FDA product code MWO: Reagent, Blood Bank, Quality Control
MWO is the FDA product code for reagent, blood bank, quality control. It is a Not classified device, reviewed by the Hematology panel. Devices under MWO reach the market by Contact FDA; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Reagent, Blood Bank, Quality Control |
| Device class | Not classified |
| Review panel | HE — Hematology |
| Medical specialty | Unknown |
| Premarket route | Contact FDA |
Recalls for MWO devices
openFDA lists no recalls for product code MWO.
Frequently asked questions
What is FDA product code MWO?
MWO is the FDA product code for reagent, blood bank, quality control. It is a Not classified device, reviewed by the Hematology panel.
What device class is MWO?
Not classified. Typical premarket route: Contact FDA.
Next steps
- Run an FDA pathway report with predicate devices for product code MWO
- Run a recall and safety report across every MWO manufacturer
- Watch product code MWO 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.