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Qiagen, Inc.

US

Last updated September 17, 2026

Part of QIAGEN GmbH

Information

Country
US
Address
19300 Germantown Rd, Germantown, MD, 20874
Website
—
LinkedIn
—
Facebook
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Email
—
Phone
—
PRRC Contact
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EUDAMED SRN
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FDA FEI Number
3003572099
DUNS Number
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Catalogue (71)

Page 1 of 2
DeviceModel / ReferenceRegistriesClassStatus
QIAsymphony DSP DNA Midi Kit 1
FDA UDI
Class IActive
artus® C. difficile QS-RGQ MDx Kit 1
FDA UDI
Class IIUnknown
therascreen® KRAS RGQ PCR Kit 1
FDA UDI
Class IIIActive
EZ1 DSP DNA Blood Kit 3
FDA UDI
Class IActive
BK Virus Probe ASR 1
FDA UDI
Class IActive
QIAensemble Decapper System 1
FDA UDI
Class IUnknown
ipsogen® JAK2 RGQ PCR Kit V1
FDA UDI
Class IIActive
artus® CMV RGQ MDx Kit 1
FDA UDI
Class IIActive
QIAamp DSP Viral RNA Mini Kit 1
FDA UDI
Class IActive
EZ1® DSP Virus Kit 5
EUDAMEDFDA UDI
Class IActive
QIAstat-Dx® GI Panel 2 Mini B&V V1
FDA UDI
Class IIActive
QIAsymphony DSP AXpH DNA Kit 1
FDA UDI
Class IUnknown
artus® CMV QS-RGQ MDx Kit 1
FDA UDI
Class IIActive
QIAamp DSP DNA Mini Kit 2
FDA UDI
Class IActive
QIAstat-Dx® GI Panel 2 Mini B V1
FDA UDI
Class IIActive
Rotor-Gene® Q MDx 1
FDA UDI
Class IIActive
HSV Positive Control 1
FDA UDI
Class IActive
QIAsymphony® DSP Virus/Pathogen Mini Kit 2
EUDAMEDFDA UDI
Class IActive
BK Virus Positive Control 1
FDA UDI
Class IActive
QIAstat-Dx® Respiratory Panel V1
FDA UDI
Class IIUnknown
QIAstat-Dx® Respiratory Panel Plus V1
FDA UDI
Class IIUnknown
QIAstat-Dx® Respiratory Panel Mini 1
FDA UDI
Class IIActive
therascreen® EGFR RGQ PCR Kit 1
FDA UDI
Class IIIActive
VZV Positive Control 1
FDA UDI
Class IActive
CMV Probe ASR V1
FDA UDI
Class IUnknown
EZ1 DSP Virus Kit 4
FDA UDI
Class IActive
QIAstat-Dx® Gastrointestinal Panel 2 V2
FDA UDI
Class IIActive
QIAsymphony DSP Virus/Pathogen Midi Kit 1
FDA UDI
Class IActive
QIAamp DSP Virus Kit 1
FDA UDI
Class IActive
HSV Primer ASR 1
FDA UDI
Class IActive
VZV Probe ASR 1
FDA UDI
Class IActive
QIAsymphony® DSP Virus/Pathogen Midi Kit 2
EUDAMEDFDA UDI
Class IActive
RNeasy® DSP FFPE Kit 2
FDA UDI
Class IActive
BK Virus Primer ASR 1
FDA UDI
Class IActive
QIAsymphony DSP Virus/Pathogen Mini Kit 1
FDA UDI
Class IActive
QIAstat-Dx® Rise 1
EUDAMEDFDA UDI
Class IIActive
VZV Primer ASR 1
FDA UDI
Class IActive
EZ1 Advanced 1
FDA UDI
Class IActive
Buffer AVL (w/o carrier RNA, 155 ml) 1
FDA UDI
Class IActive
therascreen® FGFR RGQ RT-PCR Kit 2
FDA UDI
Class IIIActive
QIAamp DSP Virus Spin Kit 1
FDA UDI
Class IActive
therascreen® FGFR RGQ RT-PCR Kit V1
FDA UDI
Class IIIActive
QIAGEN Proteinase K 1
FDA UDI
Class IActive
QIAamp DSP DNA FFPE Tissue Kit 1
FDA UDI
Class IActive
therascreen® PDGFRA RGQ PCR Kit 1
FDA UDI
Class IIIActive
CMV Primer ASR V1
FDA UDI
Class IUnknown
HSV-2 Probe ASR 1
FDA UDI
Class IActive
therascreen® BRAF RGQ PCR Kit 1
FDA UDI
Class IIIActive
therascreen® PIK3CA RGQ PCR Kit V1
FDA UDI
Class IIIActive
QIAamp DSP DNA Blood Mini Kit 2
FDA UDI
Class IActive

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