Product code
QLC: Interleukin 6
FDA product code · Not Classified · Immunology
Key facts
| Product code | QLC |
|---|---|
| Device | Interleukin 6 |
| Device class | Not Classified |
| Review panel | Immunology |
| Submission type | EUA - Emergency Use Authorization |
| GMP exempt | No |
| Implanted device | No |
| Life-sustaining or life-supporting | No |
| Definition | In vitro Diagnostic devices for the quantitative determination of IL-6 (interleukin 6) in human specimens |
At a glance
- None 510(k) clearances
- None De Novo grants
- None PMA approvals
- None HDE approvals
- 1–9 UDI devices (GUDID)
- 10–99 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