Product code
PTH: Test, barbiturate, over the counter
FDA product code · Class II · Toxicology
Key facts
| Product code | PTH |
|---|---|
| Device | Test, barbiturate, over the counter |
| Device class | Class II |
| Regulation number | 862.3150 |
| Review panel | Toxicology |
| Medical specialty | Toxicology |
| Submission type | 510(k) |
| GMP exempt | No |
| Implanted device | No |
| Life-sustaining or life-supporting | No |
| Definition | The barbiturate test is an in vitro diagnostic test for the qualitative analysis of barbiturates in human urine. |
At a glance
- 1–9 510(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