Product code
QAW: Test, tricyclic antidepressants, over the counter
FDA product code · Class II · Toxicology
Key facts
| Product code | QAW |
|---|---|
| Device | Test, tricyclic antidepressants, over the counter |
| Device class | Class II |
| Regulation number | 862.3910 |
| Review panel | Toxicology |
| Medical specialty | Toxicology |
| Submission type | 510(k) |
| GMP exempt | No |
| Implanted device | No |
| Life-sustaining or life-supporting | No |
| Definition | Intended to measure any of the tricyclic antidepressant drugs in serum or urine. |
At a glance
- None 510(k) clearances
- None De Novo grants
- None PMA approvals
- None HDE approvals
- 100–999 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