FDA product code MVZ: System, Test, Home, Hiv-1
MVZ is the FDA product code for system, test, home, hiv-1. It is a Class III device, reviewed by the Hematology panel. Devices under MVZ reach the market by PMA; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | System, Test, Home, Hiv-1 |
| Device class | Class III |
| Review panel | HE — Hematology |
| Medical specialty | Unknown |
| Premarket route | PMA |
Recalls for MVZ devices
openFDA lists no recalls for product code MVZ.
HCPCS codes with matching descriptors
Text match between the FDA device name and CMS descriptors, not an official crosswalk:
- G0400 — Home sleep test (hst) with type iv portable monitor, unattended; minimum of 3 channels
Frequently asked questions
What is FDA product code MVZ?
MVZ is the FDA product code for system, test, home, hiv-1. It is a Class III device, reviewed by the Hematology panel.
What device class is MVZ?
Class III. Typical premarket route: PMA.
Next steps
- Run an FDA pathway report with predicate devices for product code MVZ
- Run a recall and safety report across every MVZ manufacturer
- Watch product code MVZ 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.