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FDA 510(k)

QIAstat-Dx Respiratory Panel Plus; QIAstat-Dx Respiratory Panel Mini

K-Number: K250080 · 2025-08-27

ApplicantQIAGEN GmbH
Decision Date2025-08-27
Product CodeQOF
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

QIAstat-Dx Respiratory Panel Plus; QIAstat-Dx Respiratory Panel Mini is a medical device manufactured by QIAGEN GmbH. It received FDA 510(k) clearance on 2025-08-27 under approval number K250080. The device is classified under product code QOF. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the QIAstat-Dx Respiratory Panel Plus; QIAstat-Dx Respiratory Panel Mini?

QIAstat-Dx Respiratory Panel Plus; QIAstat-Dx Respiratory Panel Mini is a medical device that received FDA 510(k) clearance on 2025-08-27. It is manufactured by QIAGEN GmbH. The 510(k) number is K250080.

When was QIAstat-Dx Respiratory Panel Plus; QIAstat-Dx Respiratory Panel Mini approved by the FDA?

QIAstat-Dx Respiratory Panel Plus; QIAstat-Dx Respiratory Panel Mini received FDA 510(k) clearance on 2025-08-27, under approval number K250080.

What company makes QIAstat-Dx Respiratory Panel Plus; QIAstat-Dx Respiratory Panel Mini?

QIAstat-Dx Respiratory Panel Plus; QIAstat-Dx Respiratory Panel Mini is manufactured by QIAGEN GmbH.

What is the FDA product code for QIAstat-Dx Respiratory Panel Plus; QIAstat-Dx Respiratory Panel Mini?

The FDA product code for QIAstat-Dx Respiratory Panel Plus; QIAstat-Dx Respiratory Panel Mini is QOF.

Other Devices by QIAGEN GmbH

K183597QIAstat-Dx Respiratory Panel K242256QIAstat-Dx Meningitis/Encephalitis (ME) Panel K242353QIAstat-Dx Respiratory Panel Mini K220062QIAstat-Dx Gastrointestinal Panel 2 K233100QIAstat-Dx® Respiratory Panel Plus K252329QIAstat-Dx Gastrointestinal Panel 2; QIAstat-Dx GI Panel 2 Mini B&V; QIAstat-Dx GI Panel 2 Mini B

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Related Devices (Code: QOF)

DEN200031BioFire Respiratory Panel 2.1 (RP2.1)Biofire Diagnostics, LLC K231481Xpert Xpress CoV-2/Flu/RSV plusCepheid® K230956BD Respiratory Viral Panel for BD MAX™ System; BD Respiratory Viral Panel-SCV2 for BD MAX™ SystemBd Integrated Diagnostic Solutions / K223591cobas® SARS-CoV-2 & Influenza A/B Nucleic acid test for use on the cobas® Liat® SystemRoche Molecular Systems, Inc. K222736Panther Fusion SARS-CoV-2/Flu A/B/RSV AssayHologic, Inc. K230719BIOFIRE® SPOTFIRE® Respiratory (R) Panel MiniBiofire Diagnostics, LLC

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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