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FDA 510(k)

QIAstat-Dx BCID GN Plus AMR Panel

K-Number: K262168 · 2026-09-24

ApplicantQIAGEN GmbH
Decision Date2026-09-24
Product CodePEN
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

QIAstat-Dx BCID GN Plus AMR Panel is the device name listed in this FDA 510(k) record. The listed applicant is QIAGEN GmbH. It received FDA 510(k) clearance on 2026-09-24 under 510(k) number K262168. The device is classified under product code PEN. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the QIAstat-Dx BCID GN Plus AMR Panel?

QIAstat-Dx BCID GN Plus AMR Panel is a medical device that received FDA 510(k) clearance on 2026-09-24. The listed applicant is QIAGEN GmbH. The 510(k) number is K262168.

When did QIAstat-Dx BCID GN Plus AMR Panel receive FDA 510(k) clearance?

QIAstat-Dx BCID GN Plus AMR Panel received FDA 510(k) clearance on 2026-09-24, under 510(k) number K262168.

Who is the listed applicant for QIAstat-Dx BCID GN Plus AMR Panel?

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 BCID GN Plus AMR Panel?

The FDA product code for QIAstat-Dx BCID GN Plus AMR Panel is PEN.

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: PEN)

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.

K243013LIAISON PLEX Gram-Negative Blood Culture AssayLuminex CorporationK243759BIOFIRE Blood Culture Identification 2 (BCID2) Panel (RFIT-ASY-0147 (30 pack) RFIT-ASY-0148 (6 pack))Biofire Diagnostics, LLCK213236ePlex Blood Culture Identification Gram Negative (BCID-GN) PanelGenmark Diagnostics, IncorporatedK193519BioFire Blood Culture Identification 2 (BCID2) PanelBiofire Diagnostics, LLCK190341iC-GN iC-Cassette for use on the iC-SystemIcubate, Inc.K182619ePlex Blood Culture Identification Gram Negative (BCID-GN) PanelGenmark Diagnostics, Incorporated

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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