Medical Device Manufacturer · DE , Hilden

QIAGEN GmbH

13 submissions · 13 cleared · Since 2012
13
Total
13
Cleared
0
Denied

QIAGEN GmbH — FDA 510(k) Submissions

QIAGEN GmbH has submitted 13 FDA 510(k) premarket notifications since 2012, of which 13 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-based Assay System, Multi-target Respiratory Specimen Nucleic Acid Test Including Sars-cov-2 And Other Microbial Agents, Respiratory Virus Panel Nucleic Acid Assay System, Meningitis/encephalitis Pathogen Multiplex Nucleic Acid Detection System, Real Time Nucleic Acid Amplification System . Use the specialty filter in the sidebar to narrow results.

13 devices
1–13 of 13
QIAstat-Dx Gastrointestinal Panel 2; QIAstat-Dx GI Panel 2 Mini B&V; QIAstat-Dx GI Panel 2 Mini B
K254032 · PCH Gastrointestinal Pathogen... · Microbiology
Mar 2026 83d
QIAstat-Dx Gastrointestinal Panel 2; QIAstat-Dx GI Panel 2 Mini B&V; QIAstat-Dx GI Panel 2 Mini B
K252329 · PCH Gastrointestinal Pathogen... · Microbiology
Oct 2025 89d
QIAstat-Dx Respiratory Panel Plus; QIAstat-Dx Respiratory Panel Mini
K250080 · QOF Multi-target Respiratory... · Microbiology
Aug 2025 226d
QIAstat-Dx GI Panel 2 Mini B
K250324 · PCH Gastrointestinal Pathogen... · Microbiology
Feb 2025 23d
QIAstat-Dx GI Panel 2 Mini B&V
K243813 · PCH Gastrointestinal Pathogen... · Microbiology
Jan 2025 28d
QIAstat-Dx Meningitis/Encephalitis (ME) Panel
K242256 · PLO Meningitis/encephalitis... · Microbiology
Oct 2024 90d
QIAstat-Dx Respiratory Panel Mini
K242353 · QOF Multi-target Respiratory... · Microbiology
Oct 2024 78d
QIAstat-Dx Gastrointestinal Panel 2
K220062 · PCH Gastrointestinal Pathogen... · Microbiology
May 2024 872d
QIAstat-Dx? Respiratory Panel Plus
K233100 · QOF Multi-target Respiratory... · Microbiology
May 2024 227d
QIAstat-Dx Respiratory Panel
K183597 · OCC Respiratory Virus Panel... · Microbiology
May 2019 148d
ARTUS C. DIFFICILE QS-RGQ MDX KIT
K133936 · OZN C. Difficile Toxin Gene... · Microbiology
Apr 2014 102d
ROTOR-GENE Q MDX
K113319 · OOI Real Time Nucleic Acid... · Microbiology
Feb 2012 88d
ARTUS INFL A/B RG RT-PCR KIT
K113323 · OCC Respiratory Virus Panel... · Microbiology
Feb 2012 88d
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