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..

10
Total
9
Cleared
156d
Avg days
2011
Since
Declining activity - 0 submissions in the last 2 years vs 1 in the prior period

FDA 510(k) Cleared Trichomonas Vaginalis Nucleic Acid Amplification Test System Devices (Product Code OUY)

10 devices
1–10 of 10
Cleared Nov 06, 2023
Aptima Trichomonas vaginalis Assay
K231316
Hologic, Inc.
Microbiology · 182d

About Product Code OUY - Regulatory Context

510(k) Submission Activity

10 total 510(k) submissions under product code OUY since 2011, with 9 receiving FDA clearance (average review time: 156 days).

Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 1 in the prior period.

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