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Trichomonas Vaginalis Nucleic Acid Amplification Test System

FDA product code OUY · 7 cleared devices

Class 2 Immunology
Regulation
21 CFR 866.3860
Review panel
MI
Implant
No
Life sustaining
No
Third party review
No
GMP exempt
No
Clearance span
2013-01-09 – 2023-11-06

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

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