BEUDAMED
    FDA Registration Active 🇺🇸 United States

    ARCHITECT HE4 Reagent Kit - LN 02P5427

    Reg #: 3005333358 · FEI: 3005333358 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    4
    Establishment Types
    1
    Classifications
    3

    Registration Details

    Registration Name
    ABBOTT LABORATORIES
    Registration Number
    3005333358
    FEI Number
    3005333358
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Conway Park, 675 North Field Drive
    City
    Lake Forest
    State
    IL
    ZIP
    60045
    Country
    US

    Regulatory Submissions

    510(k) Number
    K093957

    Owner / Operator

    Firm Name
    ABBOTT LABORATORIES
    Operator Number
    1415939
    Address
    100 ABBOTT PARK RD., D-03Q3, AP52-1
    City
    Abbott Park
    State
    IL
    Postal Code
    60064
    Country
    US

    Products

    Device Name Product Code
    Single (Specified) Analyte Controls (Assayed And Unassayed) JJX
    Calibrator, Secondary JIT
    Test, Epithelial Ovarian Tumor Associated Antigen (He4) OIU

    Proprietary Names

    ARCHITECT HE4 Reagent Kit - LN 02P5427 ARCHITECT HE4 Calibrators - LN 02P5401 ARCHITECT HE4 Controls - LN 02P5410 Alinity i HE4 Reagent Kit - LN 08P5021

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198