FDA product code MTI: Kit, Cell Screening, Fetal
MTI is the FDA product code for kit, cell screening, fetal. It is a Not classified device, reviewed by the Pathology panel. Devices under MTI reach the market by Contact FDA; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Kit, Cell Screening, Fetal |
| Device class | Not classified |
| Review panel | PA — Pathology |
| Medical specialty | Unknown |
| Premarket route | Contact FDA |
Recalls for MTI devices
openFDA lists no recalls for product code MTI.
Frequently asked questions
What is FDA product code MTI?
MTI is the FDA product code for kit, cell screening, fetal. It is a Not classified device, reviewed by the Pathology panel.
What device class is MTI?
Not classified. Typical premarket route: Contact FDA.
Next steps
- Run an FDA pathway report with predicate devices for product code MTI
- Run a recall and safety report across every MTI manufacturer
- Watch product code MTI 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.