QIAGEN GmbH is one of 234 FDA 510(k) medical device manufacturers from Germany in the dataset, ranked by real submission volume.
QIAGEN GmbH - FDA 510(k) Cleared Devices
Recent clearances: QIAstat-Dx Gastrointestinal Panel 2, QIAstat-Dx Gastrointestinal Panel 2, QIAstat-Dx Respiratory Panel Plus
13
Total
13
Cleared
0
Denied
QIAGEN GmbH has 13 FDA 510(k) cleared microbiology devices. Based in Hilden, DE.
Latest FDA clearance: Mar 2026. Active since 2012.
Browse the complete list of FDA 510(k) cleared microbiology devices from this manufacturer. Filter by specialty or product code using the sidebar.
Regulatory submissions have been managed by Qiagen, STAT-Dx Life, S.L. (A QIAGEN Company) and QIAGEN Manchester, Ltd..
FDA 510(k) Regulatory Record - QIAGEN GmbH
13 devices
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