Product code
QBF: Test, propoxyphene, over the counter
FDA product code · Class II · Toxicology
Key facts
| Product code | QBF |
|---|---|
| Device | Test, propoxyphene, over the counter |
| Device class | Class II |
| Regulation number | 862.3700 |
| Review panel | Toxicology |
| Medical specialty | Toxicology |
| Submission type | 510(k) |
| GMP exempt | No |
| Implanted device | No |
| Life-sustaining or life-supporting | No |
| Definition | The propoxyphene test is an in vitro diagnostic test for the qualitative detection of propoxyphene in human urine. The test is intended for over-the-counter use as the first step in a two step process to provide consumers with information concerning the presence or absence of propoxyphene in a urine sample. |
At a glance
- 1–9 510(k) clearances
- None De Novo grants
- None PMA approvals
- None HDE approvals
- 10–99 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