Xpert MTB/RIF Assay, GeneXpert Dx, GeneXpert Infinity-48, GeneXpert Infinity-48s, GeneXpert Infinity-80

K143302 is the FDA 510(k) clearance record for Xpert MTB/RIF Assay, GeneXpert Dx, GeneXpert Infinity-48, GeneXpert Infinity-48s, GeneXpert Infinity-80, a class II device, cleared for Cepheid on 2015-02-12 under FDA product code PEU (System, Nucleic Acid-Based, Mycobacterium Tuberculosis Complex, Resistance Marker, Direct Specimen). FDA's definition for product code PEU reads: "The [test] is intended for use with specimens from patients for whom there is clinical suspicion of tuberculosis (TB) and who have received no antituberculosis therapy, or less than 3 days of therapy. This [test] is intended as an aid in...". FDA records list 62 510(k) clearances for Cepheid, from 2006-07-25 to 2026-08-07. As of 2026-09-10, FDA records show one recall naming K143302.