BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    Alinity c Microalbumin Controls - LN 08P0410

    Reg #: 3002809144 · FEI: 3002809144 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    12
    Establishment Types
    1
    Classifications
    3

    Registration Details

    Registration Name
    ABBOTT GmbH
    Registration Number
    3002809144
    FEI Number
    3002809144
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Max-Planck-Ring 2
    City
    Wiesbaden Hesse
    Country
    DE

    Regulatory Submissions

    510(k) Number
    K030320

    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

    US Agent

    Business Name
    ABBOTT LABORATORIES
    Contact Name
    Sara Qadri
    Address
    675 N Field Dr, Dept C2D8 Bldg CP01 Floor-3
    City
    Lake Forest
    State
    IL
    ZIP
    60045
    Country
    US
    Email
    [email protected]
    Phone
    224 6680142

    Products

    Device Name Product Code
    Calibrator, Primary JIS
    Single (Specified) Analyte Controls (Assayed And Unassayed) JJX
    Turbidimetric Method, Protein Or Albumin (Urinary, Non-Quant.) JIQ

    Proprietary Names

    Alinity c Microalbumin Controls - LN 08P0410 Alinity c Microalbumin Calibrators - LN 08P0401 Alinity c Microalbumin Reagent Kit - LN 08P0420 Microalbumin Calibrators - LN 02K9802 and 02K9803 Microalbumin - LN 02K9820 and 02K9821 Microalbumin Controls - LN 02K9810 and 02K9811 Microalbumin (Alinity c, LN 08P0424) Microalbumin Calibrators (Alinity c, LN 08P0404) Microalbumin (ARCHITECT; LN 02K9824) Microalbumin Controls (Alinity c, LN 08P0414) Microalbumin Calibrators (ARCHITECT; LN 02K9804) Microalbumin Controls (ARCHITECT; LN 02K9814)

    Establishment Types

    Export Device to the United States But Perform No Other Operation on Device