MTNNot classified

Test, Syphilis, Treponemal

Unknown

MTN is the FDA product code for Test, Syphilis, Treponemal. As of 2026-09-10, FDA records hold no 510(k) clearances under this code and one recall.

Classification record

Product code: MTN
Device name: Test, Syphilis, Treponemal
Device class: Not classified
Review panel: Unknown
Submission type: Contact ODE
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: No
Ingested clearances: 0
Ingested recalls: 1

Companies listing this code with FDA

Companies whose registered establishments list this code

Recent clearances

Product code MTN

FDA records hold no clearances under product code MTN.

Recent recalls

Product code MTN

Z-0751-2026Class IIDistribution without premarket approval/clearance.Get Tested International Ab / initiated 2025-11-03 / 528 units

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device classification database, ingested from openFDA. The definition, regulation number, device class and review panel are FDA’s own fields, reproduced without editing.

MDM adds the counts: clearances by decision year, the applicants holding the most clearances under this code, recalls that name it, and the registered establishments that list it. Every count is computed from ingested records only.

Data as of 2026-10-05, the FDA export date for this dataset. Page last changed 2026-09-05. View this product code on fda.gov (opens on fda.gov)