510(k) K250080

Device: QIAstat-Dx Respiratory Panel Plus; QIAstat-Dx Respiratory Panel Mini
Applicant: QIAGEN GmbH
510(k) number: K250080
Product code: QOF
Decision: Substantially Equivalent (SESE)
Decision date: 2025-08-27
Date received: 2025-01-13
Regulation: 866.3981
Classification name: Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents
Medical specialty: Microbiology
Review panel: Microbiology
Device class: 2
Clearance type: Traditional
Statement or summary: Summary
Third party reviewed: N

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