Trichomonas Vaginalis Nucleic Acid Amplification Test System
Medical specialty
Immunology
Device class
2
Regulation number
866.3860
Review panel
MI
Implant
N
Life sustaining/supporting
N
GMP exempt
N
Third party review
N
Summary malfunction reporting
Eligible
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
Xpert® TV Assay on the Cepheid GeneXpert Instrument Systems (GeneXpert Dx, GeneXpert Infinity-48, GeneXpert Infinity-48s, and GeneXpertInfinity-80 systems), Xpert Vaginal/Endocervical Specimen Collection Kit, and Xpert Urine Specimen Col...