K254032
- 510(k) number
- K254032
- Device name
- QIAstat-Dx Gastrointestinal Panel 2; QIAstat-Dx GI Panel 2 Mini B&V; QIAstat-Dx GI Panel 2 Mini B
- Applicant
- QIAGEN GmbH DE
- Product code
- PCH — Gastrointestinal Pathogen Panel Multiplex Nucleic Ac
- Decision date
- 2026-03-09
- Date received
- 2025-12-16
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Microbiology
PDFDownload 510(k) SummaryArchived here · 2.7 MB · U.S. public domain
Also available from FDA: K254032.pdf
Official FDA record: K254032
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.