FDA 510(k)

QIAstat-Dx Gastrointestinal Panel 2; QIAstat-Dx GI Panel 2 Mini B&V; QIAstat-Dx GI Panel 2 Mini B

N.º K: K254032 · 2026-03-09

Fecha de decisión2026-03-09

Código de productoPCH

Comité asesorMI

DecisiónSubstantially Equivalent

Resumen del dispositivo

QIAstat-Dx Gastrointestinal Panel 2; QIAstat-Dx GI Panel 2 Mini B&V; QIAstat-Dx GI Panel 2 Mini B is the device name listed in this FDA 510(k) record. The listed applicant is QIAGEN GmbH. It received FDA 510(k) clearance on 2026-03-09 under 510(k) number K254032. The device is classified under product code PCH. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the QIAstat-Dx Gastrointestinal Panel 2; QIAstat-Dx GI Panel 2 Mini B&V; QIAstat-Dx GI Panel 2 Mini B?

QIAstat-Dx Gastrointestinal Panel 2; QIAstat-Dx GI Panel 2 Mini B&V; QIAstat-Dx GI Panel 2 Mini B is a medical device that received FDA 510(k) clearance on 2026-03-09. The listed applicant is QIAGEN GmbH. The 510(k) number is K254032.

When did QIAstat-Dx Gastrointestinal Panel 2; QIAstat-Dx GI Panel 2 Mini B&V; QIAstat-Dx GI Panel 2 Mini B receive FDA 510(k) clearance?

QIAstat-Dx Gastrointestinal Panel 2; QIAstat-Dx GI Panel 2 Mini B&V; QIAstat-Dx GI Panel 2 Mini B received FDA 510(k) clearance on 2026-03-09, under 510(k) number K254032.

Who is the listed applicant for QIAstat-Dx Gastrointestinal Panel 2; QIAstat-Dx GI Panel 2 Mini B&V; QIAstat-Dx GI Panel 2 Mini B?

The FDA 510(k) record lists QIAGEN GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for QIAstat-Dx Gastrointestinal Panel 2; QIAstat-Dx GI Panel 2 Mini B&V; QIAstat-Dx GI Panel 2 Mini B?

The FDA product code for QIAstat-Dx Gastrointestinal Panel 2; QIAstat-Dx GI Panel 2 Mini B&V; QIAstat-Dx GI Panel 2 Mini B is PCH.

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Otros registros que enlistan a QIAGEN GmbH como solicitante

K262168QIAstat-Dx BCID GN Plus AMR Panel K254194QIAstat-Dx BCID GPF Plus AMR Panel K252329QIAstat-Dx Gastrointestinal Panel 2; QIAstat-Dx GI Panel 2 Mini B&V; QIAstat-Dx GI Panel 2 Mini B K250080QIAstat-Dx Respiratory Panel Plus; QIAstat-Dx Respiratory Panel Mini K250324QIAstat-Dx GI Panel 2 Mini B K243813QIAstat-Dx GI Panel 2 Mini B&V

Ver todos los 12 dispositivos →

Dispositivos relacionados (Código: PCH)

K253722LIAISON PLEX Gastrointestinal Flex AssayLuminex Corporation K251721Xpert GI PanelCepheid K252329QIAstat-Dx Gastrointestinal Panel 2; QIAstat-Dx GI Panel 2 Mini B&V; QIAstat-Dx GI Panel 2 Mini BQIAGEN GmbH K251993Panther Fusion GI Expanded Bacterial AssayHologic, Inc.K251868Panther Fusion GI Bacterial AssayHologic K250324QIAstat-Dx GI Panel 2 Mini BQIAGEN GmbH

Fuente oficial

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