Product code
ORL: Whole blood pre-treatment t-cell enrichment reagent
FDA product code · Class III · Microbiology
Key facts
| Product code | ORL |
|---|---|
| Device | Whole blood pre-treatment t-cell enrichment reagent |
| Device class | Class III |
| Review panel | Microbiology |
| Submission type | PMA |
| GMP exempt | No |
| Implanted device | No |
| Life-sustaining or life-supporting | No |
| Definition | The reagent is for the pre-treatment of whole blood prior to lymphocyte separation. The reagent aids in the removal of selected white blood cells from whole blood stored at room temperature (18-25°C). |
At a glance
- None 510(k) clearances
- None De Novo grants
- None PMA approvals
- None HDE approvals
- None UDI devices (GUDID)
- 1–9 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