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

Trichomonas Vaginalis Nucleic Acid Amplification Test System

CEPHEID

The following data is part of a premarket notification filed by Cepheid with the FDA for 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.

Pre-market Notification Details

• Device ID: K151565
• 510k Number: K151565
• Device Name: 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
• Classification: Trichomonas Vaginalis Nucleic Acid Amplification Test System
• Applicant: CEPHEID 904 CARIBBEAN DRIVE Sunnyvale, CA 94089
• Contact: Kerry J. Flom
• Correspondent: Scott A. Campbell; CEPHEID 904 CARIBBEAN DRIVE Sunnyvale, CA 94089
• Product Code: OUY
• CFR Regulation Number: 866.3860 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2015-06-10
• Decision Date: 2015-10-16
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
07332940001001	K151565	000