BEUDAMED
    FDA Registration Active 🇺🇸 United States

    ImmunoCAP Allergen e220, Allergen component rFel d 2 Cat serum albumin

    Reg #: 3004973408 · FEI: 3004973408 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    12
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    PHADIA US INC.
    Registration Number
    3004973408
    FEI Number
    3004973408
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    4169 COMMERCIAL AVE.
    City
    Portage
    State
    MI
    ZIP
    49002
    Country
    US

    Regulatory Submissions

    510(k) Number
    K101251

    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

    Products

    Device Name Product Code
    System, Test, Radioallergosorbent (Rast) Immunological DHB

    Proprietary Names

    ImmunoCAP Allergen e220, Allergen component rFel d 2 Cat serum albumin ImmunoCAP Allergen g216, Allergen component nCyn d 1 Bermuda grass ImmunoCAP Allergen f424, Allergen component rAra h 3 Peanut ImmunoCAP Allergen e94, Allergen component rFel d 1 Cat ImmunoCAP Allergen m229, Allergen component rAlt a 1, Alternaria alternata ImmunoCAP Allergen f352, Allergen component rAra h 8 PR-10, Peanut ImmunoCAP Allergen d203, Allergen component rDer p 2, House dust mite ImmunoCAP Allergen d205, Allergen component rDer p 10 Tropomyosin, House dust mite ImmunoCAP Allergen w230, Allergen component nAmb a 1 Ragweed ImmunoCAP Allergen f423, Allergen component rAra h 2 Peanut ImmunoCAP Allergen f422, Allergen component rAra h 1 Peanut ImmunoCAP Allergen f427, Allergen component rAra h 9 LTP, Peanut

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198