FDA product code IBE: Neuramininase (Sialidase)
IBE is the FDA product code for neuramininase (sialidase). It is a Class I device, regulated under 21 CFR 864.4400 and reviewed by the Pathology panel. Devices under IBE reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Neuramininase (Sialidase) |
| Device class | Class I |
| Regulation | 21 CFR 864.4400 |
| Review panel | PA — Pathology |
| Medical specialty | Pathology |
| Premarket route | 510(k) exempt |
Recalls for IBE devices
openFDA lists no recalls for product code IBE.
Frequently asked questions
What is FDA product code IBE?
IBE is the FDA product code for neuramininase (sialidase). It is a Class I device, regulated under 21 CFR 864.4400 and reviewed by the Pathology panel.
What device class is IBE?
Class I, regulation 21 CFR 864.4400. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code IBE
- Run a recall and safety report across every IBE manufacturer
- Watch product code IBE 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.