SEA · Class II · 21 CFR 866.3386

FDA Product Code SEA: Test For Detection Of Microorganism(s) Causing Sexually Transmitted Infections Performed By Lay Users

This Device Is An In Vitro Diagnostic Device For The Detection And/or Differentiation Of Nucleic Acids From Non-viral Microorganism(s) Causing Sexually Transmitted Infections In Clinical Specimens For Use In Home Settings, Or Similar Environments. The Test Is Intended For Prescription Or Over-the-counter Use.

Leading manufacturers include Visby Medical, Inc..

1
Total
0
Cleared
319d
Avg days
2025
Since
Growing category - 1 submissions in the last 2 years vs 0 in the prior period

FDA 510(k) Cleared Test For Detection Of Microorganism(s) Causing Sexually Transmitted Infections Performed By Lay Users Devices (Product Code SEA)

1 devices
1–1 of 1
Not Cleared Mar 28, 2025
Visby Medical Women's Sexual Health Test
DEN240020
Visby Medical, Inc.
Microbiology · 319d

About Product Code SEA - Regulatory Context

510(k) Submission Activity

1 total 510(k) submissions under product code SEA since 2025, with 0 receiving FDA clearance (average review time: 319 days).

Submission volume has increased in recent years - 1 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.

SEA devices are reviewed by the Microbiology panel. Browse all Microbiology devices →