GTI — Antisera, Fluorescent, All Groups, N. Meningitidis Class II
FDA product code GTI covers "Antisera, Fluorescent, All Groups, N. Meningitidis", a Class II medical device regulated under 21 CFR 866.3390. Submissions are reviewed by the Microbiology panel. At least 2 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- GTI
- Device Class
- Class II
- Regulation Number
- 866.3390
- Submission Type
- Review Panel
- MI
- Medical Specialty
- Microbiology
- Implant
- No