OUY · Class II · 21 CFR 866.3860

FDA Product Code OUY: Trichomonas Vaginalis Nucleic Acid Amplification Test System

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

Leading manufacturers include Hologic, Inc..

1
Total
1
Cleared
182d
Avg days
2023
Since

List of Trichomonas Vaginalis Nucleic Acid Amplification Test System devices cleared through 510(k)

1 devices
1–1 of 1

How to use this database

This page lists all FDA 510(k) submissions for Trichomonas Vaginalis Nucleic Acid Amplification Test System devices (product code OUY). Click any device to view full submission details, including the decision date, manufacturer information, predicate device, and a link to the official FDA record.

These devices fall under the Microbiology FDA review panel. Browse all Microbiology devices →