FDA product code MZC: System, Detection, Bacterial, For Platelet Transfusion Products
MZC is the FDA product code for system, detection, bacterial, for platelet transfusion products. It is a Class I device, regulated under 21 CFR 866.2560 and reviewed by the Immunology panel. Devices under MZC reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | System, Detection, Bacterial, For Platelet Transfusion Products |
| Device class | Class I |
| Regulation | 21 CFR 866.2560 |
| Review panel | IM — Immunology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) exempt |
Recalls for MZC devices
openFDA lists no recalls for product code MZC.
Frequently asked questions
What is FDA product code MZC?
MZC is the FDA product code for system, detection, bacterial, for platelet transfusion products. It is a Class I device, regulated under 21 CFR 866.2560 and reviewed by the Immunology panel.
What device class is MZC?
Class I, regulation 21 CFR 866.2560. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code MZC
- Run a recall and safety report across every MZC manufacturer
- Watch product code MZC 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.