Product code
QKP: Coronavirus antigen detection test system.
FDA product code · Not Classified · Microbiology
Key facts
| Product code | QKP |
|---|---|
| Device | Coronavirus antigen detection test system. |
| Device class | Not Classified |
| Review panel | Microbiology |
| Submission type | EUA - Emergency Use Authorization |
| GMP exempt | No |
| Implanted device | No |
| Life-sustaining or life-supporting | No |
| Definition | The qualitative detection of coronavirus viral antigens directly from clinical specimens. |
At a glance
- None 510(k) clearances
- None De Novo grants
- None PMA approvals
- None HDE approvals
- 100–999 UDI devices (GUDID)
- 1,000+ MAUDE adverse event reports
- 10–99 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