FDA product code MYP: Test, Platelet Antibody
MYP is the FDA product code for test, platelet antibody. It is a Class II device, reviewed by the Hematology panel. Devices under MYP reach the market by 510(k); FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Test, Platelet Antibody |
| Device class | Class II |
| Review panel | HE — Hematology |
| Medical specialty | Unknown |
| Premarket route | 510(k) |
Recalls for MYP devices
openFDA lists no recalls for product code MYP.
Frequently asked questions
What is FDA product code MYP?
MYP is the FDA product code for test, platelet antibody. It is a Class II device, reviewed by the Hematology panel.
What device class is MYP?
Class II. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code MYP
- Run a recall and safety report across every MYP manufacturer
- Watch product code MYP 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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