BEUDAMED
    FDA Registration Active 🇺🇸 United States

    INSTRUMENTATION LABORATORY CO.

    Reg #: 2431530 · FEI: 2431530 · Expires 2026
    View on FDA
    Products
    44
    Proprietary Names
    146
    Establishment Types
    4
    Classifications
    44

    Registration Details

    Registration Name
    INSTRUMENTATION LABORATORY CO.
    Registration Number
    2431530
    FEI Number
    2431530
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    526 Route 303
    City
    ORANGEBURG
    State
    NY
    ZIP
    10962
    Country
    US

    Regulatory Submissions

    510(k) Number
    K981696

    Owner / Operator

    Firm Name
    Instrumentation Laboratory Co.
    Operator Number
    1217183
    Address
    180 Hartwell Road, --
    City
    Bedford
    State
    MA
    Postal Code
    01730
    Country
    US
    Correspondent
    Carol - Marble

    Products

    Device Name Product Code
    Test, Qualitative And Quantitative Factor Deficiency GGP
    Electrode, Ion Specific, Potassium CEM
    Electrode, Ion Specific, Calcium JFP
    Instrument, Hematocrit, Automated GKF
    Electrode, Ion-Specific, Chloride CGZ
    Enzymatic Method, Creatinine JFY
    Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph CHL
    Urease And Glutamic Dehydrogenase, Urea Nitrogen CDQ
    Glucose Oxidase, Glucose CGA
    Electrode, Ion Specific, Sodium JGS
    Acid, Lactic, Enzymatic Method KHP
    Enzymatic, Carbon-Dioxide KHS
    Plasma, Coagulation Factor Deficient GJT
    Plasma, Coagulation Control GGN
    Test, Fibrinogen GIS
    Test, Time, Prothrombin GJS
    Test, Thrombin Time GJA
    System, Fibrinogen Determination KQJ
    Activated Partial Thromboplastin GFO
    Test, Time, Partial Thromboplastin GGW
    Control, Plasma, Abnormal GGC
    Reagent, Russel Viper Venom GIR
    Drug Specific Control Materials LAS
    Fluorometric, Calcium JFO
    Control, Hematocrit GLK
    Assay, Heparin KFF
    Calibrators, Drug Specific DLJ
    Analyzer, Chemistry (Photometric, Discrete), For Clinical Use JJE
    Multi-Analyte Controls, All Kinds (Assayed) JJY
    Calibrator, Secondary JIT
    Assay, Oral Direct Thrombin Inhibitor QBG
    Oximeter To Measure Hemoglobin GLY
    System, Hemoglobin, Automated GKR
    Bilirubin (Total And Unbound) In The Neonate Test System MQM
    Assay, Carboxyhemoglobin GHS
    Quality Control Material, Genetics, Dna NZB
    Calibrator, Primary JIS
    Anti-Factor Xa Activity Test System, Apixaban QLU
    Antithrombin Iii Quantitation JBQ
    Diazo Colorimetry, Bilirubin CIG
    System, Multipurpose For In Vitro Coagulation Studies JPA
    Calibrator, Multi-Analyte Mixture JIX
    Plasma, Control, Normal GIZ
    Calculator/Data Processing Module, For Clinical Use JQP

    Proprietary Names

    HemosIL Plasmin Inhibitor HemosIL Plasminogen GEM Premier ChemSTAT GEM Premier ChemSTAT PAK HemosIL Factor XI Deficient Plasma HemosIL Abnormal Control 2 HemosIL Low Abnormal Control ASSAYED HemosIL RecombiPlasTin 2G (8 mL) HemosIL Q.F.A. Thrombin (Bovine) HemosIL Fibrinogen-C HemosIL Fibrinogen-C XL HemosIL Calcium Chloride 025 M HemosIL APTT-SP HemosIL Factor V Leiden HemosIL Factor V Reagent Plasma Coatest APC Resistance V S Coatest APC Resistance V ELECTRACHROME Factor VIII Coamatic Factor VIII HemosIL dRVVT Screen HemosIL dRVVT Confirm HemosIL Dabigatran Controls HemosIL Rivaroxaban Controls HemosIL Apixaban Controls Coamatic Protein C HemosIL Factor IX Deficient Plasma GEM Crit Check ContrIL 7 1, 2, 3 and Multipak HemosIL Factor XII Deficient Plasma HemosIL PCX/HPX Thromboplastin Diluent HemosIL SynthAFax HemosIL Routine Control Level 1 HemosIL Routine Control Level 3 HemosIL Routine Control Level 2 IL Crit PVP ChemSTAT Hematocrit Evaluator 2 ChemSTAT Hematocrit Evaluator 3 ChemSTAT Hematocrit Evaluator 1 GEM ChemSTAT critPVP 1-4 GEM Hematocrit Evaluator 1 GEM Hematocrit Evaluator 2 GEM Hematocrit Evaluator 3 Coatest Heparin HemosIL Dabigatran Calibrators HemosIL Rivaroxaban Calibrators HemosIL Apixaban Calibrators HemosIL Factor VII Deficient Plasma GEM HEMATOCRIT EVALUATOR 1, 2, 3 GEM SYSTEM EVALUATOR 1, 2, 3 GEM CVP 5 tBILI HemosIL Direct Thrombin Inhibitor Assay (0020302800) HemosIL Liquid Anti-Xa (Part No. 0020302601) HemosIL Protein C HemosIL SynthASil HemosIL Protein S Activity GEM Premier 5000 (Instrument) GEM Premier 5000 PAK HemosIL FII & FV DNA Control HemosIL Liquid Heparin HemosIL Heparin Calibrators HemosIL UF Heparin Controls HemosIL Liquid Anti-Xa HemosIL LMW Heparin Controls HemosIL von Willebrand Factor Antigen HemosIL Antithrombin HemosIL Thrombin Time HemosIL PT-Fibrinogen Calibration Plasma LMW Heparin HemosIL Factor V Deficient Plasma GEM CVP 2 with CO-OX (Orangeburg NY Facility) GEM CVP 3 Hematocrit (Orangeburg NY Facility) GEM CVP 1 with CO-OX (Orangeburg NY Facility) GEM CVP 5 tBili (Orangeburg NY Facility) GEM CVP 4 Hematocrit (Orangeburg NY Facility) GEM Premier 4000 PAK (Bedford MA Facility) GEM Premier 4000 (Bedford MA Facility) GEM Premier 7000 with iQM3 PAK GEM Premier 7000 with iQM3 HemosIL PT-Fibrinogen HS PLUS HemosIL Silica Clotting Time HemosIL Abnormal Control 3 HemosIL High Abnormal Control ASSAYED HemosIL Factor VIII Deficient Plasma ContrIL 9 Level 2 ContrIL 9 Multipak ContrIL 9 Level 3 ContrIL 9 Level 1 HemosIL Heparin HemosIL Special Test Control Level 2 HemosIL Special Test Control Level 1 HemosIL Chromogenic Factor IX HemosIL Factor X Deficient Plasma HemosIL Plasma Coagulation Control Level 1 HemosIL Plasma Coagulation Control Level 2 HemosIL D-Dimer Controls ROTROL P, ROTROL N HemosIL CL Multi-Ab Controls HemosIL Calibration Plasma HemosIL Normal Control 1 HemosIL Normal Control ASSAYED HemosIL ReadiPlasTin HemosIIL ProClot Diluent HemosIL ProClot GEM Premier 4000 HemosIL LA Positive Control HemosIL LA Negative Control HemosIL Liquid AT Substrate HemosIL Liquid Antithrombin IL PVP Multi-4 CO-Oximeter Control, Multi Avox-4 Co-Oximeter Control - L2 Multi-4 CO-Oximeter Control - Level 2 Avox-4 Co-Oximeter Control - L3 GEM ChemSTAT CVP 2 GEM ChemSTAT CVP 3 GEM ChemSTAT CVP 4 GEM ChemSTAT PVP 1-5 ChemSTAT System Evaluator 1 Avox-4 Co-Oximeter Control Multi-4 CO-Oximeter Control - Level 3 Avox-4 Co-Oximeter Control - L1 Multi-4 CO-Oximeter Control - Level 1 GEM ChemSTAT CVP 1 ChemSTAT System Evaluator 2 ChemSTAT System Evaluator 3 GEM CVP 5 tBili GEM System Evaluator 3 GEM System Evaluator 1 GEM System Evaluator 2 Coamatic Protein Free-S Coaset Factor VII HemosIL Low Fibrinogen Control ACL TOP 970 CL HemosIL ReadiPasTin Control Plasma LMW Heparin HemosIL Factor II Deficient Plasma Coamatic Heparin ISIweb HemosIL INR Validate HemosIL ISI Calibrate Coatest APC Resistance Control Plasma Level 1 Coatest APC Resistance Coatest APC Resistance Control Plasma Level 2 HemosIL RecombiPlasTin 2G (20 mL) COATEST SP FVIII COATEST SP4 FVIII

    Establishment Types

    Manufacture Medical Device Manufacture Device in the United States for Export Only Repack or Relabel Medical Device Develop Specifications But Do Not Manufacture At This Facility