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FDA 510(k)

QIAstat-Dx Gastrointestinal Panel 2

K-Number: K220062 · 2024-05-31

ApplicantQIAGEN GmbH
Decision Date2024-05-31
Product CodePCH
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

QIAstat-Dx Gastrointestinal Panel 2 is the device name listed in this FDA 510(k) record. The listed applicant is QIAGEN GmbH. It received FDA 510(k) clearance on 2024-05-31 under 510(k) number K220062. The device is classified under product code PCH. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the QIAstat-Dx Gastrointestinal Panel 2?

QIAstat-Dx Gastrointestinal Panel 2 is a medical device that received FDA 510(k) clearance on 2024-05-31. The listed applicant is QIAGEN GmbH. The 510(k) number is K220062.

When did QIAstat-Dx Gastrointestinal Panel 2 receive FDA 510(k) clearance?

QIAstat-Dx Gastrointestinal Panel 2 received FDA 510(k) clearance on 2024-05-31, under 510(k) number K220062.

Who is the listed applicant for QIAstat-Dx Gastrointestinal Panel 2?

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?

The FDA product code for QIAstat-Dx Gastrointestinal Panel 2 is PCH.

Other records listing QIAGEN GmbH as applicant

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.

K254194QIAstat-Dx BCID GPF Plus AMR PanelPMA P180043Somatic gene mutation detection systemK254032QIAstat-Dx Gastrointestinal Panel 2; QIAstat-Dx GI Panel 2 Mini B&V; QIAstat-Dx GI Panel 2 Mini BPMA P010033TEST, IMMUNITY, CELL MEDIATED, MYCOBACTERIUM TUBERCULOSISPMA P190001Somatic gene mutation detection systemK252329QIAstat-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: PCH)

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.

K253722LIAISON PLEX Gastrointestinal Flex AssayLuminex CorporationK254032QIAstat-Dx Gastrointestinal Panel 2; QIAstat-Dx GI Panel 2 Mini B&V; QIAstat-Dx GI Panel 2 Mini BQIAGEN GmbHK251721Xpert GI PanelCepheidK252329QIAstat-Dx Gastrointestinal Panel 2; QIAstat-Dx GI Panel 2 Mini B&V; QIAstat-Dx GI Panel 2 Mini BQIAGEN GmbHK251993Panther Fusion GI Expanded Bacterial AssayHologic, Inc.K251868Panther Fusion GI Bacterial AssayHologic

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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