FDA product code GMO: Antigen, Latex Agglutination, Entamoeba Histolytica & Rel. Spp.
GMO is the FDA product code for antigen, latex agglutination, entamoeba histolytica & rel. spp.. It is a Class II device, regulated under 21 CFR 866.3220 and reviewed by the Microbiology panel. Devices under GMO reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Antigen, Latex Agglutination, Entamoeba Histolytica & Rel. Spp. |
| Device class | Class II |
| Regulation | 21 CFR 866.3220 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) exempt |
Recalls for GMO devices
openFDA lists no recalls for product code GMO.
Frequently asked questions
What is FDA product code GMO?
GMO is the FDA product code for antigen, latex agglutination, entamoeba histolytica & rel. spp.. It is a Class II device, regulated under 21 CFR 866.3220 and reviewed by the Microbiology panel.
What device class is GMO?
Class II, regulation 21 CFR 866.3220. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code GMO
- Run a recall and safety report across every GMO manufacturer
- Watch product code GMO 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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