FDA product code PDX: Flow Cytometry Calibrator
PDX is the FDA product code for flow cytometry calibrator. It is a Class II device, regulated under 21 CFR 864.5220 and reviewed by the Immunology panel. Devices under PDX reach the market by 510(k); FDA lists no cleared 510(k)s for it.
Definition
Flow cytometer calibrators are polystyrene or other particles whose defined characteristics (e.g. number, size, scatter or fluorescence intensity) is used to standardize instrumentation or to quantify other particles or analytes measured by flow cytometers.
Classification
| Field | Value |
|---|---|
| Device name | Flow Cytometry Calibrator |
| Device class | Class II |
| Regulation | 21 CFR 864.5220 |
| Review panel | IM — Immunology |
| Medical specialty | Hematology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Recalls for PDX devices
openFDA lists no recalls for product code PDX.
Frequently asked questions
What is FDA product code PDX?
PDX is the FDA product code for flow cytometry calibrator. It is a Class II device, regulated under 21 CFR 864.5220 and reviewed by the Immunology panel.
What device class is PDX?
Class II, regulation 21 CFR 864.5220. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code PDX
- Run a recall and safety report across every PDX manufacturer
- Watch product code PDX 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.
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