QIAGEN GmbH - FDA 510(k) Cleared Devices
Recent clearances: QIAstat-Dx BCID GN Plus AMR Panel, QIAstat-Dx BCID GPF Plus AMR Panel, QIAstat-Dx Gastrointestinal Panel 2
15
Total
15
Cleared
0
Denied
FDA 510(k) Regulatory Record - QIAGEN GmbH Microbiology ✕
15 devices
Cleared
Sep 24, 2026
QIAstat-Dx BCID GN Plus AMR Panel
Microbiology
90d
Cleared
Aug 06, 2026
QIAstat-Dx BCID GPF Plus AMR Panel
Microbiology
226d
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