BEUDAMED
    FDA Registration Active 🇺🇸 United States

    ImmunoCAP Allergen g206, Allergen component rPhl p 2 Timothy

    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
    K111919

    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 g206, Allergen component rPhl p 2 Timothy ImmunoCAP Allergen f425, Allergen component rCor a 8, Hazel ImmunoCAP Allergen t215, Allergen component rBet v 1 PR-10, ImmunoCAP Allergen g212, Allergen component rPhl p 12 Profil ImmunoCAP Allergen t216, Allergen component rBet v 2 Profili ImmunoCAP Allergen g210, Allergen component rPhl p 7 Timothy ImmunoCAP Allergen t220, Allergen component rBet v 4 Birch ImmunoCAP Allergen g215, Allergen component rPhl p 5b Timoth ImmunoCAP Allergen g205, Allergen component rPhl p 1 Timothy ImmunoCAP Allergen t225, Allergen component rBet v6 Birch ImmunoCAP Allergen g209, Allergen component rPhl p 6 Timothy ImmunoCAP Allergen f428, Allergen component rCor a 1 PR-10 H

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198