FDA product code MTN: Test, Syphilis, Treponemal
MTN is the FDA product code for test, syphilis, treponemal. It is a Not classified device, reviewed by the Hematology panel. Devices under MTN reach the market by Contact FDA; FDA lists no cleared 510(k)s for it. FDA has posted 1 recall for MTN devices, 1 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Test, Syphilis, Treponemal |
| Device class | Not classified |
| Review panel | HE — Hematology |
| Medical specialty | Unknown |
| Premarket route | Contact FDA |
Recalls for MTN devices
1 product recalls in 1 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2025-11-03.
| Year | Recalls |
|---|---|
| 2025 | 1 |
Frequently asked questions
What is FDA product code MTN?
MTN is the FDA product code for test, syphilis, treponemal. It is a Not classified device, reviewed by the Hematology panel.
What device class is MTN?
Not classified. Typical premarket route: Contact FDA.
Have MTN devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2025-11-03.
Next steps
- Run an FDA pathway report with predicate devices for product code MTN
- Run a recall and safety report across every MTN manufacturer
- Watch product code MTN 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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