FDA product code MYZ: Kit, Test (Donors), For Bloodborne Pathogen
MYZ is the FDA product code for kit, test (donors), for bloodborne pathogen. It is a Class II device, reviewed by the Immunology panel. Devices under MYZ reach the market by 510(k); FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Kit, Test (Donors), For Bloodborne Pathogen |
| Device class | Class II |
| Review panel | IM — Immunology |
| Medical specialty | Unknown |
| Premarket route | 510(k) |
Recalls for MYZ devices
openFDA lists no recalls for product code MYZ.
Frequently asked questions
What is FDA product code MYZ?
MYZ is the FDA product code for kit, test (donors), for bloodborne pathogen. It is a Class II device, reviewed by the Immunology panel.
What device class is MYZ?
Class II. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code MYZ
- Run a recall and safety report across every MYZ manufacturer
- Watch product code MYZ 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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