Product code
PDS: Amniotic fluid protein immunoassay
FDA product code · Class I · Clinical Chemistry
Key facts
| Product code | PDS |
|---|---|
| Device | Amniotic fluid protein immunoassay |
| Device class | Class I |
| Regulation number | 862.1550 |
| Review panel | Clinical Chemistry |
| Medical specialty | Clinical Chemistry |
| Submission type | 510(k) |
| GMP exempt | No |
| Implanted device | No |
| Life-sustaining or life-supporting | No |
| Definition | To detect specified amniotic fluid proteins in cervicovaginal samples |
At a glance
- None 510(k) clearances
- None De Novo grants
- None PMA approvals
- None HDE approvals
- None 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