BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Abbott Diagnostics Scarborough, Inc.

    Reg #: 1221359 · FEI: 1221359 · Expires 2026
    View on FDA
    Products
    24
    Proprietary Names
    65
    Establishment Types
    5
    Classifications
    24

    Registration Details

    Registration Name
    Abbott Diagnostics Scarborough, Inc.
    Registration Number
    1221359
    FEI Number
    1221359
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    10 Southgate Rd
    City
    Scarborough
    State
    ME
    ZIP
    04074
    Country
    US

    Regulatory Submissions

    510(k) Number
    K133851
    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
    System, Test, Genotypic Detection, Resistant Markers, Staphylococcus Colonies MYI
    Multi-Analyte Respiratory Virus Antigen Detection Test SCA
    Simple Point-Of-Care Device To Detect Sar-Cov-2 Nucleic Acid Targets From Clinical Specimens In Near-Patient Settings QWR
    Real Time Nucleic Acid Amplification System OOI
    Groups A, C And G Beta-Hemolytic Streptococcus Nucleic Acid Amplification System PGX
    Assay For Detection Of Proteases In Chronic Wounds QFA
    Glucose-6-Phosphate Dehydrogenase (Erythrocytic), Screening JBF
    Point Of Care Hiv Serology Diagnostic And/Or Supplemental Test QSU
    Coronavirus Antigen Detection Test System. QKP
    Antisera, All Groups, Streptococcus Spp. GTZ
    Legionella, Spp., Elisa MJH
    System, Test, Tumor Marker, Monitoring, Bladder MMW
    Reagents, 2019-Novel Coronavirus Nucleic Acid QJR
    Human Metapneumovirus (Hmpv) Rna Assay System OEM
    Respiratory Virus Panel Nucleic Acid Assay System OCC
    Antigen, Cf (Including Cf Controls), Respiratory Syncytial Virus GQG
    Plasmodium Spp. Detection Reagents OAX
    Cell Enzymes (Erythrocytic And Leukocytic) JBE
    Influenza A And Influenza B Multiplex Nucleic Acid Assay OZE
    System, Test, Tumor Marker, For Detection Of Bladder Cancer NAH
    Devices Detecting Influenza A, B, And C Virus Antigens PSZ
    Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use LXG
    Device, General Purpose, Microbiology, Diagnostic LIB
    Kit, Direct Antigen, Positive Control MJZ

    Proprietary Names

    Clearview PBP2a SA Culture Colony Test BinaxNOW COVID-19/Flu A&B Combo Self Test BinaxNOW COVID-19/Flu A&B ID NOW COVID-19 2 ID NOW COVID-19 2 Control Swab Kit ID NOW™ Molecular System Alere i Strep A 2 ID NOW™ Instrument Alere i Instrument ID NOW™ Strep A 2 WOUNDCHEK Bacterial Status Control Kit WOUNDCHEK Bacterial Status BinaxNow G6PD 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 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 Strep A Card Alere BinaxNOW Strep A Card BinaxNow Strep A Test Alere BinaxNOW Legionlla Urinary Antigen Card BinaxNOW Legionella Urinary Antigen Card BinaxNOW Legionella Urinary Antigen Test BinaxNOW Streptococcus pneumoniae Antigen Card BinaxNOW Streptococcus pneumoniae Test Alere BinaxNOW Streptococcus pneumoniae Antigen Card Alere NMP22 BladderChek Control Kit Matritech NMP22 BladderChek Control Kit NMP22 BladderChek Control Kit Abbott Bulk Universal Collection Kit (List 09N92-010) Legionella Urinary Antigen Enzyme Immunoassay Kit Alere i RSV ID NOW™ RSV BinaxNOW RSV Test Alere BinaxNOW RSV Card BinaxNOW RSV Card BinaxNow Malaria Test BinaxNOW Malaria Positive Control NMP22 Urine Collection Kit Matritech NMP22 ELISA Test Kit Matritech NMP22 Bladdercheck Test NMP22 BladderChek Test NMP22 Test Alere NMP22 Test Kit Alere NMP22 BladderChek Test BinaxNOW Influenza A & B Card BinaxNOW Influenza A & B Control Swab Kit Swab Transport Tube Accessory Pack Determine TB LAM Ag Alere Filariasis Test Strip Alere Determine TB LAM Ag BinaxNOW Filariasis Bioline Filariasis Test Strip Alere Reader Alere BinaxNOW Influenza A & B Card 2 BinaxNOW Influenza A & B Card 2 DIGIVAL ID NOW™ Influenza A & B 2 Alere i Influenza A & B 2

    Establishment Types

    Manufacture Medical Device Repack or Relabel Medical Device Develop Specifications But Do Not Manufacture At This Facility Complaint File Establishment per 21 CFR 820.198 Manufacture Device in the United States for Export Only