FDA product code MZA: Test, Equipment, Automated Bloodborne Pathogen
MZA is the FDA product code for test, equipment, automated bloodborne pathogen. It is a Not classified device, reviewed by the Immunology panel. Devices under MZA reach the market by Contact FDA; FDA lists no cleared 510(k)s for it. FDA has posted 3 recalls for MZA devices, 1 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Test, Equipment, Automated Bloodborne Pathogen |
| Device class | Not classified |
| Review panel | IM — Immunology |
| Medical specialty | Unknown |
| Premarket route | Contact FDA |
Recalls for MZA devices
3 product recalls in 3 recall events; 1 initiated in the last five years and 2 still open. Most recent: 2022-02-03.
| Year | Recalls |
|---|---|
| 2021 | 1 |
| 2022 | 1 |
Frequently asked questions
What is FDA product code MZA?
MZA is the FDA product code for test, equipment, automated bloodborne pathogen. It is a Not classified device, reviewed by the Immunology panel.
What device class is MZA?
Not classified. Typical premarket route: Contact FDA.
Have MZA devices been recalled?
Yes: 3 product recalls across 3 recall events; the most recent began 2022-02-03.
Next steps
- Run an FDA pathway report with predicate devices for product code MZA
- Run a recall and safety report across every MZA manufacturer
- Watch product code MZA 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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