FDA product code MWB: Kit, Test, Saliva, Hiv-1&2
MWB is the FDA product code for kit, test, saliva, hiv-1&2. It is a Class III device, reviewed by the Hematology panel. Devices under MWB reach the market by PMA; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Kit, Test, Saliva, Hiv-1&2 |
| Device class | Class III |
| Review panel | HE — Hematology |
| Medical specialty | Unknown |
| Premarket route | PMA |
Recalls for MWB devices
openFDA lists no recalls for product code MWB.
Frequently asked questions
What is FDA product code MWB?
MWB is the FDA product code for kit, test, saliva, hiv-1&2. It is a Class III device, reviewed by the Hematology panel.
What device class is MWB?
Class III. Typical premarket route: PMA.
Next steps
- Run an FDA pathway report with predicate devices for product code MWB
- Run a recall and safety report across every MWB manufacturer
- Watch product code MWB 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.
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