Source document or public record
FDA 510(k) K242109 — Xpert® Xpress CoV-2 plus (XPRS-COV2-10)
FDA 510(k) index record K242109. Device: Xpert® Xpress CoV-2 plus (XPRS-COV2-10). Applicant as listed: Cepheid®. Decision date: 2025-01-15.
Source
"device_name": "Xpert® Xpress CoV-2 plus (XPRS-COV2-10)"
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 K242109.
Device name: Xpert® Xpress CoV-2 plus (XPRS-COV2-10). Applicant as listed: Cepheid®.
Decision date: 2025-01-15. Decision wording: Substantially Equivalent.
Product code: QQX. Regulation: 21 CFR 866.3981. 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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