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FDA 510(k)

QIAstat-Dx Respiratory Panel

K-Number: K183597 · 2019-05-18

ApplicantQIAGEN GmbH
Decision Date2019-05-18
Product CodeOCC
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

QIAstat-Dx Respiratory 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 2019-05-18 under 510(k) number K183597. The device is classified under product code OCC. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the QIAstat-Dx Respiratory Panel?

QIAstat-Dx Respiratory Panel is a medical device that received FDA 510(k) clearance on 2019-05-18. The listed applicant is QIAGEN GmbH. The 510(k) number is K183597.

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

QIAstat-Dx Respiratory Panel received FDA 510(k) clearance on 2019-05-18, under 510(k) number K183597.

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

The FDA product code for QIAstat-Dx Respiratory Panel is OCC.

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: OCC)

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.

K254139BioCode® Respiratory Pathogen Panel (RPP)Applied BioCode, Inc.K242613NxTAG® Respiratory Pathogen PanelLuminex Molecular Diagnostics, Inc.K232775ID NOW Influenza A & B 2Abbott Diagnostics Scarborough, Inc.K231017Panther Fusion AdV/hMPV/RV AssayHologic, Inc.K213822cobas Influenza A/B & RSV nucleic acid test for use on the cobas Liat SystemRoche Molecular Systems, Inc.K210234cobas Influenza A/B & RSV Nucleic acid test for use on the cobas Liat SystemRoche Molecular Systems, Inc.

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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