Product code
PQQ: Data acquisition software
FDA product code · Class II · Microbiology
Key facts
| Product code | PQQ |
|---|---|
| Device | Data acquisition software |
| Device class | Class II |
| Regulation number | 862.2570 |
| Review panel | Microbiology |
| Medical specialty | Clinical Chemistry |
| Submission type | 510(K) Exempt |
| GMP exempt | No |
| Implanted device | No |
| Life-sustaining or life-supporting | No |
| Definition | Software that integrates a network of sample pooling instruments, and manages the overall blood analysis sample workflow. Software acquires and processes data from various donor screening, diagnostic, multiplex assay instruments. |
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
- 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