Documento fuente o registro público
FDA 510(k) K222638 — Xpert® Xpress GBS, GeneXpert® Dx System, GeneXpert® Infinity Systems
FDA 510(k) index record K222638. Device: Xpert® Xpress GBS, GeneXpert® Dx System, GeneXpert® Infinity Systems. Applicant as listed: Cepheid. Decision date: 2023-09-27.
Fuente
"device_name": "Xpert® Xpress GBS, GeneXpert® Dx System, GeneXpert® Infinity Systems"
Esta entrada describe lo que cubre el documento; el propio documento es la autoridad. Incluirlo no implica estar de acuerdo con sus conclusiones.
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Automated FDA record verification
2026-10-20
2026-10-20
professional use
FDA 510(k) public index record K222638.
Device name: Xpert® Xpress GBS, GeneXpert® Dx System, GeneXpert® Infinity Systems. Applicant as listed: Cepheid.
Decision date: 2023-09-27. Decision wording: Substantially Equivalent.
Product code: NJR. Regulation: 21 CFR 866.3740. Medical specialty: Microbiology.
This page reproduces regulator index metadata. The applicant field identifies the submitter and is not a manufacturer identity check. Consult the original FDA record for the decision and associated documents; this index does not verify current commercial availability or clinical performance.
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