FDA product code MVU: Reagents, Specific, Analyte
MVU is the FDA product code for reagents, specific, analyte. It is a Class I device, regulated under 21 CFR 864.4020 and reviewed by the Hematology panel. Devices under MVU reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it. FDA has posted 43 recalls for MVU devices, 11 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Reagents, Specific, Analyte |
| Device class | Class I |
| Regulation | 21 CFR 864.4020 |
| Review panel | HE — Hematology |
| Medical specialty | Pathology |
| Premarket route | 510(k) exempt |
Recalls for MVU devices
43 product recalls in 35 recall events; 11 initiated in the last five years and 9 still open. Most recent: 2025-11-03.
| Year | Recalls |
|---|---|
| 2017 | 5 |
| 2019 | 2 |
| 2020 | 3 |
| 2021 | 6 |
| 2022 | 5 |
| 2023 | 3 |
| 2024 | 2 |
| 2025 | 1 |
Frequently asked questions
What is FDA product code MVU?
MVU is the FDA product code for reagents, specific, analyte. It is a Class I device, regulated under 21 CFR 864.4020 and reviewed by the Hematology panel.
What device class is MVU?
Class I, regulation 21 CFR 864.4020. Typical premarket route: 510(k) exempt.
Have MVU devices been recalled?
Yes: 43 product recalls across 35 recall events; the most recent began 2025-11-03.
Next steps
- Run an FDA pathway report with predicate devices for product code MVU
- Run a recall and safety report across every MVU manufacturer
- Watch product code MVU 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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