Source document or public record
FDA 510(k) K250080 — QIAstat-Dx Respiratory Panel Plus; QIAstat-Dx Respiratory Panel Mini
FDA 510(k) index record K250080. Device: QIAstat-Dx Respiratory Panel Plus; QIAstat-Dx Respiratory Panel Mini. Applicant as listed: QIAGEN GmbH. Decision date: 2025-08-27.
Source
"device_name": "QIAstat-Dx Respiratory Panel Plus; QIAstat-Dx Respiratory Panel Mini"
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 K250080.
Device name: QIAstat-Dx Respiratory Panel Plus; QIAstat-Dx Respiratory Panel Mini. Applicant as listed: QIAGEN GmbH.
Decision date: 2025-08-27. Decision wording: Substantially Equivalent.
Product code: QOF. 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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