BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Alere i Strep A 2

    Reg #: 1221359 · FEI: 1221359 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    5
    Establishment Types
    2
    Classifications
    2

    Registration Details

    Registration Name
    ABBOTT DIAGNOSTICS SCARBOROUGH, INC.
    Registration Number
    1221359
    FEI Number
    1221359
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    10 Southgate Rd
    City
    Scarborough
    State
    ME
    ZIP
    04074
    Country
    US

    Regulatory Submissions

    510(k) Number
    K173653

    Owner / Operator

    Firm Name
    Abbott
    Operator Number
    9006731
    Address
    100 Abbott Park Road, Dept. RX51/J55/MS 6134
    City
    Abbott Park
    State
    IL
    Postal Code
    60064
    Country
    US

    Products

    Device Name Product Code
    Real Time Nucleic Acid Amplification System OOI
    Groups A, C And G Beta-Hemolytic Streptococcus Nucleic Acid Amplification System PGX

    Proprietary Names

    Alere i Strep A 2 Alere i Instrument ID NOW™ Strep A 2 ID NOW™ Molecular System ID NOW™ Instrument

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device