Product code
QHM: Serology tests used for infectious disease screening of blood and plasma donations
FDA product code · Unclassified · Microbiology
Key facts
| Product code | QHM |
|---|---|
| Device | Serology tests used for infectious disease screening of blood and plasma donations |
| Device class | Unclassified |
| Regulation number | 610.40 |
| Review panel | Microbiology |
| Medical specialty | Microbiology |
| Submission type | Contact ODE |
| GMP exempt | No |
| Implanted device | No |
| Life-sustaining or life-supporting | No |
| Definition | For the qualitative detection of antibodies or antigens to infectious disease agents in human specimens |
At a glance
- None 510(k) clearances
- None De Novo grants
- None PMA approvals
- None HDE approvals
- 10–99 UDI devices (GUDID)
- 100–999 MAUDE adverse event reports
- None Recalled products (Z-numbers)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device product codes
FDA product codes classify medical devices by type and intended use; each code maps to a device class, a classification regulation and a review panel.
Source: U.S. Food and Drug Administration (FDA), Product Classification database