FDA product code PDS: Amniotic Fluid Protein Immunoassay
PDS is the FDA product code for amniotic fluid protein immunoassay. It is a Class I device, regulated under 21 CFR 862.1550 and reviewed by the Clinical Chemistry panel. Devices under PDS reach the market by 510(k); FDA lists no cleared 510(k)s for it.
Definition
To detect specified amniotic fluid proteins in cervicovaginal samples
Classification
| Field | Value |
|---|---|
| Device name | Amniotic Fluid Protein Immunoassay |
| Device class | Class I |
| Regulation | 21 CFR 862.1550 |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Recalls for PDS devices
openFDA lists no recalls for product code PDS.
Frequently asked questions
What is FDA product code PDS?
PDS is the FDA product code for amniotic fluid protein immunoassay. It is a Class I device, regulated under 21 CFR 862.1550 and reviewed by the Clinical Chemistry panel.
What device class is PDS?
Class I, regulation 21 CFR 862.1550. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code PDS
- Run a recall and safety report across every PDS manufacturer
- Watch product code PDS for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
All Clinical Chemistry product codes · FDA product code lookup · 510(k) database search · 510(k) review times