Product code
KIS: Sera, animal and human
FDA product code · Class I · Pathology
Key facts
| Product code | KIS |
|---|---|
| Device | Sera, animal and human |
| Device class | Class I |
| Regulation number | 864.2800 |
| Review panel | Pathology |
| Medical specialty | Hematology |
| Submission type | 510(K) Exempt |
| GMP exempt | No |
| Implanted device | No |
| Life-sustaining or life-supporting | No |
At a glance
- 10–99 510(k) clearances
- None De Novo grants
- None PMA approvals
- None HDE approvals
- None UDI devices (GUDID)
- None MAUDE adverse event reports
- 1–9 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