BEUDAMED
    FDA Registration Active 🇺🇸 United States

    INSTRUMENTATION LABORATORY CO. - Devens

    Reg #: 3037000637 · FEI: 3037000637 · Expires 2026
    View on FDA
    Products
    53
    Proprietary Names
    219
    Establishment Types
    2
    Classifications
    53

    Registration Details

    Registration Name
    INSTRUMENTATION LABORATORY CO. - Devens
    Registration Number
    3037000637
    FEI Number
    3037000637
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    11 Grant Road
    City
    Devens
    State
    MA
    ZIP
    01434
    Country
    US

    Regulatory Submissions

    510(k) Number
    K833891

    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
    Assay, Heparin KFF
    Plasma, Coagulation Control GGN
    Test, Qualitative And Quantitative Factor Deficiency GGP
    Assay, Oral Direct Thrombin Inhibitor QBG
    System, Multipurpose For In Vitro Coagulation Studies JPA
    Instrument, Coagulation, Automated GKP
    Platelet Factor 4 Radioimmunoassay LCO
    Glucose Oxidase, Glucose CGA
    Bilirubin (Total And Unbound) In The Neonate Test System MQM
    System, Hemoglobin, Automated GKR
    Assay, Carboxyhemoglobin GHS
    Electrode, Ion-Specific, Chloride CGZ
    Instrument, Hematocrit, Automated GKF
    Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph CHL
    Electrode, Ion Specific, Potassium CEM
    Oximeter To Measure Hemoglobin GLY
    Electrode, Ion Specific, Calcium JFP
    Electrode, Ion Specific, Sodium JGS
    Acid, Lactic, Enzymatic Method KHP
    Test, Time, Partial Thromboplastin GGW
    System,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi) MSV
    System, Test, Anticardiolipin Immunological MID
    Plasma, Coagulation Factor Deficient GJT
    Calibrator, Multi-Analyte Mixture JIX
    System, Fibrinogen Determination KQJ
    Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control DAP
    Calculator/Data Processing Module, For Clinical Use JQP
    Calibrator, Primary JIS
    Single (Specified) Analyte Controls (Assayed And Unassayed) JJX
    Calibrators, Drug Specific DLJ
    Anti-Factor Xa Activity Test System, Apixaban QLU
    Multi-Analyte Controls, All Kinds (Assayed) JJY
    Antithrombin Iii Quantitation JBQ
    Analyzer, Chemistry (Photometric, Discrete), For Clinical Use JJE
    Control, Hematocrit GLK
    Test, Thrombin Time GJA
    Test, Fibrinogen GIS
    Fluorometric, Calcium JFO
    Test, Time, Prothrombin GJS
    Drug Specific Control Materials LAS
    Plasma, Control, Normal GIZ
    Control, Plasma, Abnormal GGC
    Reagent, Russel Viper Venom GIR
    Calibrator, Secondary JIT
    Medical Device Data System OUG
    Activated Partial Thromboplastin GFO
    Antiserum, Positive Control, Aspergillus Spp. KFG
    Diazo Colorimetry, Bilirubin CIG
    Factor Xiii A, S, Antigen, Antiserum, Control DBT
    Enzymatic Method, Creatinine JFY
    Urease And Glutamic Dehydrogenase, Urea Nitrogen CDQ
    Enzymatic, Carbon-Dioxide KHS
    Urinary Homocystine (Nonquantitative) Test System LPS

    Proprietary Names

    Coatest Heparin HemosIL Normal Control 1 HemosIL Normal Control ASSAYED HemosIL Chromogenic Factor IX HemosIL Direct Thrombin Inhibitor Assay (0020302800) HemosIL Liquid Anti-Xa (Part No. 0020302601) ROTEM sigma ROTROL N ROTEM sigma complete + hep ROTEM sigma ROTROL P ROTEM sigma Thromboelastometry System HemosIL Plasminogen HemosIL Heparin ACL TOP 750 LAS ACL TOP 550 CTS ACL TOP 750 CTS ACL TOP 750 ACL TOP 350 CTS HemosIL HIT-Ab(PF4-H) Controls HemosIL HIT-Ab(PF4-H) GEM Premier 7000 with iQM3 PAK GEM Premier 7000 with iQM3 ACL TOP 970 CL Coatest APC Resistance Control Plasma Level 1 Coatest APC Resistance Coatest APC Resistance Control Plasma Level 2 HemosIL CL Anti-B2 Glycoprotein-I IgM HemosIL CL Anti-Cardiolipin IgM HemosIL Factor V Deficient Plasma HemosIL Factor XII Deficient Plasma HemosIL Plasmin Inhibitor Coamatic Protein Free-S Coaset Factor VII HemosIL Calibration Plasma HemosIL Fibrinogen-C HemosIL Fibrinogen-C XL HemosIL D-Dimer HS 500 Controls ISIweb HemosIL INR Validate HemosIL ISI Calibrate ACL TOP 300 CTS ACL TOP CTS (Refurb) ACL TOP 500 CTS ACL TOP 700 (Refurb) ACL TOP 700 CTS ACL TOP 700 ACL TOP 700 LAS ACL TOP 700 CTS (Refurb) ACL TOP 500 CTS (Refurb) ACL TOP 300 CTS (Refurb) HemosIL AcuStar Anti-B2 Glycoprotein-I IgG Controls HemosIL AcuStar Anti-B2 Glycoprotein-I IgG HemosIL AcuStar Anti-B2 Glycoprotein-I IgM HemosIL AcuStar Anti-B2 Glycoprotein-I IgM Controls ELECTRACHROME Factor VIII Coamatic Factor VIII HemosIL Apixaban Calibrators HemosIL Liquid Anti-Xa COATEST SP FVIII COATEST SP4 FVIII HemosIL Protein S Activity HemosIL Plasma Coagulation Control Level 1 HemosIL Plasma Coagulation Control Level 2 HemosIL Rivaroxaban Controls HemosIL Apixaban Controls HemosIL Dabigatran Controls 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 HemosIL Free Protein S HemosIL Liquid AT Substrate HemosIL Liquid Antithrombin HemosIL Routine Control Level 1 HemosIL Routine Control Level 3 HemosIL Routine Control Level 2 GEM HEMATOCRIT EVALUATOR 1, 2, 3 GEM SYSTEM EVALUATOR 1, 2, 3 GEM CVP 5 tBILI HemosIL Q.F.A. Thrombin (Bovine) HemosIL Special Test Control Level 2 HemosIL Special Test Control Level 1 HemosIL Dabigatran Calibrators HemosIL Rivaroxaban Calibrators GEM CVP 4 GEM CVP 1 GEM CVP Multipak GEM CVP 3 GEM Premier 3000 PAK GEM Premier 3500/3000 PAK GEM CVP 2 ACL TOP 770 LAS ACL TOP 570 ACL TOP 770 ACL TOP 770s GEM Premier 5000 PAK Calibration Plasma LMW Heparin HemosIL von Willebrand Factor Antigen GEM Crit Check ContrIL 7 1, 2, 3 and Multipak HemosIL PT-Fibrinogen HS PLUS HemosIL Factor V Leiden HemosIL Factor V Reagent Plasma Coatest APC Resistance V S Coatest APC Resistance V HemosIL Abnormal Control 3 HemosIL High Abnormal Control ASSAYED GEM Premier 5000 (Instrument) HemosIL Factor IX Deficient Plasma HemosIL AcuStar D-Dimer HemosIL AcuStar D-Dimer Controls AcuStar BIO-FLASH HemosIL von Willebrand Factor Activity HemosIL Factor VIII Deficient Plasma HemosIL Abnormal Control 2 HemosIL Low Abnormal Control ASSAYED HemosIL LA Positive Control HemosIL LA Negative Control NATEM Assay ROTROL N ROTEM Delta Instrument hep-TEM Assay star-TEM ROTROL P in-TEM Assay HemosIL D-Dimer HemosIL dRVVT Screen HemosIL dRVVT Confirm HemosIL Factor X Deficient Plasma HemosIL Low Fibrinogen Control HemosIL CL HIT-IgG(PF4-H) EX-TEM. FIB-TEM, AND AP-TEM FOR ROTEM DELTA THROMBOELASTOMET HemosIL D-Dimer HS 500 ContrIL 9 Level 2 ContrIL 9 Multipak ContrIL 9 Level 3 ContrIL 9 Level 1 Coamatic Heparin Coamatic Protein C HemosIL Thrombin Time HemosIL PT-Fibrinogen HemosIL AcuStar Anti-B2GPI Domain 1 HemosIL Factor VII Deficient Plasma HemosIL RecombiPlasTin 2G (20 mL) HemosIL Protein C HemosIL AcuStar Anti-Cardiolipin IgG Controls HemosIL AcuStar Anti-Cardiolipin IgG HemosIL AcuStar Anti-Cardiolipin IgM Controls HemosIL AcuStar Anti-Cardiolipin IgM HemosIL Factor XI Deficient Plasma GEMweb Plus 300 GEMweb GEMweb Plus 400 GEMweb Plus 100 GEMweb Plus 200 HemoHub GEMweb Plus 450 GEMweb Plus 500 HemosIL Silica Clotting Time HemosIL D-Dimer Controls ROTROL P, ROTROL N HemosIL CL Multi-Ab Controls HemosIL AcuStar HIT-IgG(PF4-H) HemosIL AcuStar HIT Controls ACL ELITE PRO ACL ELITE (Refurb) ACL ELITE Pro (Refurb) ACL ELITE GEM Premier 3500 HemosIL ReadiPlasTin HemosIL D-Dimer HS HemosIL SynthASil 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 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) HemosIL RecombiPlasTin 2G (8 mL) GEM Premier 5000 PAK (with added capillary claims) HEMOSIL FACTOR XIII ANTIGEN HemosIL SynthAFax HemosIL Liquid Heparin HemosIL Heparin Calibrators HemosIL UF Heparin Controls HemosIL LMW Heparin Controls GEM Premier 4000 GEM Premier ChemSTAT GEM Premier ChemSTAT PAK HemosIL Homocysteine Controls HemosIL Homocysteine HemosIIL ProClot Diluent HemosIL ProClot

    Establishment Types

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