FDA product code OUY

Trichomonas Vaginalis Nucleic Acid Amplification Test System

Immunology·Class 2·21 CFR 866.3860
US regulatory classifications
US Product Code (FDA)
OUY
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US Risk Class (FDA)
Class 2
US Regulation (CFR)
21 CFR 866.3860
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Medical specialty
Immunology
Device characteristics
GMP exempt
No
Implantable
No
Life-sustaining
No
Third party review
Not 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

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About this record

Trichomonas Vaginalis Nucleic Acid Amplification Test System is a medical device type in the Immunology specialty. This page includes real-world medical device registration data worldwide for this device type, with registrations from US FDA, Brazil ANVISA, and other global markets.

View regulatory classifications, recent 510(k) clearances, active device registrations, and similar products registered globally under this device category. Pure Global AI's free directory provides comprehensive worldwide registration intelligence across 7,000+ medical device types and 21 specialties.