FDA product code MTP: Antibody To Htlv-1, Elisa
MTP is the FDA product code for antibody to htlv-1, elisa. It is a Class III device, reviewed by the Hematology panel. Devices under MTP reach the market by Contact FDA; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Antibody To Htlv-1, Elisa |
| Device class | Class III |
| Review panel | HE — Hematology |
| Medical specialty | Unknown |
| Premarket route | Contact FDA |
| Life-sustaining or supporting | Yes |
Recalls for MTP devices
openFDA lists no recalls for product code MTP.
Frequently asked questions
What is FDA product code MTP?
MTP is the FDA product code for antibody to htlv-1, elisa. It is a Class III device, reviewed by the Hematology panel.
What device class is MTP?
Class III. Typical premarket route: Contact FDA.
Next steps
- Run an FDA pathway report with predicate devices for product code MTP
- Run a recall and safety report across every MTP manufacturer
- Watch product code MTP 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.