FDA Device Intelligence
Home › Device types › MTN

Test, Syphilis, Treponemal

FDA product code MTN · Class N · Unknown

4
Registered devices
104
Adverse events
1
Recalls
0
510(k) clearances

Devices with this code

Spirochete — BIOCARE MEDICAL LLCSpirochete — BIOCARE MEDICAL LLCSpirochete — BIOCARE MEDICAL LLCSpirochete — BIOCARE MEDICAL LLC

Recent recalls

DateFirmReason
2025-11-03GET TESTED INTERNATIONAL ABDistribution without premarket approval/clearance.

Query this across every FDA database — by API.

Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

Get your free API keyRead the docs
Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.