BEUDAMED
    FDA Registration Active 🇨🇦 Canada

    ABBOTT POINT OF CARE CANADA LIMITED

    Reg #: 3005643513 · FEI: 3005643513 · Expires 2026
    View on FDA
    Products
    24
    Proprietary Names
    84
    Establishment Types
    2
    Classifications
    24

    Registration Details

    Registration Name
    ABBOTT POINT OF CARE CANADA LIMITED
    Registration Number
    3005643513
    FEI Number
    3005643513
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    185 CORKSTOWN ROAD
    City
    Ottawa Ontario
    Country
    CA

    Regulatory Submissions

    510(k) Number
    K121237

    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 Point of Care
    Contact Name
    Jose Colon
    Address
    400 College Road East
    City
    Princeton
    State
    NJ
    ZIP
    08540
    Country
    US
    Email
    [email protected]
    Phone
    609 4549356

    Products

    Device Name Product Code
    Single (Specified) Analyte Controls (Assayed And Unassayed) JJX
    Electrolyte Controls (Assayed And Unassayed) JJR
    Control, Hematocrit GLK
    Electrode, Ion Specific, Potassium CEM
    Electrode, Ion Specific, Sodium JGS
    Electrode, Ion Specific, Urea Nitrogen CDS
    Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph CHL
    Device, Hematocrit Measuring JPI
    Biosensor, Immunoassay, Cpk Or Isoenzymes MYT
    Electrode, Ion Based, Enzymatic, Creatinine CGL
    Test, Time, Prothrombin GJS
    Electrode, Ion Specific, Calcium JFP
    Glucose Oxidase, Glucose CGA
    Test, Natriuretic Peptide NBC
    Acid, Lactic, Enzymatic Method KHP
    Ph Rate Measurement, Carbon-Dioxide JFL
    Activated Whole Blood Clotting Time JBP
    Immunoassay Method, Troponin Subunit MMI
    Electrode, Ion-Specific, Chloride CGZ
    Analyzer, Chemistry (Photometric, Discrete), For Clinical Use JJE
    Multi-Analyte Controls, All Kinds (Assayed) JJY
    System, Test, Human Chorionic Gonadotropin DHA
    Brain Trauma Assessment Test QAT
    Plasma, Coagulation Control GGN

    Proprietary Names

    iSTAT b-hCG Calibration Verification Controls Level 1, 2 & 3 iSTAT b-hCG Controls Level 1, 2 & 3 i-STAT TriControls Control i-STAT CG8+ cartridge, i-STAT 1 analyzer i-STAT E3+ Cartridge i-STAT cTnI Cartridge i-STAT CG4+ Cartridge i-STAT EG7+ Cartridge i-STAT Celite ACT Cartridge i-STAT G3+ Cartridge i-STAT CHEM8+ Cartridge i-STAT CREA Cartridge i-STAT 6+ Cartridge i-STAT CG8+ Cartridge i-STAT CK-MB Cartridge i-STAT Kaolin ACT Cartridge i-STAT EC4+ Cartridge i-STAT EG6+ Cartridge i-STAT G Cartridge i-STAT PT/INR Cartridge i-STAT BNP Cartridge i-STAT EC8+ Cartridge i-STAT Wireless Analyzer (Model 300W) I-STAT CREATININE TEST Alinity c Proteins Control Kit (LN 08P6712) Alinity i STAT Myoglobin Controls (LN 04V3710) Alinity i Anti-CCP Controls (LN 09P2710) Alinity c CRP Vario HS Control Kit (LN 07P5612) i-STAT TBI Calibration Verification Alinity i STAT CK-MB Controls (LN 04V3810) i-STAT TBI Controls i-STAT hs-TnI Control Level 2 i-STAT hs-TnI Control Level 3 i-STAT hs-TnI Control Level 1 i-STAT hs-TnI Calibration Verification Levels 1-3 i-STAT® Total ?-hCG Test i-STAT CHEM8+ cartridge with the i-STAT 1 System i-STAT BNP Controls i-STAT BNP Calibration Verification i-STAT CK-MB controls i-STAT CK-MB Calibration Verification Control Set i-STAT cTnI Calibration Verification 1-3 i-STAT cTnI Controls i-STAT CG4+ Cartridge with the i-STAT 1 System i-STAT PTplus Cartridge i-STAT PTplus Cartridge with i-STAT 1 System i-STAT PTplus Control Level 1 i-STAT PTplus Control Level 2 i-STAT TBI cartridge i-STAT TBI Calibration Verification Levels 1-3 i-STAT TBI Control Level 2 i-STAT TBI Control Level 1 i-STAT Alinity Instrument (Model AN-500) i-STAT Sodium Test i-STAT 1 analyzer i-STAT hs-TnI cartridge I-STAT PROTHROMBIN TIME TEST I-STAT CK-MB TEST i-STAT Creatine Kinase MB Test i-STAT Troponin I Test i-STAT ACT Controls i-STAT PT Controls i-STAT PH Test i-STAT PCO2 Test i-STAT PO2 Test i-STAT Potassium Test i-STAT G3+ cartridge i-STAT Lactate Test i-STAT Controls i-STAT CHEM8+ Calibration Verificat i-STAT CHEM8+ Controls i-STAT Calibration Verification Set I-STAT TC02 TEST ION SPECIFIC I-STAT TCO2 TEST i-STAT TBI Plasma Cartridge with the i-STAT Alinity System i-STAT ACT Test I-STAT BNP TEST i-STAT G cartridge i-STAT CG4+ cartridge, i-STAT 1 analyzer i-STAT Chloride Test i-STAT Hematocrit Test i-STAT Glucose Test i-STAT BUN Test

    Establishment Types

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