Product code
NTM: Antigen, inflammatory response marker, sepsis
FDA product code · Class II · Microbiology
Key facts
| Product code | NTM |
|---|---|
| Device | Antigen, inflammatory response marker, sepsis |
| Device class | Class II |
| Regulation number | 866.3210 |
| Review panel | Microbiology |
| Medical specialty | Microbiology |
| Submission type | 510(k) |
| GMP exempt | No |
| Implanted device | No |
| Life-sustaining or life-supporting | No |
| Definition | An immunoluminometric assay used to determine the concentration of procalcitonin (pct) in human serum and plasma. |
At a glance
- 1–9 510(k) clearances
- None De Novo grants
- None PMA approvals
- None HDE approvals
- 10–99 UDI devices (GUDID)
- 1–9 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