BEUDAMED
    FDA Registration Active 🇮🇹 Italy

    INSTRUMENTATION LABORATORY SPA

    Reg #: 3012348571 · FEI: 3012348571 · Expires 2026
    View on FDA
    Products
    38
    Proprietary Names
    254
    Establishment Types
    1
    Classifications
    38

    Registration Details

    Registration Name
    INSTRUMENTATION LABORATORY SPA
    Registration Number
    3012348571
    FEI Number
    3012348571
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Via Leonardo da Vinci, 36
    City
    Roncello Lombardy
    Country
    IT

    Regulatory Submissions

    510(k) Number
    K052262

    Owner / Operator

    Firm Name
    Instrumentation Laboratory SpA
    Operator Number
    10082968
    Address
    Viale Monza 338
    City
    Milan
    State
    Lombardy
    Postal Code
    20128
    Country
    IT
    Correspondent
    Natale Bova

    Products

    Device Name Product Code
    Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control DBM
    Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control DBL
    Single (Specified) Analyte Controls (Assayed And Unassayed) JJX
    Calibrator, Secondary JIT
    Extractable Antinuclear Antibody, Antigen And Control LLL
    Test System, Antineutrophil Cytoplasmic Antibodies (Anca) MOB
    Calibrator, Multi-Analyte Mixture JIX
    Autoantibodies, Endomysial(Tissue Transglutaminase) MVM
    System, Test, Anticardiolipin Immunological MID
    Instrumentation For Clinical Multiplex Test Systems NSU
    Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control DHN
    System,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi) MSV
    Antibodies, Anti-Cyclic Citrullinated Peptide (Ccp) NHX
    System, Multipurpose For In Vitro Coagulation Studies JPA
    Autoantibodies, Nuclear Pore Glycoprotein Gp210 NRI
    Autoantibodies, Nuclear Body Protein, Sp100 NUM
    Enzyme Immunoassay, Antiparietal Cell Antibody, Antigen, Control MLE
    Helicobacter Pylori LYR
    Antibodies, Gliadin MST
    Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls LJM
    Autoantibodies, Lkm-1 (Liver/Kidney Microsome, Type 1) NBS
    Automated Indirect Immunofluorescence Microscope And Software-Assisted System For Clinical Use PIV
    Antibodies, Saccharomyces Cerevisiae (S.Cerevisiae) NBT
    System, Test, Rheumatoid Factor DHR
    Anti-Ribosomal P Antibodies MQA
    Autoantibodies, Anti-Soluble Liver Antigen (Sla), Autoimmune Hepatitis NIY
    Anti-Dna Antibody (Enzyme-Labeled), Antigen, Control LRM
    Anti-Ss-A 52 Autoantibodies OBE
    Devices, Measure, Antibodies To Glomerular Basement Membrane (Gbm) MVJ
    Anti-Sm Antibody, Antigen And Control LKP
    Anti-Rnp Antibody, Antigen And Control LKO
    Antibodies, Anti-Actin, Anti-Smooth Muscle NJF
    Auto-Antibodies; Phosphatidylserine, Prothrombin, Phosphatidylserine/Prothrombin Complex OPN
    Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature FMK
    Complement C1q, Antigen, Antiserum, Control DAK
    Oximeter DQA
    Thyroglobulin, Antigen, Antiserum, Control DDC
    Plasma, Coagulation Control GGN

    Proprietary Names

    QUANTA Lite M2 EP (MIT3) ELISA QUANTA Lite M2 EP (MIT3) ELISA Bulk Pack QUANTA Lite M2 EP (MIT3) NOVA Lite Rat Liver,Kidney,Stomach NOVA Lite Rat Liver, Kidney, Stomach Kit QUANTA Flash Jo-1 Reagents QUANTA Flash Jo-1 Controls QUANTA Flash Jo-1 QUANTA Flash Jo-1 Calibrators Auto AB Panel NOVA Lite Autoantibody Controls NOVA Lite Auto AB Panel QUANTA Lite PR3 SC ELISA QUANTA Lite PR3 SC ELISA Bulk Pack QUANTA Flash h-tTG IgA Calibrators QUANTA Flash h-tTG IgA Reagents QUANTA Flash h-tTG IgA Controls QUANTA Flash h-tTG IgA QUANTA Lite ACA IgA III QUANTA Lite ACA IgA ELISA Bulk Pack Aptiva System Rinse Aptiva System Cleaning Solution kit QUANTA Lite F-Actin IgA ELISA QUANTA Lite ANA ELISA NOVA Lite ANA KSL NOVA Lite ANA KSL Kit QUANTA Lite B2 GPI IgA ELISA Bulk Pack QUANTA Lite B2 GPI IgA ELISA QUANTA Lite ENA 5 ELISA Sm,RNP,SS-A,SS-B and Scl-70 Screening Test QUANTA Lite PR-3 IgG ELISA QUANTA Flash CCP3 Reagents QUANTA Flash CCP3 Controls QUANTA Flash CCP3 QUANTA Flash CCP3 Calibrators fib-tem ex-tem ap-tem QUANTA Lite CCp3.1 IgG/IgA ELISA Bulk Pack QUANTA Lite CCP3.1 IgG/IgA ELISA QUANTA Lite PBC Screen IgG/IgA ELISA QUANTA Lite B2 GPI Screening ELISA Bulk Pack QUANTA Lite B2 GPI Screening ELISA QUANTA Lite ds DNA ELISA double stranded DNA ELISA QUANTA Lite dsDNA ELISA QUANTA Flash ENA7 Reagent Kit QUANTA Flash ENA7 Calibrator Kit QUANTA Flash ENA7 Calibrators QUANTA Flash ENA7 Controls QUANTA Flash ENA7 Reagents QUANTA Flash ENA7 Control Kit QUANTA Lite Phosphatidylserine IgM ELISA QUANTA Lite Phosphatidylserine IgA ELISA QUANTA Lite Phosphatidylserine IgM ELISA Bulk Pack QUATNA Lite Phosphatidylserine IgM ELISA Bulk Pack QUANTA Lite Phosphatidylserine IgG ELISA Bulk Pack QUANTA Lite Phosphatidylserine IgG ELISA QUANTA Lite Sm ELISA QUANTA LIte GPA (Gastric Parietal Cell Antibody) ELISA QUANTA Lite GPA ELISA (Gastric Parietal Cell Antibody) QUANTA Lite GPA ELISA QUANTA Lite H. pylori IgA ELISA NOVA Lite Monkey Oesophagus IFA Kit QUANTA Lite Celiac DGP Screen QUANTA Lite Celiac DGP Screen ELISA QUANTA Lite ACA IgG III ELISA Bulk Pack QUANTA Lite ACA IgG III QUANTA Flash B2 GP1 IgA Reagents QUANTA Flash Cardiolipin IgA QUANTA Flash Cardiolipin IgA Reagents QUANTA Flash Cardiolipin IgA Controls QUANTA Flash B2 GP1 IgA Controls QUANTA Flash aCL IgA Controls QUANTA Flash B2 GP1 IgA QUANTA Flash aCL IgA Reagents QUANTA Flash aCL IgA NOVA Lite HEp-2 ANA Kit QUANTA Flash Ro60 Calibrators QUANTA Flash Ro60 Controls QUANTA Flash Ro60 Reagents QUANTA Lite H. pylori IgG ELISA QUANTA Lite B2GP1 IgG ELISA Bulk Pack QUANTA Lite B2GPI IgG ELISA QUANTA Lite CCP3 IgG ELISA Bulk Pack QUANTA Lite CCP3 IgG ELISA NOVA Lite ANCA (Formalin Fixed) Anti-neutrophil Cytoplasmic Autoantibody Reagents NOVA Lite ANCA Substrate Slide Pack NOVA Lite ANCA (Formalin) Kit with DAPI NOVA Lite ANCA Formalin Kit QUANTA Flash Centromere Calibrators QUANTA Flash Centromere Reagents QUANTA Flash Centromere Controls QUANTA Lite Gliadin IgG ELISA Bulk Pack QUANTA Lite Gliadin IgG ELISA QUANTA Lite LKM-1 ELISA QUANTA Flash h-tTG QUANTA Flash h-tTG IgG Calibrators QUANTA Flash h-tTG IgG Controls QUANTA Flash h-tTG IgG Reagents QUANTA Lite tTG ELISA QUANTA Lite tTG ELISA (TissueTransglutaminase) NOVA Lite DAPI ANA Kit NOVA View Automated Fluorescence Microscope with AUTOLoader NOVA View NOVA View Automated Fluorescence Microscope QUANTA Lite ASCA IgA ELISA (S. cerevisiae) QUANTA LIte ASCA (S. cerevisiae) IgA QUANTA Lite ASCA IgA ELISA QUANTA Lite B2 GPI IgM ELISA Bulk Pack QUANTA Lite B2 GPI IgM ELISA QUANTA Lite Histone ELISA QUANTA Lite RF IgA ELISA QUANTA Lite Chromatin ELISA QUANTA Lite Ribosome P ELISA QUANTA Lite IgG II QUANTA LIte Gliadin IgG II ELISA Bulk Pack QUANTA Lite Gliadin IgG II ELISA QUANTA Lite Gliadin IgA ELISA QUANTA Lite Gliadin IgA ELISA Bulk Pack QUANTA Lite ENA 4 QUANTA Lite ENA 4 ELISA QUANTA Lite ENA 4 ELISA Sm,RNP, SS-A and SS-B Screening Test QUANTA Lite SLA QUANTA Lite SLA ELISA QUANTA Lite SLA ELISA (Soluble Liver Antigen) QUANTA Lite dsDNA SC ELISA QUANTA Flash Ro52 Controls QUANTA Flash Ro52 Calibrators QUANTA Flash Ro52 Reagents QUANTA Flash Ro52 QUANTA Flash GBM Controls QUANTA Flash GBM Reagents QUANTA Flash GBM Calibrators QUANTA Flash MPO Calibrators QUANTA Flash MPO Reagents QUANTA Flash PR3 Calibrators QUANTA Flash PR3 QUANTA Flash GBM QUANTA Flash MPO QUANTA Flash MPO Controls QUANTA Flash PR3 Reagents QUANTA Flash PR3 Controls BIO-FLASH System Rinse HemosIL Acustar System Rinse QUANTA Lite RF IgG ELISA QUANTA Lite h-tTG/DGP Screen QUANTA Lite h-tTG/DGP Screen ELISA QUANTA Lite SS-A ELISA HemosIL AcuStar Anti-Cardiolipin IgM Controls HemosIL AcuStar Anti-Cardiolipin IgG HemosIL AcuStar Anti-Cardiolipin IgG Controls HemosIL AcuStar Anti-Cardiolipin IgM QUANTA Flash aCL IgG QUANTA Flash aCL IgM QUANTA Flash aCL IgG Reagents QUANTA Flash aCL IgM Reagents QUANTA Flash aCL IgM Controls QUANTA Flash aCL IgG Controls QUANTA Lite HA dsDNA ELISA QUANTA Lite RF IgM ELISA NOVA Lite ANA Plus NOVA Lite ANA Plus Mouse Kidney & Stomach QUANTA Lite h-tTG IgA ELISA Bulk Pack QUANTA Lite h-tTG IgA ELISA QUANTA Flash Sm Controls QUANTA Flash RNP Reagents QUANTA Flash RNP Calibrators QUANTA Flash Sm Reagents QUANTA Flash Sm Calibrators QUANTA Flash RNP Controls QUANTA Lite Jo-1 ELISA QUANTA Flash SSB Reagents QUANTA Flash SSB Calibrators QUATNA Flash SS-B Reagents QUATNA Flash SSB Controls QUANTA Flash SS-B Controls QUATNA Flash SS-B Calibrators QUANTA Lite Actin IgG ELISA QUANTA Lite Actin IgG ELISA Bulk Pack QUANTA Lite RNP ELISA QUANTA Lite R h-tTG IgG ELISA Bulk Pack QUANTA Lite R h-tTG IgA ELISA QUANTA Lite R h-tTG IgG ELISA QUANTA Lite R h-tTG IgA ELISA Bulk Pack QUANTA Lite gp210 QUANTA Lite gp210 ELISA QUANTA Lite Scl-70 ELISA QUANTA Lite aPS/PT IgG ELISA QUANTA Lite aPS/PT IgM ELISA (anti-phosphatidylserineand prothombin) HemosIL AcuStar Anti-B2 Glycoprotein-I IgM HemosIL AcuStar Anti-B2 Glycoprotein-I IgG HemosIL AcuStar Anti-B2 Glycoprotein-I IgG Controls QUANTA Flash B2GP1 IgG Reagents QUANTA Flash B2GP1 IgM QUANTA Flash B2GP1 IgM Reagents QUANTA Flash B2GP1 IgG QUANTA Flash B2GP1 IgM Controls QUANTA Flash B2GP1 IgG Controls QUANTA Lite Centromere ELISA Sm,RNP,SS-A,SS-B,Scl-70 & Jo-1 Screening Test QUANTA Lite ENA 6 ELISA QUANTA Lite ASCA IgG ELISA (S. cerevisiae) QUANTA Lite ASCA (S.cerevisiae) IgG QUANTA Lite ASCA IgG ELISA TFP50I - Tenderfoot Preemie Heel Incision Device TFM50I - Tenderfoot Micro-Preemie Heel Incision Device TF1000I - Tenderfoot Newborn Heel Incision Device TF50I - Tenderfoot Newborn Heel Incision Device TFP200I - Tenderfoot Preemie Heel Incision Device TFP1000I - Tenderfoot Preemie Heel Incision Device TF200I - Tenderfoot Newborn Heel Incision Device TFT50I - Tenderfoot Toddler Heel Incision Device QUANTA Lite C1q CIC ELISA NOVA Lite ANCA (Ethanol Fixed) NOVA Lite ANCA Kit NOVA Lite ANCA QUANTA Lite SS-B ELISA QUANTA Flash DGP Screen Reagents QUANTA Flash DGP Screen QUANTA Flash DGP Screen Controls QUANTA Flash DGP Screen Calibrators QUANTA Lite h-tTG Screen ELISA QUANTA Lite h-tTG Screen QUANTA Lite GBM ELISA Bulk Pack QUANTA Lite GBM ELISA AVOX1000E - Whole Blood Oximeter Instrument QUANTA Lite Thyroid T ELISA QUANTA Lite h-tTG IgG ELISA (Human Tissue Transglutaminase) QUANTA Lite h-tTG IgG ELISA Bulk Pack QUANTA Lite h-tTG IgG ELISA Hemochron Signature Elite NOVA Lite dsDNA Crithidia luciliae NOVA Lite dsDNA QUANTA Lite MPO IgG ELISA QUANTA Flash DGP IgA Reagents QUANTA Flash DGP IgG Reagents QUANTA Flash DGP IgA Controls QUANTA Flash DGP IgG Calibrators QUANTA Flash DGP IgA Calibrators QUANTA Flash DGP IgG Controls star-tem ROTROL P ROTROL N in-tem ROTEM Delta System hep-tem QUANTA Lite TPO ELISA QUANTA Lite ACA Screen III QUANTA Lite ACA IgM III ELISA Bulk Pack QUANTA Lite ACA IgM III QUANTA Lite Gliadin IgA II ELISA QUANTA Lite Gliadin IgA II ELISA Bulk Pack

    Establishment Types

    Export Device to the United States But Perform No Other Operation on Device