QKP — Coronavirus Antigen Detection Test System. Class N
FDA product code QKP covers "Coronavirus Antigen Detection Test System.", a Class N medical device. Submissions are reviewed by the Unknown panel.
Classification Details
- Product Code
- QKP
- Device Class
- Class N
- Regulation Number
- Submission Type
- Review Panel
- MI
- Medical Specialty
- Unknown
- Implant
- No
Definition
The qualitative detection of coronavirus viral antigens directly from clinical specimens.