FDA product code PJF: Illuminator System For Blood Products
PJF is the FDA product code for illuminator system for blood products. It is a Class III device, reviewed by the Hematology panel. Devices under PJF reach the market by PMA; FDA lists no cleared 510(k)s for it.
Definition
Preparation and storage of pathogen-reduced, blood components.
Classification
| Field | Value |
|---|---|
| Device name | Illuminator System For Blood Products |
| Device class | Class III |
| Review panel | HE — Hematology |
| Medical specialty | Unknown |
| Premarket route | PMA |
Recalls for PJF devices
openFDA lists no recalls for product code PJF.
Frequently asked questions
What is FDA product code PJF?
PJF is the FDA product code for illuminator system for blood products. It is a Class III device, reviewed by the Hematology panel.
What device class is PJF?
Class III. Typical premarket route: PMA.
Next steps
- Run an FDA pathway report with predicate devices for product code PJF
- Run a recall and safety report across every PJF manufacturer
- Watch product code PJF 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.