Product code
NIJ: System, test, genotypic detection, resistant markers, enterococcus species
FDA product code · Class II · Microbiology
Key facts
| Product code | NIJ |
|---|---|
| Device | System, test, genotypic detection, resistant markers, enterococcus species |
| Device class | Class II |
| Regulation number | 866.1640 |
| Review panel | Microbiology |
| Medical specialty | Microbiology |
| Submission type | 510(k) |
| GMP exempt | No |
| Implanted device | No |
| Life-sustaining or life-supporting | No |
| Definition | The in vitro device is intended to detect the presence of the vanA and vanB genes in isolated colonies of Enterococcus spp. as a marker for vancomycin resistance using DNA probe technology |
At a glance
- 1–9 510(k) clearances
- None De Novo grants
- None PMA approvals
- None HDE approvals
- 1–9 UDI devices (GUDID)
- None 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