BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Abbott Diagnostics Scarborough, Inc.

    Reg #: 3029059580 · FEI: 3029059580 · Expires 2026
    View on FDA
    Products
    3
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    3

    Registration Details

    Registration Name
    Abbott Diagnostics Scarborough, Inc.
    Registration Number
    3029059580
    FEI Number
    3029059580
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    65 Gannett Dr
    City
    Portland
    State
    ME
    ZIP
    04106
    Country
    US

    Regulatory Submissions

    510(k) Number
    K141520

    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
    Influenza A And Influenza B Multiplex Nucleic Acid Assay OZE
    Real Time Nucleic Acid Amplification System OOI
    Respiratory Virus Panel Nucleic Acid Assay System OCC

    Proprietary Names

    ID NOW™ Instrument

    Establishment Types

    Repack or Relabel Medical Device Manufacture Medical Device