SEA

Test For Detection Of Microorganism(S) Causing Sexually Transmitted Infections Performed By Lay Users

Product code

SEA

Device name

Test For Detection Of Microorganism(S) Causing Sexually Transmitted Infections Performed By Lay Users

Device class

Class 2

21 CFR

21 CFR 866.3386

Medical specialty

Microbiology

Marketing pathway

510(K)

510(k) clearances (last 3 years)

1

Summaries archived here

0 (direct download)

510(k) clearances (all years, FDA)

1 (all years; only the last 3 years are listed here)

FDA classification definition

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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

510(k) clearances, last 3 years (1)

Last three years. Most recent: 2025-03-28.