Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3004013603

FEI Number

3004013603

Entity Name

QIAGEN, GMBH

City/State/Country

HILDEN North Rhine-Westphalia, DE

Establishment Address

QIAGEN STRASSE 1, HILDEN North Rhine-Westphalia 40724, DE

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

QIAGEN, GmbH (Owner Number: 9065957)

Owner / Operator Contact Address

QIAGEN STRASSE 1, --, HILDEN, DE-NOTA 40724, DE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

P180043

All Registered Proprietary Names

QIAstat-Dx GI Panel 2 Mini B&V QIAstat-Dx Gastrointestinal Panel 2 QIAstat-Dx GI Panel 2 Mini B ipsogen® JAK2 RGQ PCR Kit therascreen PDGFRA RGQ PCR Kit therascreen® PIK3CA RGQ PCR Kit PAXGENE (TM) BLOOD RNA SYSTEM QIAsymphony RGQ MDx Rotor-Gene Q MDx QIAsymphony SP QIAamp DSP DNA Mini Kit QIAsymphony DSP Virus/Pathogen Kits QIAamp DSP Virus Spin Kit QIAamp DSP DNA FFPE Tissue Kit QIAsymphony DSP DNA Kits EZ1 DSP Virus Kit QIAamp DSP Viral RNA Mini Kit QIAamp DSP DNA Blood Mini Kit QIAamp DSP Virus Kit QIAcube QIAamp DSP Circulating NA Kit EZ1 Advanced XL EZ1 DSP DNA Blood Kit QIAsymphony DSP Circulating DNA Kit RNeasy DSP FFPE Kit QIAcube Connect MDx QIAsymphony DSP Circulating DNA Kit (96) EZ2® Connect MDx QIAsymphony DSP Circulating DNA Maxi Kit (192) aLF Lateral Flow Reader artus CMV RGQ MDx Kit EBV Positive Controls HSV Positive Control VZV Positive Control BK Virus Positive Control QIAcuityDx® Four QIAcuityDx® Nanoplate 26k 24-well QIAstat-Dx Meningitis-Encephalitis (ME) Panel therascreen® BRAF V600E RGQ PCR Kit QIAstat-Dx® Analyzer 1 QIAstat-Dx® Rise QIAstat-Dx® Analyzer 2 Deparaffinization solution Buffer ATL HotStarTaq® DNA Polymerase QIAGEN Proteinase K Buffer AVL Buffer ACL Buffer ASL QIAcuityDx® Universal MasterMix Kit QIAstat-Dx Respiratory SARS-CoV-2 Panel therascreen® FGFR RGQ RT-PCR Kit

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
PCH	Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System	Microbiology	Class 2	866.3990	2024-06-13
PSU	Jak2 Gene Mutation Detection Test	Medical Genetics	Class 2	866.6070	2017-05-18
OWD	Somatic Gene Mutation Detection System	Unknown	Class 3	N/A	2024-12-03
OWD	Somatic Gene Mutation Detection System	Unknown	Class 3	N/A	2019-05-29
NTW	System, Blood Collection, Rna Stabilization, Rna Purification, Rt-Pcr Molecular Diagnostic Test	Immunology	Class 2	866.4070	2005-11-04
OWD	Somatic Gene Mutation Detection System	Unknown	Class 3	N/A	2016-12-15
OOI	Real Time Nucleic Acid Amplification System	Clinical Chemistry	Class 2	862.2570	2012-06-08
JJH	Clinical Sample Concentrator	Clinical Chemistry	Class 1	862.2310	2008-06-19
JJQ	Colorimeter, Photometer, Spectrophotometer For Clinical Use	Clinical Chemistry	Class 1	862.2300	2019-04-12
PAB	Cytomegalovirus (Cmv) Dna Quantitative Assay	Microbiology	Class 2	866.3180	2014-08-19
OHQ	Multi-Analyte Controls Unassayed	Clinical Chemistry	Class 1	862.1660	2011-03-03
OOI	Real Time Nucleic Acid Amplification System	Clinical Chemistry	Class 2	862.2570	2014-06-11
OZN	C. Difficile Toxin Gene Amplification Assay	Microbiology	Class 2	866.3130	2014-06-11
PHG	Droplet Digital Pcr System	Clinical Chemistry	Class 2	862.2570	2024-09-25
PLO	Meningitis/Encephalitis Pathogen Multiplex Nucleic Acid Detection System	Microbiology	Class 2	866.3970	2025-01-21
OWD	Somatic Gene Mutation Detection System	Unknown	Class 3	N/A	2020-06-05
OOI	Real Time Nucleic Acid Amplification System	Clinical Chemistry	Class 2	862.2570	2019-05-22
PPM	General Purpose Reagent	Pathology	Class 1	864.4010	2005-07-05
QJR	Reagents, 2019-Novel Coronavirus Nucleic Acid	Unknown	Class N	N/A	2020-04-01
OWD	Somatic Gene Mutation Detection System	Unknown	Class 3	N/A	2019-04-18

Official Correspondent

No official correspondent registered.

US Agent Details

Hina Patel Business: QIAGEN Email: hina.patel@qiagen.com Phone: (240) 4773805

Related Public Records

Same Entity

QIAGEN, GmbH

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3014553740	STAT-Dx Life, S.L.	Barcelona, ES

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K760232	Instrumentation Laboratory CO	PRINTER, IL 460	1976-08-26

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0004-2022	Abbott Molecular, Inc.	N	Alinity m SARS-CoV-2 Amp Kit (Emergency Use Authorization, US Assay) and Alinity m SARS-CoV-2 Application Specification File. in vitro diagnostic
Z-0005-2022	Abbott Molecular, Inc.	N	Alinity m Resp-4-Plex AMP Kit (Emergency Use Authorization, US Assay) and Alinity m Resp-4-Plex Application Specification File. in vitro diagnostic
Z-0006-2022	Abbott Molecular, Inc.	N	Alinity m SARS-CoV-2 Amp Kit (Non-US Assay) and Alinity m SARS-CoV-2 Application Specification File. in vitro diagnostic
Z-0007-2022	Abbott Molecular, Inc.	N	Alinity m SARS-CoV-2 Amp Kit (Non-US Assay) and Alinity m SARS-CoV-2 Application Specification File. in vitro diagnostic
Z-0008-2022	Abbott Molecular, Inc.	N	Alinity m Resp-4-Plex AMP Kit (Non-US Assay) and Alinity m Resp-4-Plex Application Specification File. in vitro diagnostic

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004013603. Last updated year: 2026. Please use registration number 3004013603 when referencing this establishment in official correspondence.