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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 the device name listed in this FDA 510(k) record. The listed applicant is QIAGEN GmbH. It received FDA 510(k) clearance on 2025-08-27 under 510(k) 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. The listed applicant is QIAGEN GmbH. The 510(k) number is K250080.

When did QIAstat-Dx Respiratory Panel Plus; QIAstat-Dx Respiratory Panel Mini receive FDA 510(k) clearance?

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

Who is the listed applicant for QIAstat-Dx Respiratory Panel Plus; QIAstat-Dx Respiratory Panel Mini?

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 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 records listing QIAGEN GmbH as applicant

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Related Devices (Code: QOF)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252932Fast PCR Mini Respiratory PanelAutonomous Medical Devices IncorporatedK252269FINDER Flu A&B/SARS-CoV-2 TestBaebies, Inc.K251742VELO Respiratory TestLex Diagnostics LimitedK251978LIAISON NES FLU A/B, RSV & COVID-19Diasorin Molecular, LLCK252387Simplexa™ COVID-19/ Flu A/B & RSV Direct (MOL4450); Simplexa™ COVID-19/ Flu A/B & RSV Positive Control Pack (MOL4460)Diasorin Molecular, LLCK243544BIOFIRE SPOTFIRE Respiratory/Sore Throat 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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