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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

510(k) K151565

Listed No authorization on record

Valid until

Not applicable

No authorization on record

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 7 Oct 2026. What this means

Specification

510(k)

510(k) Number
FDA Product Code
OUY
Device Class
Class II
Regulation
21 CFR Part 866.3860
Advisory Committee
Immunology
FDA Decision
SESE Substantially Equivalent

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