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510(k) 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 by Cepheid — Product Code OUY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 16, 2015
Date Received
June 10, 2015
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Trichomonas Vaginalis Nucleic Acid Amplification Test System
Device Class
Class II
Regulation Number
866.3860
Review Panel
MI
Submission Type

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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Other clearances for product code OUY

  • K231316 — Aptima Trichomonas vaginalis Assay (November 6, 2023)
  • K182692 — BD MAX CTGCTV2, BD MAX System (January 8, 2019)
  • K151589 — BD MAX CT/GC/TV, BD MAX INSTRUMENT (September 6, 2016)
  • K161619 — Xpert TV, Xpert Urine Specimen Collection Kit, GeneXpert Dx Systems (GX-I, GX-II (August 29, 2016)
  • K161182 — Solana Trichomonas Assay (August 15, 2016)
  • K143329 — AmpliVue Trichomonas Assay (March 17, 2015)
  • K130268 — BD PROBETEC TRICHOMONAS VAGINALIS (TV) QX AMPLIFIED DNA ASSAY (August 23, 2013)
  • K122062 — APTIMA TRICHOMONAS VAGINALIS ASSAY - PANTHER (January 9, 2013)
  • DEN110012 — APTIMA TRICHOMONAS VAGINALIS ASSAY (April 19, 2011)