GMO
- Product code
- GMO
- Device name
- Antigen, Latex Agglutination, Entamoeba Histolytica & Rel. Spp.
- Device class
- Class 2
- 21 CFR
- 21 CFR 866.3220
- Medical specialty
- Microbiology
- Marketing pathway
- 510(K) Exempt
Official FDA classification page: GMO
Classification and pathway per current FDA publications. Data from openFDA (CC0).