Source document or public record
FDA 510(k) K254194 — QIAstat-Dx BCID GPF Plus AMR Panel
FDA 510(k) index record K254194. Device: QIAstat-Dx BCID GPF Plus AMR Panel. Applicant as listed: QIAGEN GmbH. Decision date: 2026-08-06.
Source
"device_name": "QIAstat-Dx BCID GPF Plus AMR Panel"
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 K254194.
Device name: QIAstat-Dx BCID GPF Plus AMR Panel. Applicant as listed: QIAGEN GmbH.
Decision date: 2026-08-06. Decision wording: Substantially Equivalent.
Product code: PAM. Regulation: 21 CFR 866.3365. 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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