BEUDAMED
    FDA Registration Active 🇸🇪 Sweden

    Quality Club EliA Autoimmunity

    Reg #: 9610566 · FEI: 3002807876 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    6
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    PHADIA AB
    Registration Number
    9610566
    FEI Number
    3002807876
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    RAPSGATAN 7P
    City
    UPPSALA
    Country
    SE

    Owner / Operator

    Firm Name
    PHADIA AB
    Operator Number
    9004441
    Address
    Rapsgatan 7P, P.O. Box 6460
    City
    UPPSALA
    State
    SE-C
    Postal Code
    75137
    Country
    SE

    US Agent

    Business Name
    Phadia US Inc.
    Contact Name
    Carla Krause
    Address
    4169 Commercial Avenue
    City
    Portage
    State
    MI
    ZIP
    49002
    Country
    US
    Email
    [email protected]
    Phone
    616 2864138

    Products

    Device Name Product Code
    Multi-Analyte Controls Unassayed OHQ

    Proprietary Names

    Quality Club EliA Autoimmunity Quality Club Total IgE Quality Club Specific IgE AESQC® ANA HEp-2 Nucleolar; AESQC® ANA HEp-2 Panel 1; AESQC® ANA HEp-2 Speckled; AESQC® IFA Negative Control AESQC® Pool 1; AESQC® Pool 2; AESQC® Pool 3; AESQC® Pool 4; AESQC® Pool 5; AESQC® Pool Mix AESQC® ANA HEp-2 Centromere; AESQC® ANA HEp-2 Cytoplasmic; AESQC® ANA HEp-2 Homogeneous

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device