FDA product code MYX: System, Blood Collection, Vacuum-Assisted, Automated
MYX is the FDA product code for system, blood collection, vacuum-assisted, automated. It is a Class I device, regulated under 21 CFR 864.9125 and reviewed by the Hematology panel. Devices under MYX reach the market by 510(k); FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | System, Blood Collection, Vacuum-Assisted, Automated |
| Device class | Class I |
| Regulation | 21 CFR 864.9125 |
| Review panel | HE — Hematology |
| Medical specialty | Hematology |
| Premarket route | 510(k) |
Recalls for MYX devices
openFDA lists no recalls for product code MYX.
Frequently asked questions
What is FDA product code MYX?
MYX is the FDA product code for system, blood collection, vacuum-assisted, automated. It is a Class I device, regulated under 21 CFR 864.9125 and reviewed by the Hematology panel.
What device class is MYX?
Class I, regulation 21 CFR 864.9125. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code MYX
- Run a recall and safety report across every MYX manufacturer
- Watch product code MYX 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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