BEUDAMED
    FDA Registration Active 🇺🇸 United States

    High Technology, Inc.

    Reg #: 3013660430 · FEI: 3013660430 · Expires 2026
    View on FDA
    Products
    64
    Proprietary Names
    165
    Establishment Types
    3
    Classifications
    64

    Registration Details

    Registration Name
    High Technology, Inc.
    Registration Number
    3013660430
    FEI Number
    3013660430
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    20 Alice Agnew Dr
    City
    North Attleboro
    State
    MA
    ZIP
    02763
    Country
    US

    Owner / Operator

    Firm Name
    High Technology, Inc.
    Operator Number
    10035029
    Address
    20 Alice Agnew Dr.
    City
    Attleboro Falls
    State
    MA
    Postal Code
    02763
    Country
    US
    Correspondent
    Gary Titov

    Products

    Device Name Product Code
    Calibrator, Secondary JIT
    System, Test, Low Density, Lipoprotein MRR
    Tetraphenyl Borate, Colorimetry, Potassium CEJ
    Diazo Colorimetry, Bilirubin CIG
    Ldl & Vldl Precipitation, Hdl LBR
    Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase CFJ
    Centrifuge, Blood-Bank For In Vitro Diagnostic Use KSO
    Counter, Cell, Automated (Particle Counter) GKL
    Calibrator, Multi-Analyte Mixture JIX
    Biuret (Colorimetric), Total Protein CEK
    Whole Blood Hemoglobin Determination KHG
    Fibrin Split Products GHH
    Formulations, Balanced Salt Solutions KIP
    Kinetic Method, Gamma-Glutamyl Transpeptidase JQB
    Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use LXG
    Detergent JCB
    Glucose Oxidase, Glucose CGA
    Test, Time, Partial Thromboplastin GGW
    Acid, Lactic, Enzymatic Method KHP
    Bath, Incubators/Water, All JTQ
    Multi-Analyte Controls, All Kinds (Assayed) JJY
    Hexokinase, Glucose CFR
    Microscope, Inverted Stage, Tissue Culture IBL
    Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control DAP
    Automated Urinalysis System KQO
    Calibrator, Primary JIS
    Acid Phosphatase (Prostatic), Tartrate Inhibited JFH
    Uranyl Acetate/Zinc Acetate, Sodium CEI
    Light, Microscope IBJ
    Single (Specified) Analyte Controls (Assayed And Unassayed) JJX
    Activated Partial Thromboplastin GFO
    Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes CGS
    Urease And Glutamic Dehydrogenase, Urea Nitrogen CDQ
    Assay, Glycosylated Hemoglobin LCP
    Enzymatic Method, Creatinine JFY
    Plasma, Control, Normal GIZ
    Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes CJE
    Products, Red-Cell Lysing Products GGK
    Bromcresol Green Dye-Binding, Albumin CIX
    Mixture, Hematology Quality Control JPK
    Lipase-Esterase, Enzymatic, Photometric, Lipase CHI
    Nadh Oxidation/Nad Reduction, Alt/Sgpt CKA
    Mercuric Thiocyanate, Colorimetry, Chloride CHJ
    Phosphomolybdate (Colorimetric), Inorganic Phosphorus CEO
    Albumin, Fitc, Antigen, Antiserum, Control DDZ
    Saccharogenic, Amylase CIJ
    Photometric Method, Magnesium JGJ
    General Purpose Reagent PPM
    Cresolphthalein Complexone, Calcium CIC
    Ferrozine (Colorimetric) Iron Binding Capacity JMO
    Analyzer, Chemistry (Photometric, Discrete), For Clinical Use JJE
    Acid, Uric, Uricase (Colorimetric) KNK
    Enzymatic Esterase--Oxidase, Cholesterol CHH
    Indicator Method, Protein Or Albumin (Urinary, Non-Quant.) JIR
    Enzymatic Method, Ammonia JIF
    Nadh Oxidation/Nad Reduction, Ast/Sgot CIT
    Fibrometer GIE
    Diluent, Blood Cell GIF
    Enzymatic, Carbon-Dioxide KHS
    Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method DIC
    Electrode, Ion Selective (Non-Specified) JJP
    Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides CDT
    Test, Time, Prothrombin GJS
    Colorimeter, Photometer, Spectrophotometer For Clinical Use JJQ

    Proprietary Names

    Microalbumin Standard Set Microalbumin Calibrator Set Low-density lipoprotein (LDL) Reagent Set Potassium Reagent Set Bilirubin Direct (semi-auto) Reagent Set Bilirubin Total (semi-auto) Reagent Set Bilirubin Direct (auto) Reagent Set Bilirubin Total (auto) Reagent Set High-density lipoprotein (HDL) Reagent Set Lactate dehydrogenase (LDH-L) Reagent Set Power Spin MX Power Spin FX Power Spin BX Power Spin LX HTI PowerSpin HX Centrifuge HTI PowerSpin Series Centrifuge HTI PowerSpin VX Centrifuge HTI PowerSpin MX Centrifuge HTI PowerSpin FX Centrifuge HTI PowerSpin LX Centrifuge MicroCC-20 Plus MicroCC-20 Vet MicroCC-25 Plus Chemistry Multi-Calibrator Set Total Protein Reagent Set Microprotein Reagent Set Hemoglobin Reagent Set HT-Coag D-Dimer Reagent Kit HTI Sheath Focusing Solution Gamma-glutamyl transferase (GGT) Reagent Set HTI SA-18 HTI Detergent HTI Detergent Drypack Glucose Oxidase Reagent Set HT-Coag PT Reagent kit Lactate Reagent Set HTI ImmunoChem-2600 HTI ImmunoChem-2600 Plus HTI ImmunoChem-2200 HTI ImmunoChem-2200 Plus ImmunoChem 2600 ImmunoChem 2200 Chemistry Control Set Microalbumin Control Set Creatine Kinase-MB Control Set Ammonia/Alcohol Control Set Linearity Control Material HTI Urine Control Kit HTI Control kit HTI BioChem-Check Kit Glucose Hexokinase Reagent Set HTI IV-Series Microscope HT-Coag Fibrinogen Reference Plasma Reagent kit HT-Coag Fibrinogen Assay kit HT-Coag Thrombin Reagent kit (for Fib Assay) HT-Coag D-Dimer Calibrator HTI CL-50 Plus Urine Analyzer CL-500 CL-50 Plus HTI CL-50 Urine Analyzer HTI Urine Analyzer HTI CL-500 Urine Analyzer Direct HDL/LDL Control Set Lipid Control Set Acid Phosphatase Reagent Set Sodium (auto) Reagent Set Sodium (semi-auto) Reagent Set HTI H-Series Microscope HTI IP-Series Microscope HTI M-Series Microscope HTI G-Series Microscope HTI Z-Series Microscope Fructosamine Control Set Precision Test Fluid P150 & P250 HT-Coag APTT Reagent kit Creatine Kinase-MB Reagent Set Creatine Kinase (CK) Reagent Set Urea Nitrogen (BUN) Reagent Set Glycohemoglobin Control Set Fructosamine Reagent Set Glycohemoglobin Reagent Set Hemoglobin A1c Control Set Glycosylated hemoglobin (HbA1c) Reagent Set Hemoglobin A1c (HbA1c) Control Set Hemoglobin A1c (HbA1c) Standard Set Hemoglobin A1c (HbA1c) Reagent Set Hemoglobin A1c (HbA1c) Calibrator Set Creatinine Reagent Set HT-Coag Control 3 Reagent kit HT-Coag Calibration Plasma Reagent kit HT-Coag Control 2 Reagent kit HT-Coag Multicalibrator Reagent kit HT-Coag Control 1 Reagent kit HT-Coag D-Dimer Control Alkaline Phosphatase Reagent Set HTI Lytic Reagent Albumin Reagent Set Hemoglobin Control Set Lipase Reagent Set ALT, Alanine aminotransferase (GPT), Reagent Set Alanine Aminotransferase (ALT or SGPT) Reagent Set Chloride Reagent Set Phosphorus Reagent Set Microalbumin Reagent Set Amylase Reagent Set Magnesium Reagent Set HTI Enzymatic Cleaner HTI Cleaning Solution Washing Solution (Activation) Washing Solution (De-proteinizer) Refill Solution for ISE Electrodes Reagent Pack (Calibrant A, Calibrant B) HTI Enzymatic Cleaner Concentrate Refill Solution for Reference Electrode Washing Solution (Cleaning) Washing Solution Cleaning Solution HTI Enzymatic Cleaner Drypack Shutdown Pack HT-Coag Calcium Chloride Reagent Kit HT-Coag Imidazole Buffered Saline Reagent Kit Urine Dilute Solution Calcium Arsenazo Reagent Set Calcium Reagent Set Iron (semi-auto) Reagent Set Iron (auto) Reagent Set Direct Total Iron-Binding Capacity (TIBC) Reagent Set Total Iron-Binding Capacity (TIBC) Reagent Set BioChem FC-200 BioChem FC-360 BioChem FC-120 E-Lyte Plus BioChem SA BioChem FC-200Plus Uric Acid Reagent Set Cholesterol Reagent Set UrineRS H11 UrineRS E10 UrineRS A10 UrineRS H10 UrineRS H13 Calibration Strips UrineRS H14 Ammonia Reagent Set AST, Aspartate aminotransferase (GOT), Reagent Set TS Pro TS Auto TS 4000 Plus HTI Hematology Diluent HTI Diluent Drypack CO2 Reagent Set Alcohol Reagent Set Electrode, pH Electrode, Potassium (K) Electrode, Calcium (Ca) Electrode, Reference Electrode, Chloride (Cl) Electrode, Blank Electrode, Lithium (Li) Electrode, Sodium (Na) Electrode, Magnesium (Mg) Triglycerides Reagent Set HT-Coag Thrombin Time Reagent kit HTI ImmunoChem-2100 Immunochem-2100

    Establishment Types

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