FDA product code ORL: Whole Blood Pre-Treatment T-Cell Enrichment Reagent
ORL is the FDA product code for whole blood pre-treatment t-cell enrichment reagent. It is a Class III device, reviewed by the Microbiology panel. Devices under ORL reach the market by PMA; FDA lists no cleared 510(k)s for it.
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).
Classification
| Field | Value |
|---|---|
| Device name | Whole Blood Pre-Treatment T-Cell Enrichment Reagent |
| Device class | Class III |
| Review panel | MI — Microbiology |
| Medical specialty | Unknown |
| Premarket route | PMA |
Recalls for ORL devices
openFDA lists no recalls for product code ORL.
Frequently asked questions
What is FDA product code ORL?
ORL is the FDA product code for whole blood pre-treatment t-cell enrichment reagent. It is a Class III device, reviewed by the Microbiology panel.
What device class is ORL?
Class III. Typical premarket route: PMA.
Next steps
- Run an FDA pathway report with predicate devices for product code ORL
- Run a recall and safety report across every ORL manufacturer
- Watch product code ORL for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.