BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Abbott Diagnostics Scarborough, Inc.

    Reg #: 3017662853 · FEI: 3017662853 · Expires 2026
    View on FDA
    Products
    12
    Proprietary Names
    37
    Establishment Types
    3
    Classifications
    12

    Registration Details

    Registration Name
    Abbott Diagnostics Scarborough, Inc.
    Registration Number
    3017662853
    FEI Number
    3017662853
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    5 Bradley Dr
    City
    Westbrook
    State
    ME
    ZIP
    04092
    Country
    US

    Regulatory Submissions

    510(k) Number
    K070522
    PMA Number
    BP120037

    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
    Legionella, Spp., Elisa MJH
    Plasmodium Spp. Detection Reagents OAX
    System, Test, Genotypic Detection, Resistant Markers, Staphylococcus Colonies MYI
    Antisera, All Groups, Streptococcus Spp. GTZ
    Devices Detecting Influenza A, B, And C Virus Antigens PSZ
    Glucose-6-Phosphate Dehydrogenase (Erythrocytic), Screening JBF
    Antigen, Cf (Including Cf Controls), Respiratory Syncytial Virus GQG
    Coronavirus Antigen Detection Test System. QKP
    Kit, Direct Antigen, Positive Control MJZ
    Point Of Care Hiv Serology Diagnostic And/Or Supplemental Test QSU
    Over-The-Counter Covid-19 Antigen Test QYT
    Multi-Analyte Respiratory Virus Antigen Detection Test SCA

    Proprietary Names

    Alere BinaxNOW Legionlla Urinary Antigen Card BinaxNOW Legionella Urinary Antigen Card BinaxNOW Legionella Urinary Antigen Test BinaxNow Malaria Test Clearview PBP2a SA Culture Colony Test BinaxNOW Streptococcus pneumoniae Antigen Card BinaxNOW Streptococcus pneumoniae Test Alere BinaxNOW Streptococcus pneumoniae Antigen Card Alere Reader Alere BinaxNOW Influenza A & B Card 2 BinaxNOW Influenza A & B Card 2 DIGIVAL BinaxNow G6PD Test BinaxNOW RSV Test Alere BinaxNOW RSV Card BinaxNOW RSV Card BinaxNOW COVID-19 Antigen Self-Test (EUA210264) BinaxNOW COVID-19 Ag Card Home Test (EUA203107) BinaxNOW COVID-19 Ag Card (EUA202537) Panbio™ COVID-19 Antigen Self-Test (Abbott Diagnostics Korea Inc.) BinaxNOW COVID-19 Positive Control Swab Kit BinaxNOW COVID-19 Reagent Accessory Pack BinaxNOW Malaria Positive Control BinaxNOW Strep A Card Alere BinaxNOW Strep A Card BinaxNow Strep A Test Alere Determine HIV-1/2 Ag/Ab Combo Determine HIV-1/2 Ag/Ab Combo Determine HIV-1/2 Ag/Ab Combo Controls Alere Determine HIV-1/2 Ag/Ab Combo Controls BinaxNOW™ COVID-19 Ag Card BinaxNOW™ COVID-19 Antigen Self Test BinaxNOW Influenza A & B Card BinaxNOW Influenza A & B Control Swab Kit BinaxNOW COVID-19/Flu A&B Combo Self Test BinaxNOW COVID-19/Flu A&B Legionella Urinary Antigen Enzyme Immunoassay Kit

    Establishment Types

    Manufacture Medical Device Manufacture Device in the United States for Export Only Repack or Relabel Medical Device