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Qiagen, GmbH

FDA Regulatory Profile

Summary

Total Recalls
6
510(k) Clearances
16
Inspections
4
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-2665-2023Class IItherascreen ¿KRAS RGQ PCR Kit (24)-IVD qualitative PCR assay used on the Rotor-Gene Q MDx instrumentAugust 22, 2023
Z-2245-2023Class IIQIAstat-Dx Respiratory SARS-CoV-2 Panel -US IVD qualitative test intended for analyzing nasopharyngeMay 19, 2023
Z-2246-2023Class IIQIAstat-Dx Respiratory SARS-CoV-2 Panel (V1 and V2, CE IVD, not US IVD, not sold in the US.) QualMay 19, 2023
Z-2215-2023Class IIQIAstat-Dx¿ Respiratory SARS-CoV-2 Panel -IVD intended for the detection and differentiation of nuclMay 9, 2023
Z-2596-2018Class IIEZ1 DSP Virus Kit (48), IVD, REF 62724 intended for in vitro diagnostic use.May 28, 2018
Z-0274-2018Class IIQIAamp DSP Virus Kit Cat. No. 60704July 22, 2017

Recent 510(k) Clearances

K-NumberDeviceDate
K254032QIAstat-Dx Gastrointestinal Panel 2; QIAstat-Dx GI Panel 2 Mini B&V; QIAstat-Dx GI Panel 2 Mini BMarch 9, 2026
K252329QIAstat-Dx Gastrointestinal Panel 2; QIAstat-Dx GI Panel 2 Mini B&V; QIAstat-Dx GI Panel 2 Mini BOctober 22, 2025
K250080QIAstat-Dx Respiratory Panel Plus; QIAstat-Dx Respiratory Panel MiniAugust 27, 2025
K250324QIAstat-Dx GI Panel 2 Mini BFebruary 28, 2025
K243813QIAstat-Dx GI Panel 2 Mini B&VJanuary 8, 2025
K242256QIAstat-Dx Meningitis/Encephalitis (ME) PanelOctober 29, 2024
K242353QIAstat-Dx Respiratory Panel MiniOctober 25, 2024
K220062QIAstat-Dx Gastrointestinal Panel 2May 31, 2024
K233100QIAstat-Dx® Respiratory Panel PlusMay 10, 2024
K183597QIAstat-Dx Respiratory PanelMay 18, 2019
K172287ipsogen JAK2 RGQ PCR KitJanuary 12, 2018
DEN160028ipsogen JAK2 RGQ PCR KitMarch 27, 2017
K142738artus HSV-1/2 QS-RGQ MDx KitDecember 19, 2014
K133936ARTUS C. DIFFICILE QS-RGQ MDX KITApril 4, 2014
K113319ROTOR-GENE Q MDXFebruary 6, 2012
K113323ARTUS INFL A/B RG RT-PCR KITFebruary 6, 2012