Product code
PJE: Blood/plasma collection device for dna testing
FDA product code · Class II · Clinical Chemistry
Key facts
| Product code | PJE |
|---|---|
| Device | Blood/plasma collection device for dna testing |
| 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 | A blood collection device for DNA testing is an in vitro diagnostics device intended to collect and transport blood specimens to the laboratory for clinical DNA testing. |
At a glance
- 1–9 510(k) clearances
- None De Novo grants
- None PMA approvals
- None HDE approvals
- 10–99 UDI devices (GUDID)
- 100–999 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