Product code
PJD: Oral fluid drugs of abuse and alcohol test specimen collection device
FDA product code · Class II · Clinical Chemistry
Key facts
| Product code | PJD |
|---|---|
| Device | Oral fluid drugs of abuse and alcohol test specimen collection device |
| Device class | Class II |
| Regulation number | 862.1675 |
| Review panel | Clinical Chemistry |
| Medical specialty | Clinical Chemistry |
| Submission type | 510(k) |
| GMP exempt | No |
| Implanted device | No |
| Life-sustaining or life-supporting | No |
| Definition | Intended for use in the collection, preservation, and transport of oral fluid specimens for drugs of abuse or alcohol testing. |
At a glance
- 1–9 510(k) clearances
- None De Novo grants
- None PMA approvals
- None HDE approvals
- 10–99 UDI devices (GUDID)
- 10–99 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