OUY

Trichomonas Vaginalis Nucleic Acid Amplification Test System

Product code

OUY

Device name

Trichomonas Vaginalis Nucleic Acid Amplification Test System

Device class

Class 2

21 CFR

21 CFR 866.3860

Medical specialty

Immunology

Marketing pathway

510(K)

510(k) clearances (last 3 years)

1

Summaries archived here

1 (direct download)

510(k) clearances (all years, FDA)

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

FDA classification 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

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: 2023-11-06.

1 summaries are archived here for direct download.