Product code
PMY: System, nucleic acid amplification test, dna, carbapenem non-susceptible gram negative organism, colony
FDA product code · Class II · Microbiology
Key facts
| Product code | PMY |
|---|---|
| Device | System, nucleic acid amplification test, dna, carbapenem non-susceptible gram negative organism, colony |
| 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 | To detect the presence of genetic markers of antimicrobial resistance by testing isolated bacterial colonies using nucleic acid amplification technology. |
At a glance
- 1–9 510(k) clearances
- None De Novo grants
- None PMA approvals
- None HDE approvals
- 10–99 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