FDA product code MVC: System, Test, Her-2/Neu, Ihc
MVC is the FDA product code for system, test, her-2/neu, ihc. It is a Class III device, reviewed by the Pathology panel. Devices under MVC reach the market by PMA; FDA lists no cleared 510(k)s for it. 4 PMA applications cite this product code. FDA has posted 8 recalls for MVC devices.
Classification
| Field | Value |
|---|---|
| Device name | System, Test, Her-2/Neu, Ihc |
| Device class | Class III |
| Review panel | PA — Pathology |
| Medical specialty | Unknown |
| Premarket route | PMA |
Recalls for MVC devices
8 product recalls in 4 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2014-07-01.
Frequently asked questions
What is FDA product code MVC?
MVC is the FDA product code for system, test, her-2/neu, ihc. It is a Class III device, reviewed by the Pathology panel.
What device class is MVC?
Class III. Typical premarket route: PMA.
Have MVC devices been recalled?
Yes: 8 product recalls across 4 recall events; the most recent began 2014-07-01.
Next steps
- Run an FDA pathway report with predicate devices for product code MVC
- Run a recall and safety report across every MVC manufacturer
- Watch product code MVC 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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