GML — Antisera, Fluorescent, Histoplasma Capsulatum Class II
FDA product code GML covers "Antisera, Fluorescent, Histoplasma Capsulatum", a Class II medical device regulated under 21 CFR 866.3320. Submissions are reviewed by the Microbiology panel.
Classification Details
- Product Code
- GML
- Device Class
- Class II
- Regulation Number
- 866.3320
- Submission Type
- Review Panel
- MI
- Medical Specialty
- Microbiology
- Implant
- No