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QIAGEN GmbH

Germany·DE-MF-000004949

Last updated May 24, 2026

Information

Country: Germany
Address: 1, QIAGEN Strasse, Hilden, Germany
Website: www.qiagen.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: +492103290
PRRC Contact: Marcus Rembges
EUDAMED SRN: DE-MF-000004949
FDA FEI Number: —
DUNS Number: 317103745

Catalogue (55)

Page 1 of 2

Device	Model / Reference	Registries	Class	Status
Rotor-Gene Q MDx 5Plex	9002020	EUDAMED	Class A	Active
careBrush	619024	EUDAMED	Class I	Active
ipsogen RT Kit	679823	EUDAMED	Class A	Active
Rotor-Gene Q MDx 6plex	9002040	EUDAMED	Class A	Active
QFT-Plus Reference Lab Pack	622822	EUDAMED	Class C	Active
QIAstat-Dx BCID GPF Plus AMR Panel	691812	EUDAMED	Class C	Active
QFT-Plus Dispenser Pack	622423	EUDAMED	Class C	Active
QFT-Plus Single Patient Pack	622222	EUDAMED	Class C	Active
QFT-Plus HA Dispenser Pack	623423	EUDAMED	Class C	Active
QFT-Plus tubes	622526	EUDAMED	Class C	Active
RNeasy DSP MinElute Cleanup Kit	78244	EUDAMED	Class A	Active
EZ2 Connect MDx	9003230	EUDAMED	Class A	Active
QFT-Plus 2 Plate Kit ELISA	622120	EUDAMED	Class C	Active
Rotor-Gene Q MDx 5Plex HRM	9002030	EUDAMED	Class A	Active
QFT-Plus HA Single Patient Pack	623222	EUDAMED	Class C	Active
EZ1 DSP DNA Blood Kit	62124	EUDAMEDFDA UDI	Class A	Active
QIAsymphony SP	9001297	EUDAMEDFDA UDI	Class A	Active
Buffer EL	79218	EUDAMED	Class A	Active
QIAstat-Dx Meningitis/Encephalitis (ME) Panel	K242256	FDA 510(k)	Class II	Active
QIAstat-Dx Gastrointestinal Panel 2	K220062	FDA 510(k)	Class II	Active
QIAstat-Dx Respiratory Panel	K183597	FDA 510(k)	Class II	Active
QIAstat-Dx Gastrointestinal Panel 2; QIAstat-Dx GI Panel 2 Mini B&V; QIAstat-Dx GI Panel 2 Mini B	K254032	FDA 510(k)	Class II	Active
Artus Infl A/B Rg Rt-Pcr Kit	K113323	FDA 510(k)	Class II	Active
QIAstat-Dx® Respiratory Panel Plus	K233100	FDA 510(k)	Class II	Active
Artus C. Difficile Qs-Rgq Mdx Kit	K133936	FDA 510(k)	Class II	Active
QIAstat-Dx Respiratory Panel Mini	K242353	FDA 510(k)	Class II	Active
QIAstat-Dx Respiratory Panel Plus; QIAstat-Dx Respiratory Panel Mini	K250080	FDA 510(k)	Class II	Active
QIAstat-Dx GI Panel 2 Mini B&V	K243813	FDA 510(k)	Class II	Active
QIAstat-Dx GI Panel 2 Mini B	K250324	FDA 510(k)	Class II	Active
Rotor-Gene Q Mdx	K113319	FDA 510(k)	Class II	Active
QIAstat-Dx Gastrointestinal Panel 2; QIAstat-Dx GI Panel 2 Mini B&V; QIAstat-Dx GI Panel 2 Mini B	K252329	FDA 510(k)	Class II	Active
QIAsymphony DSP Circulating DNA Kit (96)	937555	EUDAMEDFDA UDI	Class A	Active
QIAsymphony DSP Circulating DNA Kit (192)	937556	EUDAMEDFDA UDI	Class A	Active
QIAamp DSP Virus Kit	60704	EUDAMEDFDA UDI	Class A	Active
QIAstat-Dx Operational Module	9002813	EUDAMEDFDA UDI	Class A	Active
careHPV Test Shaker	9001774	EUDAMED	Class A	Active
QIAsymphony DSP Circulating DNA Maxi Kit (192)	937566	EUDAMEDFDA UDI	Class A	Active
RNeasy DSP Midi Kit	78344	EUDAMED	Class A	Active
QIAamp DSP DNA FFPE Tissue Kit	60404	EUDAMEDFDA UDI	Class A	Active
QIAcuityDx Nanoplate 26k 24-well	260001	EUDAMEDFDA UDI	Class A	Active
QIAcube Connect MDx	9003070	EUDAMEDFDA UDI	Class A	Active
QIAcuityDx Four	911060	EUDAMEDFDA UDI	Class A	Active
QIAstat-Dx Analytical Module	9002814	EUDAMED	Class A	Active
QIAamp DSP DNA Blood Mini Kit	61104	EUDAMEDFDA UDI	Class A	Active
QIAamp DSP Virus Spin Kit	61704	EUDAMEDFDA UDI	Class A	Active
QIAsymphony AS	9001301	EUDAMEDFDA UDI	Class A	Active
careHPV Test Luminometer	9001773	EUDAMED	Class A	Active
QIAstat-Dx Operational Module PRO	9002826	EUDAMEDFDA UDI	Class A	Active
therascreen PDGFRA RGQ PCR Kit	P210002	FDA PMA	Class III	Active
therascreen® PIK3CA RGQ PCR Kit	P190001	FDA PMA	Class III	Active

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FDA Establishments (1)

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Qiagen, Inc. Germantown, MD · US FEI 3003572099