GPE — Antisera, Positive Control, Echinococcus Spp. Class I

FDA Device Classification

FDA product code GPE covers "Antisera, Positive Control, Echinococcus Spp.", a Class I medical device regulated under 21 CFR 866.3200. Submissions are reviewed by the Microbiology panel.

Classification Details

Product Code
GPE
Device Class
Class I
Regulation Number
866.3200
Submission Type
Review Panel
MI
Medical Specialty
Microbiology
Implant
No