FDA product code MTS: Vials, Challenge, Endotoxin
MTS is the FDA product code for vials, challenge, endotoxin. It is a Not classified device, reviewed by the Hematology panel. Devices under MTS reach the market by Contact FDA; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Vials, Challenge, Endotoxin |
| Device class | Not classified |
| Review panel | HE — Hematology |
| Medical specialty | Unknown |
| Premarket route | Contact FDA |
Recalls for MTS devices
openFDA lists no recalls for product code MTS.
Frequently asked questions
What is FDA product code MTS?
MTS is the FDA product code for vials, challenge, endotoxin. It is a Not classified device, reviewed by the Hematology panel.
What device class is MTS?
Not classified. Typical premarket route: Contact FDA.
Next steps
- Run an FDA pathway report with predicate devices for product code MTS
- Run a recall and safety report across every MTS manufacturer
- Watch product code MTS 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.