BEUDAMED
    FDA Registration Active 🇺🇸 United States

    INSTRUMENTATION LABORATORY CO.

    Reg #: 1217183 · FEI: 1217183 · Expires 2026
    View on FDA
    Products
    45
    Proprietary Names
    202
    Establishment Types
    4
    Classifications
    45

    Registration Details

    Registration Name
    INSTRUMENTATION LABORATORY CO.
    Registration Number
    1217183
    FEI Number
    1217183
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    180 Hartwell Rd.
    City
    Bedford
    State
    MA
    ZIP
    01730
    Country
    US

    Regulatory Submissions

    510(k) Number
    K042423

    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
    System, Automated Platelet Aggregation JOZ
    System, Multipurpose For In Vitro Coagulation Studies JPA
    Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control DAP
    Test, Qualitative And Quantitative Factor Deficiency GGP
    Multi-Analyte Controls, All Kinds (Assayed) JJY
    Control, Hematocrit GLK
    Bilirubin (Total And Unbound) In The Neonate Test System MQM
    Diazo Colorimetry, Bilirubin CIG
    Electrode, Ion-Specific, Chloride CGZ
    Electrode, Ion Specific, Sodium JGS
    Glucose Oxidase, Glucose CGA
    Oximeter To Measure Hemoglobin GLY
    Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph CHL
    System, Hemoglobin, Automated GKR
    Acid, Lactic, Enzymatic Method KHP
    Instrument, Hematocrit, Automated GKF
    Assay, Carboxyhemoglobin GHS
    Electrode, Ion Specific, Calcium JFP
    Electrode, Ion Specific, Potassium CEM
    Plasma, Coagulation Control GGN
    Analyzer, Chemistry (Photometric, Discrete), For Clinical Use JJE
    Single (Specified) Analyte Controls (Assayed And Unassayed) JJX
    System,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi) MSV
    Urinary Homocystine (Nonquantitative) Test System LPS
    Factor Xiii A, S, Antigen, Antiserum, Control DBT
    Assay, Heparin KFF
    Activated Whole Blood Clotting Time JBP
    Enzymatic Method, Creatinine JFY
    Urease And Glutamic Dehydrogenase, Urea Nitrogen CDQ
    Enzymatic, Carbon-Dioxide KHS
    Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature FMK
    Instrument, Coagulation, Automated GKP
    Protamine Sulphate GFT
    Platelet Factor 4 Radioimmunoassay LCO
    Device, Bleeding Time JCA
    Test, Time, Prothrombin GJS
    Activated Partial Thromboplastin GFO
    System, Fibrinogen Determination KQJ
    System, Test, Anticardiolipin Immunological MID
    Spectral Absorb. Curve, Oxyhemoglobin, Carboxyhemoglobin, Carbon-Monoxide JKS
    Oximeter DQA
    Fiber, Medical, Absorbent FRL
    Medical Device Data System OUG
    Instrument, Coagulation KQG
    Antiserum, Positive Control, Aspergillus Spp. KFG

    Proprietary Names

    85053-10 - Aspirin Test 85053 - Aspirin Test HE-ESV - Electronic System Verification Tube HR1003 - Temperature Verification Tube HemosIL D-Dimer HemosIL von Willebrand Factor Activity GEM Premier 4000 GEM Premier 5000 (Instrument) GEM Premier 5000 PAK HemosIL Apixaban Controls HemosIL D-Dimer Controls ROTROL P, ROTROL N HemosIL Rivaroxaban Controls HemosIL CL Multi-Ab Controls GEM Premier ChemSTAT GEM Premier ChemSTAT PAK 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 HemosIL Homocysteine Controls HemosIL Homocysteine HEMOSIL FACTOR XIII ANTIGEN HemosIL Plasma Coagulation Control Level 1 HemosIL Plasma Coagulation Control Level 2 HemosIL Dabigatran Controls 85310 - IIb/IIIa Test J103 - APTT Cuvettes R-HRT480P - Heparin Response Test RQCHRT - RxDx Whole Blood Quality Control Heparin HemosIL Chromogenic Factor IX HemosIL Free Protein S HemosIL D-Dimer HS GH100L - GEM Hemochron 100 System GH100 - GEM Hemochron 100 System HE-J04 - Hemochron Electronic System Verification Kit JEN-QC - Hemochron Electronic System Verification, Normal JEA-QC - Hemochron Electronic System Verification, Abnormal HRDM3CD - Hemochron Data Manager V3 J-1001 - Hemochron Temperature Verification Cartrdige ROTEM sigma ROTROL N ROTEM sigma complete + hep ROTEM sigma ROTROL P ROTEM sigma Thromboelastometry System TL100I - Tenderlett Finger Incision Device TL5000I - Tenderlett Finger Incision Device ACL AcuStar ACL TOP 970 CL HemosIL von Willebrand Factor Antigen 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) R-PRT200 - Celite Protamine Response Test RQCPRT - RxDx Whole Blood Quality Control Protamine R-PRT400 - Celite Protamine Response Test 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 CL HIT-IgG(PF4-H) HemosIL D-Dimer HS 500 Controls NATEM Assay ROTROL N ROTEM Delta Instrument hep-TEM Assay star-TEM ROTROL P in-TEM Assay SU50I - Surgicutt Bleeding Time Device R-PRT200K - Kaolin Protamine Response Test R-PRT400K - Kaolin Protamine Response Test PDAOK - Kaolin Protamine Dose Assay R-HRT480PK - Kaolin Heparin Response Test DCJLR-N - directCHECK ACT-LR-Normal DCJLR-A - directCHECK ACT-LR-Abnormal DCJ-005 - Protective Sleeves DCJACT-A - directCHECK ACT+-Abnormal DCJACT-N - directCHECK ACT+-Normal GEM ChemSTAT HemosIL AcuStar D-Dimer HemosIL AcuStar D-Dimer Controls AcuStar BIO-FLASH J201 - PT Cuvettes J201C - Citrate PT Cuvettes J103C - Citrate APTT Cuvettes 85064 - P2Y12 Test, International 85425 - P2Y12 Test, International 85064-PRO - P2Y12 Test, International HemosIL AcuStar Anti-B2GPI Domain 1 Control Test Tube HemosIL Fibrinogen-C HemosIL Fibrinogen-C XL DCJCAPTT-A - directCHECK Citrate APTT-Abnormal DCP214-N - HepCheck P214-Normal DCJAPTT-A - directCHECK APTT-Abnormal DCP214-A - HepCheck P214-Abnormal DCJPT-N - directCHECK PT-Normal DCJAPTT-N - directCHECK APTT-Normal DCJPT-A - directCHECK PT-Abnormal DCJCPT-N - directCHECK Citrate PT-Normal DCJCPT-A - directCHECK Citrate PT-Abnormal HemosIL AcuStar HIT-IgG(PF4-H) HemosIL AcuStar HIT Controls HemosIL CL Anti-B2 Glycoprotein-I IgM HemosIL CL Anti-Cardiolipin IgM PDAO - Celite Protamine Dose Assay HemosIL AcuStar Anti-Cardiolipin IgG Controls HemosIL AcuStar Anti-Cardiolipin IgG HemosIL AcuStar Anti-Cardiolipin IgM Controls HemosIL AcuStar Anti-Cardiolipin IgM JACT+ - ACT+ Cuvettes TFP50I - Tenderfoot Preemie Heel Incision Device TF1000I - Tenderfoot Newborn Heel Incision Device TFP1000I - Tenderfoot Preemie Heel Incision Device TF50I - Tenderfoot Newborn Heel Incision Device TFT50I - Tenderfoot Toddler Heel Incision Device TF200I - Tenderfoot Newborn Heel Incision Device TFM50I - Tenderfoot Micro-Preemie Heel Incision Device TFP200I - Tenderfoot Preemie Heel Incision Device GEM CVP 4 GEM CVP 1 GEM CVP Multipak GEM CVP 3 GEM Premier 3000 PAK GEM Premier 3500/3000 PAK GEM CVP 2 AVOX4000D - Whole Blood CO-Oximeter Instrument AVOX4000RF - Whole Blood CO-Oximeter Instrument 4-QCYO - Whole Blood CO-Oximeter Optical QC Filters AVOX4000 - Whole Blood CO-Oximeter Instrument QV8 - Avoximeter 4000 Cuvettes 4-TMPB - Whole Blood CO-Oximeter Temperature Probe AVOX1000ERF - Whole Blood Oximeter Instrument AVOX1000ED - Whole Blood Oximeter Instrument AVOX1000E - Whole Blood Oximeter Instrument AVOX1000EL - Whole Blood Oximeter Instrument C100B - Avoximeter 1000E Cuvettes E-QCYO - Whole Blood Oximeter Optical QC Filters SUP100I - Surgicutt Blotting Paper HRFTK-ACT - Kaolin ACT Tubes ACL ELITE PRO ACL ELITE (Refurb) ACL ELITE Pro (Refurb) ACL ELITE GEM Premier 7000 with iQM3 PAK GEM Premier 7000 with iQM3 EX-TEM. FIB-TEM, AND AP-TEM FOR ROTEM DELTA THROMBOELASTOMET JACT-LR - ACT-LR Cuvettes 85047 - WQC 86003L - VerifyNow Instrument 86003 - VerifyNow Instrument 86003D - VerifyNow Instrument 86000 - VerifyNow Instrument 70068 - EQC 86000L - VerifyNow Instrument 86000RF - VerifyNow Instrument 86000D - VerifyNow Instrument 85062 - Preventative Maintenance Kit 85063 - Validation Kit GEMweb Plus 300 GEMweb GEMweb Plus 400 GEMweb Plus 100 GEMweb Plus 200 HemoHub GEMweb Plus 450 GEMweb Plus 500 85225 - PRUTest HemosIL D-Dimer HS 500 GEM Premier 5000 PAK (with added capillary claims) HRS.110 - Hemochron Response Instrument HRS.110D - Hemochron Response Instrument HRS.110L - Hemochron Response Instrument HRS.RF - Hemochron Response Instrument ACL TOP 770 LAS ACL TOP 570 ACL TOP 770 ACL TOP 770s GEM Premier 3500 ELITEL - Hemochron ELITE Instrument ELITEDEMO - Hemochron ELITE Instrument RPM-CD - Report Maker V61 ELITE - Hemochron ELITE Instrument ELITERF - Hemochron ELITE Instrument ACL TOP 750 CTS ACL TOP 550 CTS ACL TOP 750 LAS ACL TOP 750 ACL TOP 350 CTS HemosIL HIT-Ab(PF4-H) Controls HemosIL HIT-Ab(PF4-H)

    Establishment Types

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