blood Detection Capsule |
| Device class | Class II |
| Regulation | 21 CFR 876.1390 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) |
Recalls for QUD devices
openFDA lists no recalls for product code QUD.
Frequently asked questions
What is FDA product code QUD?
QUD is the FDA product code for blood detection capsule. It is a Class II device, regulated under 21 CFR 876.1390 and reviewed by the Gastroenterology and Urology panel.
What device class is QUD?
Class II, regulation 21 CFR 876.1390. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code QUD
- Run a recall and safety report across every QUD manufacturer
- Watch product code QUD 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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