QIAstat-Dx Gastrointestinal Panel 2; QIAstat-Dx GI Panel 2 Mini B&V— 510(k) K254032
Substantially EquivalentQIAGEN GmbH
FDA 510(k) clearance K254032 for QIAstat-Dx Gastrointestinal Panel 2; QIAstat-Dx GI Panel 2 Mini B&V, Substantially Equivalent on 2026-03-09. Applicant: QIAGEN GmbH. Device class: 2.
Summary
QIAGEN's record covers three panels: QIAstat-Dx Gastrointestinal Panel 2, QIAstat-Dx GI Panel 2 Mini B&V and QIAstat-Dx GI Panel 2 Mini B. They're filed under PCH, multiplex nucleic acid-based gastrointestinal pathogen panel assay systems.
Class II, 21 CFR 866.3990. It was a Traditional 510(k), and Microbiology is both the classification panel and the review panel.
QIAGEN filed from Hilden, Germany. The decision came 83 calendar days after FDA received it (December 16, 2025 to March 9, 2026).
Clearance details
- Device name as filed
- QIAstat-Dx Gastrointestinal Panel 2; QIAstat-Dx GI Panel 2 Mini B&V; QIAstat-Dx GI Panel 2 Mini B
- Applicant
- QIAGEN GmbH
- Product code
- Product code PCH
- Device class
- Class 2
- Regulation
- 21 CFR 866.3990
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Hilden, DE
Recent devices under product code PCH
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