BEUDAMED
    FDA Registration Active 🇺🇸 United States

    ABBOTT POINT OF CARE INC.

    Reg #: 2245578 · FEI: 2245578 · Expires 2026
    View on FDA
    Products
    22
    Proprietary Names
    66
    Establishment Types
    3
    Classifications
    22

    Registration Details

    Registration Name
    ABBOTT POINT OF CARE INC.
    Registration Number
    2245578
    FEI Number
    2245578
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    400 College Road East
    City
    Princeton
    State
    NJ
    ZIP
    08540
    Country
    US

    Regulatory Submissions

    510(k) Number
    K080973

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

    Proprietary Names

    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 CG8+ cartridge, i-STAT 1 analyzer i-STAT 1 Analyzer (Models 300 & 300-G) i-STAT CHEM8+ cartridge with the i-STAT 1 System i-STAT TBI Plasma Cartridge with the i-STAT Alinity System 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 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 PTplus Cartridge i-STAT PTplus Cartridge with i-STAT 1 System i-STAT PTplus Control Level 1 i-STAT PTplus Control Level 2 iSTAT b-hCG Calibration Verification Controls Level 1, 2 & 3 iSTAT b-hCG Controls Level 1, 2 & 3 i-STAT Alinity Instrument (Model AN-500) i-STAT Sodium Test i-STAT Controls i-STAT CHEM8+ Calibration Verificat i-STAT CHEM8+ Controls i-STAT Calibration Verification Set i-STAT TriControls Control i-STAT CG4+ Cartridge with the i-STAT 1 System i-STAT 1 analyzer i-STAT hs-TnI cartridge i-STAT ACT Controls i-STAT PT Controls I-STAT Dispensing Tip i-STAT G cartridge 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 CG4+ cartridge, i-STAT 1 analyzer i-STAT G3+ cartridge

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device Develop Specifications But Do Not Manufacture At This Facility