QIAstat-Dx Gastrointestinal Panel 2; QIAstat-Dx GI Panel 2 Mini B&V— 510(k) K254032

Name: FDA 510(k) clearance K254032
Creator: U.S. Food and Drug Administration
Published: 2026-03-09

Substantially Equivalent

QIAGEN 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.

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: Code PCH
Device class: Class 2
Regulation: 21 CFR 866.3990
Advisory panel: Microbiology
Date received: 2025-12-16
Decision date: 2026-03-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hilden, DE

Download summary PDF View on FDA.gov ↗

Recent devices under product code PCH

view all

K253722 — LIAISON PLEX Gastrointestinal Flex Assay2026-05-19
K251721 — Xpert GI Panel2026-01-16
K252329 — QIAstat-Dx Gastrointestinal Panel 2; QIAstat-Dx GI Panel 2 Mini B&V2025-10-22
K251868 — Panther Fusion GI Bacterial Assay2025-09-25
K251993 — Panther Fusion GI Expanded Bacterial Assay2025-09-25

More clearances from QIAGEN GmbH

view all

K254194 — QIAstat-Dx BCID GPF Plus AMR Panel2026-08-06
K250080 — QIAstat-Dx Respiratory Panel Plus; QIAstat-Dx Respiratory Panel Mini2025-08-27
K250324 — QIAstat-Dx GI Panel 2 Mini B2025-02-28
K243813 — QIAstat-Dx GI Panel 2 Mini B&V2025-01-08
K242256 — QIAstat-Dx Meningitis/Encephalitis (ME) Panel2024-10-29

Data sourced from openFDA. This site is unofficial and independent of the FDA.