GQM — Antisera, Neutralization, Herpesvirus Hominis Class II
FDA product code GQM covers "Antisera, Neutralization, Herpesvirus Hominis", a Class II medical device regulated under 21 CFR 866.3305. Submissions are reviewed by the Microbiology panel. At least 3 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- GQM
- Device Class
- Class II
- Regulation Number
- 866.3305
- Submission Type
- Review Panel
- MI
- Medical Specialty
- Microbiology
- Implant
- No