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    FDA Registration Active 🇺🇸 United States

    Infrared Laboratory Systems dba SYNERMED

    Reg #: 3003593973 · FEI: 3003593973 · Expires 2026
    View on FDA
    Products
    41
    Proprietary Names
    80
    Establishment Types
    3
    Classifications
    41

    Registration Details

    Registration Name
    Infrared Laboratory Systems dba SYNERMED
    Registration Number
    3003593973
    FEI Number
    3003593973
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    17408 Tiller Ct Ste 1900
    City
    WESTFIELD
    State
    IN
    ZIP
    46074
    Country
    US

    Regulatory Submissions

    510(k) Number
    K931958

    Owner / Operator

    Firm Name
    Infrared Laboratory Systems, LLC
    Operator Number
    10038715
    Address
    17408 Tiller Court Suite 1900
    City
    Westfield
    State
    IN
    Postal Code
    46074
    Country
    US
    Correspondent
    Ulyana Koshelap

    Products

    Device Name Product Code
    Kinetic Method, Gamma-Glutamyl Transpeptidase JQB
    Calibrator, Multi-Analyte Mixture JIX
    Nadh Oxidation/Nad Reduction, Ast/Sgot CIT
    Photometric Method, Magnesium JGJ
    Diazo Colorimetry, Bilirubin CIG
    Nadh Oxidation/Nad Reduction, Alt/Sgpt CKA
    Acid, Uric, Uricase (Colorimetric) KNK
    Alkaline Picrate, Colorimetry, Creatinine CGX
    Glucose Oxidase, Glucose CGA
    Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes CJE
    Azo Dye, Calcium CJY
    Analyzer, Chemistry, Micro, For Clinical Use JJF
    Turbidimetric Method, Protein Or Albumin (Urinary, Non-Quant.) JIQ
    Biuret (Colorimetric), Total Protein CEK
    Phosphomolybdate (Colorimetric), Inorganic Phosphorus CEO
    Urease And Glutamic Dehydrogenase, Urea Nitrogen CDQ
    Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase CFJ
    Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides CDT
    Acid, Phosphoric-Tungstic (Spectrophotometric), Chloride CHG
    Enzymatic Esterase--Oxidase, Cholesterol CHH
    General Purpose Reagent PPM
    Drug Mixture Control Materials DIF
    Calibrators, Drug Mixture DKB
    Ferrozine (Colorimetric) Iron Binding Capacity JMO
    Electrode, Ion Specific, Sodium JGS
    Electrode, Ion-Specific, Chloride CGZ
    Electrode, Ion Specific, Potassium CEM
    Single (Specified) Analyte Controls (Assayed And Unassayed) JJX
    Ldl & Vldl Precipitation, Hdl LBR
    Cresolphthalein Complexone, Calcium CIC
    System, Test, Sodium, Enzymatic Method MZU
    Bathophenanthroline, Colorimetry, Iron (Non-Heme) CFM
    Calibrator, Secondary JIT
    Test, System, Potassium, Enzymatic Method MZV
    Analyzer, Chemistry (Photometric, Discrete), For Clinical Use JJE
    Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl LBS
    Bromcresol Green Dye-Binding, Albumin CIX
    Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes CGS
    Catalytic Methods, Amylase JFJ
    Preservative, Cytological LEA
    Enzymatic, Carbon-Dioxide KHS

    Proprietary Names

    VI410 Synermed GGT Reagent IR954 Synermed IR Cal II Multi Analyte Calibrator IR961-X Affirm 1 Multi Analyte Low Control IR962-X Affirm 2 Multi Analyte High Control UV085 AST Reagent IR170 Synermed Magnesium Reagent IR750 Direct Bilirubin Reagent UV185 ALT Reagent IR460 Synermed Uric Acid Reagent VI560 Synermed Creatinine Reagent Synermed IR500 Chemistry Analyzer IVD IR110 Synermed Phosphorus Reagent IR140 Synermed Triglycerides Reagent IR050 Synermed Chloride Reagent IR240 Synermed Calcium Reagent IR060 Synermed Cholesterol Reagent IR700 Total Bilirubin Reagent VI120 ALP-AMP Reagent DR-101-L Cellsolutions Density Reagent 1 Liter GCK-100-M CellSolutions Manual GluCyte Cytology Preparation Kit 100 tests and vials DR-101G CellSolutions Density Reagent 4x1 Liter GC-100E Cellsolutions GluCyte Cell Adherent 100mL GC1000E CellSolutions gluCyte Cell Adherent 1 Liter GCKI-500-M Cellsolutions Manual GluCyte Cytology Preparation Kit 500 tests GCKI-500-A CellSolutions Automated GluCyte Cytology Preparation Kit 500 tests GC-100NE Cellsolutions Manual GluCyte Cell Adherent 100mL GCI-25NE Cellsolutions Manual GluCyte Cell Sdherent 25mL GC-25NE CellSolutions Manual GluCyte Cell Adherent 25mL SS-250 Slideslick Glass Slide Cleaner GCI-100ANE CellSolutions Automated GluCyte Cell Adherent 100mL GCK-500-M CellSolutions Manual GluCyte Cytology Preparation Kit 500 tests GCI-100NE CellSolutions Manual GluCyte Cell Adherent 100mL GCK-500-A CellSolutions Automated GluCyte Cytology Preparation Kit 500 tests GCI-100E CellSolutions GluCyte Cell Adherent 100mL GCKI-100-M CellSolutions Manual GluCyte Cytology Preparation Kit 100 tests and vials GPR-0001 Synermed Negative DAU Calibrator IR150 Synermed UIBC Reagent UV190 Synermed Urea Nitrogen (BUN) Reagent ISE820 Synermed Olympus KCL 1 M Solution ISE810 Synermed Olympus ISE Mid Standard ISE800 Synermed Olympus ISE Buffer IR059 Synermed LDL-Cholesterol Reagent IR040 Synermed Calcium Reagent IR200 Automated Clinical Chemistry Analyzer IVD VI114 Synermed Sodium Reagent IR320 Synermed Serum Iron Reagent VI113 Synermed Potassium Reagent Synermed IR-1200 Automated Clinical Chemistry Analyzer IVD ISE720 Synermed Hitachi ISE Diluent ISE710 Synermed Hitachi ISE Internal Reference ISE730 Synermed Hitachi KCL 1 M Solution IR056 Synermed HDL-Cholesterol Reagent UV340 Synermed LDH Reagent IR010 Albumin Reagent UV310 Synermed Creatine Kinase Reagent VI400 Amylase Reagent VI135 Synermed Total Protein Reagent VI530 Synermed Total Protein Reagent CR-102G CellSolutions Red Lytic Genreal Cytology Preservative 4x1 Liter CBI-102G CellSolutions Blue Preservative 4x1 Liter BTA C-101A CellSolutions General Cytology Preservative 12.5 x concentrate CB-102G CellSolutions Blue Preservative 4x1 Liter BTA C-101B CellSolutions General Cytology Perservative 20 x concentrate CB-102-25 CellSolutions Blue Preservative 25 cups x 40mL CI-101-25 CellSolutions General Cytology Preservative Clamshell Case 25x10mL C-101-500 CellSolutions General Cytology Preservative 20 x 25 vials x 10mL CI-101-500 CellSolutions General Cytology Preservative 20 x 25 vials x 10mL C-101G CellSolutions General Cytology Preservative 4x1 Liter CR102L CellSolutions Red Lytic General Cytology Preservative 1 Liter C-101-200 CellSolutions General Sytology Preservative 8 x 25vials x 10mL CI-101L CellSolutions General Cytology Perservative 1 x Liter CBI-102-25 CellSolutions Blue Preservative 25 cups x40mL CI101-200 CellSolutions General Cytology Preservative 8 x 25 vials x 10mL CI-101G CellSolutions General Cytology Preservative 4x1 Liter CB-102L CellSolutions Blue Preservative 1 Liter C-101L CellSolutions General Cytology Preservative 1 Liter CBI-102L CellSolutions Blue Preservative 1 Liter C-101-25 CellSolutions General Cytology Preservative Clamshell Case 25 vials x 10mL IR070 Synermed Glucose Reagent UV380 Synermed CO2 Reagent

    Establishment Types

    Manufacture Medical Device Manufacture Medical Device for Another Party (Contract Manufacturer) Repack or Relabel Medical Device