Medical Device Manufacturer · DE , Hilden

QIAGEN GmbH - FDA 510(k) Cleared Devices

13 submissions · 13 cleared · Since 2012

Recent clearances: QIAstat-Dx Gastrointestinal Panel 2, QIAstat-Dx Gastrointestinal Panel 2, QIAstat-Dx Respiratory Panel Plus

13

Total

13

Cleared

0

Denied

FDA 510(k) Regulatory Record - QIAGEN GmbH Microbiology ✕

13 devices

1-13 of 13

Cleared Mar 09, 2026

QIAstat-Dx Gastrointestinal Panel 2

Microbiology · 83d

Cleared Oct 22, 2025

QIAstat-Dx Gastrointestinal Panel 2

Microbiology · 89d

Cleared Aug 27, 2025

QIAstat-Dx Respiratory Panel Plus

Microbiology · 226d

Cleared Feb 28, 2025

QIAstat-Dx GI Panel 2 Mini B

Microbiology · 23d

Cleared Jan 08, 2025

QIAstat-Dx GI Panel 2 Mini B&V

Microbiology · 28d

Cleared Oct 29, 2024

QIAstat-Dx Meningitis/Encephalitis (ME) Panel

Microbiology · 90d

Cleared Oct 25, 2024

QIAstat-Dx Respiratory Panel Mini

Microbiology · 78d

Cleared May 31, 2024

QIAstat-Dx Gastrointestinal Panel 2

Microbiology · 872d

Cleared May 10, 2024

QIAstat-Dx® Respiratory Panel Plus

Microbiology · 227d

Cleared May 18, 2019

QIAstat-Dx Respiratory Panel

Microbiology · 148d

Cleared Apr 04, 2014

ARTUS C. DIFFICILE QS-RGQ MDX KIT

Microbiology · 102d

Cleared Feb 06, 2012

ROTOR-GENE Q MDX

Microbiology · 88d

Cleared Feb 06, 2012

ARTUS INFL A/B RG RT-PCR KIT

Microbiology · 88d