FDA 510(k)

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

Numéro K : K252329 · 2025-10-22

Date de décision2025-10-22

Code produitPCH

Comité consultatifMI

DécisionSubstantially Equivalent

Résumé du dispositif

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 2025-10-22 under 510(k) number K252329. The device is classified under product code PCH. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

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 2025-10-22. The listed applicant is QIAGEN GmbH. The 510(k) number is K252329.

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 2025-10-22, under 510(k) number K252329.

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.

Essais cliniques associés

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Autres dossiers indiquant QIAGEN GmbH en tant que demandeur

K262168QIAstat-Dx BCID GN Plus AMR Panel K254194QIAstat-Dx BCID GPF Plus AMR Panel K254032QIAstat-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

Voir tous les 12 dispositifs →

Dispositifs connexes (Code : PCH)

K253722LIAISON PLEX Gastrointestinal Flex AssayLuminex Corporation K254032QIAstat-Dx Gastrointestinal Panel 2; QIAstat-Dx GI Panel 2 Mini B&V; QIAstat-Dx GI Panel 2 Mini BQIAGEN GmbH K251721Xpert GI PanelCepheid K251868Panther Fusion GI Bacterial AssayHologic K251993Panther Fusion GI Expanded Bacterial AssayHologic, Inc.K250324QIAstat-Dx GI Panel 2 Mini BQIAGEN GmbH

Source officielle

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