OUYClass II

Trichomonas Vaginalis Nucleic Acid Amplification Test System

21 CFR 866.3860 / Immunology

OUY is the FDA product code for Trichomonas Vaginalis Nucleic Acid Amplification Test System, a class II device type, regulated under 21 CFR 866.3860. FDA's definition for this code reads: "In vitro nucleic acid amplification test for the qualitative detection of ribosomal rna from trichomonas vaginalis as an aid in the diagnosis of trichomoniasis from vaginal, cervical, urogenital and gynecological specimens from symptomatic patients". As of 2026-09-10, FDA records hold 10 510(k) clearances under this code, the most recent dated 2023-11-06, and 4 recalls.

Classification record

Product code: OUY
Device name: Trichomonas Vaginalis Nucleic Acid Amplification Test System
FDA definition: In vitro nucleic acid amplification test for the qualitative detection of ribosomal rna from trichomonas vaginalis as an aid in the diagnosis of trichomoniasis from vaginal, cervical, urogenital and gynecological specimens from symptomatic patients
Regulation: 21 CFR 866.3860
Device class: Class II
Review panel: Immunology
Submission type: 510(k)
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: No
Ingested clearances: 10
Ingested recalls: 4

Clearances, product code OUY

By decision year

10 clearances under product code OUY with a decision year between 2011 and 2023, 2016 the highest year at 3.

Show the numbers

510(k) clearances under FDA product code OUY by decision year
Year	Clearances
2011	1
2013	2
2015	2
2016	3
2019	1
2023	1

Applicants with the most clearances

Product code OUY

Applicants holding the most 510(k) clearances under product code OUY
Applicant	Clearances
Becton Dickinson & Co	3
Cepheid	2
Hologic, Inc.	2
Ortho-Clinical Diagnostics, Inc.	2
Gen-Probe Incorporated	1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 13 companies shown, in name order