QKO — Reagent, Coronavirus Serological Class N
FDA product code QKO covers "Reagent, Coronavirus Serological", a Class N medical device. Submissions are reviewed by the Unknown panel.
Classification Details
- Product Code
- QKO
- Device Class
- Class N
- Regulation Number
- Submission Type
- Review Panel
- MI
- Medical Specialty
- Unknown
- Implant
- No
Definition
The qualitative detection of IgM and/or IgG antibodies to coronavirus from human specimens.