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