FDA product code GII: Glutathione, Red-Cell
GII is the FDA product code for glutathione, red-cell. It is a Class II device, regulated under 21 CFR 864.7375 and reviewed by the Hematology panel. Devices under GII reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Glutathione, Red-Cell |
| Device class | Class II |
| Regulation | 21 CFR 864.7375 |
| Review panel | HE — Hematology |
| Medical specialty | Hematology |
| Premarket route | 510(k) exempt |
Recalls for GII devices
openFDA lists no recalls for product code GII.
Frequently asked questions
What is FDA product code GII?
GII is the FDA product code for glutathione, red-cell. It is a Class II device, regulated under 21 CFR 864.7375 and reviewed by the Hematology panel.
What device class is GII?
Class II, regulation 21 CFR 864.7375. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code GII
- Run a recall and safety report across every GII manufacturer
- Watch product code GII 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.