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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System
510(k) Number K254032
Device Name QIAstat-Dx Gastrointestinal Panel 2; QIAstat-Dx GI Panel 2 Mini B&V; QIAstat-Dx GI Panel 2 Mini B
Applicant
QIAGEN GmbH
Qiagen Strasse 1
Hilden,  DE 40724
Applicant Contact Kristen Kanack
Correspondent
STAT-Dx Life, S.L. (A QIAGEN Company)
Carrer Baldiri Reixac, 4
Barcelona,  ES 08028
Correspondent Contact Sonia Pablo
Regulation Number866.3990
Classification Product Code
PCH  
Date Received12/16/2025
Decision Date 03/09/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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