DeviceClearance

Product code SEA— Microbiology

Visby Medical Women's Sexual Health Test

Classification name
Test For Detection Of Microorganism(S) Causing Sexually Transmitted Infections Performed By Lay Users
Device class
Class 2
Regulation
21 CFR 866.3386
Advisory panel
Microbiology
Total cleared
1
First cleared
Most recent

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.”

— U.S. Food and Drug Administration, device classification record for product code SEA under 21 CFR 866.3386, via openFDA

Market context for product code SEA

FDA has cleared 1 device under product code SEA, all in 2025, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Top applicants under product code SEA

Recent clearances under product code SEA

Data sourced from openFDA. This site is unofficial and independent of the FDA.