Trichomonas Vaginalis Nucleic Acid Amplification Test System
OUY · Class II — Moderate Risk (510(k) clearance required) · Immunology · 21 CFR 866.3860
Classification
FDA Product Code
OUY
Device class
Class II — Moderate Risk (510(k) clearance required)
Regulation
21 CFR 866.3860
Review panel
MI
Medical specialty
Immunology
Submission type
1
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
N
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