QIAGEN GmbH is one of 467 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 BCID GN Plus AMR Panel, QIAstat-Dx BCID GPF Plus AMR Panel, QIAstat-Dx Gastrointestinal Panel 2
15
Total
15
Cleared
0
Denied
QIAGEN GmbH has 15 FDA 510(k) cleared microbiology devices. Based in Hilden, DE.
Latest FDA clearance: Sep 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
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