Product code
QUD: Blood detection capsule
FDA product code · Class II · Gastroenterology/Urology
Key facts
| Product code | QUD |
|---|---|
| Device | Blood detection capsule |
| Device class | Class II |
| Regulation number | 876.1390 |
| Review panel | Gastroenterology/Urology |
| Medical specialty | Gastroenterology/Urology |
| Submission type | 510(k) |
| GMP exempt | No |
| Implanted device | No |
| Life-sustaining or life-supporting | No |
| 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. |
At a glance
- None 510(k) clearances
- 1–9 De Novo grants
- None PMA approvals
- None HDE approvals
- 1–9 UDI devices (GUDID)
- None MAUDE adverse event reports
- None Recalled products (Z-numbers)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device product codes
FDA product codes classify medical devices by type and intended use; each code maps to a device class, a classification regulation and a review panel.
Source: U.S. Food and Drug Administration (FDA), Product Classification database