GMR — Sera, Reactive And Non-Specific Control, Fta-Abs Test Class II

FDA Device Classification

FDA product code GMR covers "Sera, Reactive And Non-Specific Control, Fta-Abs Test", a Class II medical device regulated under 21 CFR 866.3830. Submissions are reviewed by the Microbiology panel.

Classification Details

Product Code
GMR
Device Class
Class II
Regulation Number
866.3830
Submission Type
Review Panel
MI
Medical Specialty
Microbiology
Implant
No