BEUDAMED
    FDA Registration Active 🇺🇸 United States

    AAV5 DetectCDx

    Reg #: 3004741920 · FEI: 3004741920 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    ARUP LABORATORIES
    Registration Number
    3004741920
    FEI Number
    3004741920
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    500 Chipeta Way, Mail Code 241
    City
    Salt Lake City
    State
    UT
    ZIP
    84108
    Country
    US

    Regulatory Submissions

    PMA Number
    P190033

    Owner / Operator

    Firm Name
    ARUP Laboratories
    Operator Number
    10050613
    Address
    500 Chipeta Way
    City
    Salt Lake City
    State
    UT
    Postal Code
    84108
    Country
    US

    Products

    Device Name Product Code
    Assays To Detect Pre-Existing Antibodies To Adeno-Associated Virus (Aav) Viral Vectors QWQ

    Proprietary Names

    AAV5 DetectCDx

    Establishment Types

    Manufacture Medical Device