GMO — Antigen, Latex Agglutination, Entamoeba Histolytica & Rel. Spp. Class II

FDA Device Classification

FDA product code GMO covers "Antigen, Latex Agglutination, Entamoeba Histolytica & Rel. Spp.", a Class II medical device regulated under 21 CFR 866.3220. Submissions are reviewed by the Microbiology panel.

Classification Details

Product Code
GMO
Device Class
Class II
Regulation Number
866.3220
Submission Type
Review Panel
MI
Medical Specialty
Microbiology
Implant
No