GMX — Antisera, Fluorescent Antibody For Fta-Abs Test Class II
FDA product code GMX covers "Antisera, Fluorescent Antibody For 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
- GMX
- Device Class
- Class II
- Regulation Number
- 866.3830
- Submission Type
- Review Panel
- MI
- Medical Specialty
- Microbiology
- Implant
- No