Source document or public record
FDA 510(k) K203429 — Xpert GBS LB XC, GeneXpert Dx System, GeneXpert Infinity System
FDA 510(k) index record K203429. Device: Xpert GBS LB XC, GeneXpert Dx System, GeneXpert Infinity System. Applicant as listed: Cepheid. Decision date: 2022-05-09.
Source
"device_name": "Xpert GBS LB XC, GeneXpert Dx System, GeneXpert Infinity System"
This entry describes what the document covers; the document itself is the authority. Listing it is not agreement with its conclusions.
Review and references
Automated FDA record verification
2026-10-20
2026-10-20
professional use
FDA 510(k) public index record K203429.
Device name: Xpert GBS LB XC, GeneXpert Dx System, GeneXpert Infinity System. Applicant as listed: Cepheid.
Decision date: 2022-05-09. 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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