BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    QIAGEN, GMBH

    Reg #: 3004013603 · FEI: 3004013603 · Expires 2026
    View on FDA
    Products
    16
    Proprietary Names
    63
    Establishment Types
    3
    Classifications
    16

    Registration Details

    Registration Name
    QIAGEN, GMBH
    Registration Number
    3004013603
    FEI Number
    3004013603
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    QIAGEN STRASSE 1
    City
    HILDEN North Rhine-Westphalia
    Country
    DE

    Regulatory Submissions

    510(k) Number
    K220062
    PMA Number
    P210002

    Owner / Operator

    Firm Name
    QIAGEN, GmbH
    Operator Number
    9065957
    Address
    QIAGEN STRASSE 1, --
    City
    HILDEN
    State
    DE-NOTA
    Postal Code
    40724
    Country
    DE

    US Agent

    Business Name
    QIAGEN
    Contact Name
    Hina Patel
    Address
    19300 Germantown Rd.
    City
    Germantown
    State
    MD
    ZIP
    20874
    Country
    US
    Email
    [email protected]
    Phone
    240 4773805

    Products

    Device Name Product Code
    Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System PCH
    Jak2 Gene Mutation Detection Test PSU
    Somatic Gene Mutation Detection System OWD
    System, Blood Collection, Rna Stabilization, Rna Purification, Rt-Pcr Molecular Diagnostic Test NTW
    Real Time Nucleic Acid Amplification System OOI
    Clinical Sample Concentrator JJH
    Colorimeter, Photometer, Spectrophotometer For Clinical Use JJQ
    Cytomegalovirus (Cmv) Dna Quantitative Assay PAB
    Multi-Analyte Controls Unassayed OHQ
    C. Difficile Toxin Gene Amplification Assay OZN
    Droplet Digital Pcr System PHG
    Meningitis/Encephalitis Pathogen Multiplex Nucleic Acid Detection System PLO
    General Purpose Reagent PPM
    Reagents, 2019-Novel Coronavirus Nucleic Acid QJR
    Reagents, Specific, Analyte MVU
    Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents QOF

    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 EBV Primer ASR EBV Probe ASR HSV-1 Probe ASR HSV Primer ASR VZV Primer ASR BK Virus Probe ASR BK Virus Primer ASR VZV Probe ASR HSV-2 Probe ASR QIAstat-Dx Respiratory Panel Plus QIAstat-Dx Respiratory Panel Mini

    Establishment Types

    Manufacture Medical Device Manufacture Medical Device for Another Party (Contract Manufacturer) Develop Specifications But Do Not Manufacture At This Facility