QHM — Serology Tests Used For Infectious Disease Screening Of Blood And Plasma Donations Class U
FDA product code QHM covers "Serology Tests Used For Infectious Disease Screening Of Blood And Plasma Donations", a Class U medical device regulated under 21 CFR 610.40. Submissions are reviewed by the Microbiology panel.
Classification Details
- Product Code
- QHM
- Device Class
- Class U
- Regulation Number
- 610.40
- Submission Type
- Review Panel
- MI
- Medical Specialty
- Microbiology
- Implant
- No
Definition
For the qualitative detection of antibodies or antigens to infectious disease agents in human specimens