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10 FDA 510(k) clearances · Product code

FDA profile

Official device name

Trichomonas Vaginalis Nucleic Acid Amplification Test System

Device class

Class II (moderate risk)

Regulation

21 CFR 866.3860

Medical specialty

Immunology

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

Adverse events (MAUDE)

2022: 16
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.

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