K151565

Substantially Equivalent

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

Applicant: Cepheid
Product code: OUY
Advisory panel: Immunology
Date received: 2015-06-10
Decision date: 2015-10-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sunnyvale, CA, US

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