FDA product code NAH: System, Test, Tumor Marker, For Detection Of Bladder Cancer
NAH is the FDA product code for system, test, tumor marker, for detection of bladder cancer. It is a Class III device, reviewed by the Immunology panel. Devices under NAH reach the market by PMA; FDA lists no cleared 510(k)s for it. 2 PMA applications cite this product code.
Classification
| Field | Value |
|---|---|
| Device name | System, Test, Tumor Marker, For Detection Of Bladder Cancer |
| Device class | Class III |
| Review panel | IM — Immunology |
| Medical specialty | Unknown |
| Premarket route | PMA |
Recalls for NAH devices
openFDA lists no recalls for product code NAH.
Frequently asked questions
What is FDA product code NAH?
NAH is the FDA product code for system, test, tumor marker, for detection of bladder cancer. It is a Class III device, reviewed by the Immunology panel.
What device class is NAH?
Class III. Typical premarket route: PMA.
Next steps
- Run an FDA pathway report with predicate devices for product code NAH
- Run a recall and safety report across every NAH manufacturer
- Watch product code NAH 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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