Product code OUY— Immunology
APTIMA TRICHOMONAS VAGINALIS ASSAY
- Classification name
- Trichomonas Vaginalis Nucleic Acid Amplification Test System
- Device class
- Class 2
- Regulation
- 21 CFR 866.3860
- Advisory panel
- Immunology
- Total cleared
- 10
- First cleared
- Most recent
FDA classification 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”
Market context for product code OUY
FDA has cleared devices under product code OUY between 2011 and 2023, filed by 7 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
- 2023
- 2019
- 2016
- 2015
- 2013
- 2011
Top applicants under product code OUY
Recent clearances under product code OUY
- K231316 — Aptima Trichomonas vaginalis Assay
- K182692 — BD MAX CTGCTV2, BD MAX System
- K151589 — BD MAX CT/GC/TV, BD MAX INSTRUMENT
- K161619 — Xpert TV, Xpert Urine Specimen Collection Kit, GeneXpert Dx Systems (GX-I, GX-II, GX-IV, GX-XVI), GeneXpert Infinity-48, Genxpert Infinity-48s and GeneXpert Infinity-80 Systems
- K161182 — Solana Trichomonas Assay
- K151565 — 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 Collection Kit
- K143329 — AmpliVue Trichomonas Assay
- K130268 — BD PROBETEC TRICHOMONAS VAGINALIS (TV) QX AMPLIFIED DNA ASSAY
- K122062 — APTIMA TRICHOMONAS VAGINALIS ASSAY - PANTHER
- DEN110012 — APTIMA TRICHOMONAS VAGINALIS ASSAY
Data sourced from openFDA. This site is unofficial and independent of the FDA.