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