Product code
PMN: Assayed external control material for microbiology nucleic acid amplification (nat) assays
FDA product code · Class II · Microbiology
Key facts
| Product code | PMN |
|---|---|
| Device | Assayed external control material for microbiology nucleic acid amplification (nat) assays |
| Device class | Class II |
| Regulation number | 866.3920 |
| Review panel | Microbiology |
| Medical specialty | Microbiology |
| Submission type | 510(k) |
| GMP exempt | No |
| Implanted device | No |
| Life-sustaining or life-supporting | No |
| Definition | Assayed external quality control material to monitor the performance of microbiology nucleic acid assays for in vitro diagnostic use. |
At a glance
- 10–99 510(k) clearances
- 1–9 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