GME — Antisera, Fluorescent, Cryptococcus Neoformans Class II
FDA product code GME covers "Antisera, Fluorescent, Cryptococcus Neoformans", a Class II medical device regulated under 21 CFR 866.3165. Submissions are reviewed by the Microbiology panel.
Classification Details
- Product Code
- GME
- Device Class
- Class II
- Regulation Number
- 866.3165
- Submission Type
- Review Panel
- MI
- Medical Specialty
- Microbiology
- Implant
- No