BEUDAMED
    FDA Registration Active 🇺🇸 United States

    ELITechGroup Inc

    Reg #: 1717966 · FEI: 1717966 · Expires 2026
    View on FDA
    Products
    26
    Proprietary Names
    211
    Establishment Types
    5
    Classifications
    26

    Registration Details

    Registration Name
    ELITechGroup Inc
    Registration Number
    1717966
    FEI Number
    1717966
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    370 West 1700 South
    City
    LOGAN
    State
    UT
    ZIP
    84321
    Country
    US

    Regulatory Submissions

    510(k) Number
    K031539

    Owner / Operator

    Firm Name
    ELITechGroup Inc.
    Operator Number
    1717966
    Address
    370 West 1700 South
    City
    Logan
    State
    UT
    Postal Code
    84321
    Country
    US

    Products

    Device Name Product Code
    Comparison Of Freezing Points & Stds. Of Known Osmotic Pressure, Osmolality JMZ
    Assay, Glycosylated Hemoglobin LCP
    Osmometer For Clinical Use JJM
    Device, Iontophoresis, Specific Uses KTB
    Quality Control Slides LJG
    Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use LXG
    Electrode, Ion-Specific, Chloride CGZ
    Slide Stainer, Automated KPA
    Multi-Analyte Controls, All Kinds (Assayed) JJY
    Single (Specified) Analyte Controls (Assayed And Unassayed) JJX
    Stains, Microbiologic JTS
    Calibrator, Primary JIS
    Enzymatic, Carbon-Dioxide KHS
    Calibrator, Multi-Analyte Mixture JIX
    Coulometric, Chloride JFS
    Enzymatic Esterase--Oxidase, Cholesterol CHH
    Electrode, Ion Specific, Sodium JGS
    Analyzer, Chemistry (Photometric, Discrete), For Clinical Use JJE
    Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph CHL
    Electrode, Ion Specific, Potassium CEM
    General Purpose Reagent PPM
    Device, Automated Sedimentation Rate GKB
    Cytocentrifuge IFB
    Electrode, Ion Selective (Non-Specified) JJP
    Vapor Pressure, Osmolality Of Serum & Urine JNA
    Nadh Oxidation/Nad Reduction, Ast/Sgot CIT

    Proprietary Names

    Optimole Osmolality Standard, 1000 mmol/kg Optimole Osmolality Standard, 100 mmol/kg Optimole Osmolality Standard, 290 mmol/kg Direct A1c Reagent Set Direct A1c Control Kit Direct A1c Calibrator Kit FreezePoint® Freezing Point Osmometer, Model 6000 FreezePoint® Freezing Point Osmometer, Model 6000S FreezePoint® Freezing Point Osmometer, Model 6000P FreezePoint® Freezing Point Osmometer, Model 6000SP Macroduct® Advanced Supply Kit, Qty 6 Macroduct® Advanced 3710 Sweat Collection System Macroduct® Advanced Supply Kit, w/o Dye, Qty 6 Macroduct® Advanced Strap Set Macroduct® Advanced Electrode Cable Assembly Macroduct® Advanced Strap Set, 180 ea Gram Stain Control Slides AFB/TB Stain Control Slides Cytopro® Dual Microscope Slides, Uncoated, Qty 72 Cytopro® Single Microscope Slides, Uncoated, Qty 72 Cytopro® Magnum Microscope Slides, Uncoated, Qty 72 Cytopro® Single Microscope Slides, Coated, Qty 72 Cytopro® Dual Microscope Slides, Coated, Qty 72 Cytopro® Magnum Microscope Slides, Coated, Qty 72 Sweat-Chek™ Sweat Conductivity Analyzer, Model 3120 Take-Up Tubes, 14 inch Aerospray® TB Slide Stainer/Cytocentrifuge, Model 7722 Aerospray® Hematology Pro Slide Stainer/Cytocentrifuge, Model 7152 Aerospray® Hematology Stat Slide Stainer/Cytocentrifuge, Model 7122 Aerospray® Gram Slide Stainer/Cytocentrifuge, Model 7322 Previ Color Gram V2 Previ Color Gram Aerospray® 12-Slide Carousel Aerospray® Cytology Slide Stainer/Cytocentrifuge, Model 7522 Aerospray® 30-Slide Carousel Aerospray® Cytology 12-Slide Carousel Aerospray® Cytology Stain F Empty Bottle w/Level Detect Aerospray® Cytology 30-Slide Carousel OSMOCOLL® HNL Osmolality Controls, 6x1mL Accu-Sed® Plus Normal / Abnormal ESR Control, 4x8.5 mL Accu-Sed® Plus Normal / Abnormal ESR Control Set, 10x8.5mL Sweat Controls, L1, L2, L3, 12 ea., 36x0.75mL Accu-Sed® Plus Normal ESR Control, 5x8.5mL Accu-Sed® Plus Abnormal ESR Control, 5x8.5mL Accu-Sed® Plus Normal / Abnormal ESR Control, 2x8.5mL M800751 - MGB Alert Adenovirus Positive Control DNA Template M800752 - MGB Alert CMV Positive Control DNA Template M800750 - MGB Alert BK Virus Positive Control DNA Template M800748 - MGB Alert® EBV Positive Control DNA Template M800749 - MGB Alert HHV-6 Positive Control DNA Template Aerospray® Hematology Stat Reagent A, Rinse Concentrate, 135mL Aerospray® Cytology Stain C, Bluing Agent, 500mL Aerospray® TB Reagent A, Carbol Fuchsin Decolorizer Concentrate, 30mL Aerospray® Gram Reagent A, Decolorizer with Safranine, 500mL Aerospray® Hematology Reagent D, Aerofix® Fixative Concentrate, 135mL Aerospray® TB Reagent C, Auramine/Rhodamine (mod), 500mL Previ® Color Gram Fuchsin Solution Aerospray® TB Reagent B, Brilliant Green, 500mL Aerospray® Gram Reagent A, Decolorizer with Fuchsin, 500mL Aerospray® TB Reagent A, Carbol Fuchsin Decolorizer, 500mL Aerospray® TB Reagent C, Auramine O, 500mL Previ® Color Gram Acetone Fuchsin Solution Aerospray® TB Reagent B, Potassium Permanganate Concentrate, 200mL Aerospray® TB Reagent B, Methylene Blue, 500mL Aerospray® Hematology Stat Surfactant, 14mL Aerospray® Nozzle Cleaning Solution, 355mL Aerospray® Hematology Stat Reagent C, Eosin Stain, 500mL Aerospray® Hematology Pro Reagent B, Thiazin Stain, 500mL Aerospray® Gram Reagent A, Safranine Concentrate, 210mL Aerospray® Hematology Stat Reagent B, Thiazin Stain, 500mL Aerospray® Reagent Grade Methanol, 500mL Aerospray® Stain Residue Solvent, 500mL Aerospray® Hematology Reagent D, Aerofix® Fixative, 500mL Aerospray® Hematology Pro Reagent A, Buffer (pH 7.2), 1Gal Aerospray® Gram Reagent B, Iodine Concentrate, 500mL Aerospray® Hematology Stat Reagent A, Rinse, 500mL Aerospray® Gram Reagent A, Decolorizer with Acetone and Fuchsin, 500mL Aerospray® Cytology Stain F, Acid Alcohol, 500mL Aerospray® Cytology Stain D, Hematoxylin I, 500mL Aerospray® TB Reagent A, Fluorescence Decolorizer Concentrate, 30mL Aerospray® TB Reagent B, Potassium Permanganate, 500mL Previ® Color Gram Safranin Solution Aerospray® Hematology Stat Reagent C, Eosin Stain, 1Gal Aerospray® Hematology Pro Reagent C, Eosin Stain, 500mL Aerospray® Gram Reagent A, Fuchsin Concentrate, 135mL Aerospray® Cytology Stain D, Hematoxylin II, 500mL Aerospray® TB Reagent B, Brilliant Green Concentrate, 130mL Aerospray® Hematology Stat, Basofix™ Pre-dip Fixative, 500mL Aerospray® Cytology Stain B, Orange G Stain, 500mL Aerospray® TB, Mycohold™ Cell Adhesive, 500mL Aerospray® Gram Reagent B, Iodine, 500mL Aerospray® TB Reagent A, Fluorescence Decolorizer, 500mL Aerospray® Hematology Stat Reagent C, Basofix™ Eosin Stain, 500mL Aerospray® Cytology Stain A, EA-50 Stain, 500mL Aerospray® TB Reagent B, Methylene Blue Concentrate, 130mL Aerospray® Nozzle Cleaning Solution Concentrate, 250mL Aerospray® Hematology Stat Reagent A, Basofix™ Rinse, 500mL Aerospray® Gram Reagent C, Crystal Violet Concentrate, 135mL Aerospray® Hematology Pro Reagent C, Eosin Stain Concentrate, 220mL Aerospray® Gram Reagent A, Decolorizer with Acetone and Safranine, 500mL Aerospray® Cytology Stain E, Acid Wash, 500mL Aerospray® Hematology Stat Reagent C, Eosin Stain Concentrate, 135mL Previ® Color Gram Crystal Violet Solution Aerospray® Hematology Stat Reagent B, Thiazin Stain, 1Gal Aerospray® Hematology Pro Reagent A, Buffer (pH 6.8), 1Gal Aerospray® Gram Reagent C, Crystal Violet, 500mL Aerospray® PM Cleaning Solution, 500mL Aerospray® Hematology Pro Reagent A, Buffer (pH 6.8) Concentrate, 30mL Previ® Color Gram Acetone Safranin Solution Aerospray® Hematology Stat Reagent A, Rinse, 1Gal Aerospray® Hematology Stat, Basofix™ Pre-dip Fixative Concentrate, 15mL Aerospray® Hematology Pro Reagent B, Thiazin Stain Concentrate, 200mL Aerospray® Hematology Stat Reagent B, Thiazin Stain Concentrate, 135mL Aerospray® TB Reagent C, ELITe ZN, 500mL Previ® Color Gram Iodine Solution Aerospray® Hematology Pro Reagent A, Buffer (pH 7.2) Concentrate, 30mL Aerospray® Line Cleaner, 250mL Aerospray® TB, Mycohold™ Cell Adhesive Concentrate, 100mL Aerofix® for Aerospray® Gram and TB Stainers Aerospray® TB Reagent B, Thiazin Red, 500mL Aerospray® TB Reagent B, Carbol Solution, 500mL Sweat-Chek™ Calibrator, 90 mmol/L, 60x0.75mL Carbon Dioxide Electrode, REF 3918-003 ChloroChek® Chloridometer® Sweat Chloride Analyzer, Model 3400 ChloroChek® Reagent Set, 37x10mL BS + 1x30mL GS Sweat Controls, L1, L2, L3 12 ea., 36x0.75mL ChloroChek® Standard Solution, 100 mmol/L, 10x1mL Sodium Electrode, REF 278-001 Potassium Electrode, REF 279-001 Carbon Dioxide Electrode, 275-001 Chloride Electrode, REF 280-001 MGB Alert® 2X Hot Start Master Mix MGB Alert® PCR Master Mix MGB Alert® Positive Controls MGB Alert® Platinum Master Mix MGB Alert 2X PCR Master Mix (MGB Alert 2X Hot Start Master Mix/Tfi) MGB Alert One-Step Reverse Transcriptase PCR Master Mix Acid Solution System Solution SYSTEM SOLUTION For Viva Drug Testing Systems System Cleaning Solution Envoy Rinse Solution Envoy 500 Wash Solution Kit Envoy Rinse Solution Bulk Kit MGB Alert ELITaq Master Mix 480-rxn - M800810 MGB Alert ELITaq Master Mix 48-rxn - M800809 Envoy ISE Conditioner Envoy Rinse Solution Kit Excyte Mini ESR Analzyer Excyte 20 ESR Analyzer Excyte® ESR Vacuum Tube, EP-10605 Excyte® ESR Vacuum Tube, EP-10605-H1 Excyte® ESR Non-Vacuum Tubes, EX-50100 Microsed-System® Automated ESR Analyzer Monosed® ESR Vacuum Tubes, PRD-PRV11V-H12 Monosed® ESR Vacuum Tubes, PRD-PRV11B-50 Excyte® ESR Vacuum Tubes, EX-50205 Mix-Rate® X20 Automated ESR Analyzer Excyte Mini ESR Analzyer, 8mm Excyte 20 ESR Analyzer, 9mm Cytopro® Cytocentrifuge, Model 7622 Cytopad®, Dual Fast (White), Qty 100 Cytopro® Single Sample Chambers, w/ Fast (White) Cytopad®, Qty 48 Cytopro® Single Sample Chamber Caps, Qty 48 Cytopro® Dual Sample Chamber Caps, Qty 48 Cytopad®, Single, Fast (White), Qty 100 Cytopro® Rotor Cytopad®, Single, Slow (Tan), Qty 100 Cytopro® Dual Chambers & Cytopad® Slow (Tan), Qty 48 Cytopro® Dual Chambers & Cytopad® Slow (Tan), & Caps, Qty 48 Cytopro® Dual Chambers & Cytopad® Fast (White), & Caps, Qty 48 Cytopro® Dual Chambers & Cytopad® Fast (White), Qty 48 Cytopro® Single Sample Chambers, w/ Slow (Tan) Cytopad®, Qty 48 Cytopro® Single Chambers & Cytopad® Fast (White), & Caps, Qty 48 Cytopad®, Dual Slow (Tan), Qty 100 Cytopro® Single Chambers & Cytopad® Slow (Tan), & Caps, Qty 48 Previ Color Cytocentrifuge Envoy Reference Electrode Envoy Bypass Electrode Nanoduct® Neonatal Sweat Analysis System, Model 1030 Nanoduct® Neg (-) Black Holder Nanoduct® Electrode Strap Nanoduct® Electrode Cable Set Assembly Nanoduct® Attachment Strap Retainer Post Nanoduct® Calibration Standard Plate Nanoduct® Pos (+) Red Holder Nanoduct® Supply Kit, Qty 6 Nanoduct® Conductivity Sensor Cell, Qty 1 Nanoduct® Electrode Strap, large qty 1 Nanoduct® Electrode Strap, medium qty 1 FreezePoint® Calibration Standard, 300 mOsmol/kg, 10x0.8mL FreezePoint® Calibration Standard, 850 mOsmol/kg, 10x0.8mL Macroduct® Sweat Collection System, Model 3700-SYS Macroduct® Supply Kit, w/o Dye, Qty 6 Macroduct® Red Electrode Strap, Qty 1 Macroduct® Black Electrode Strap, Qty 1 Macroduct® Collection Strap Macroduct® Supply Kit, Qty 6 Macroduct® Electrode Cable Assembly Macroduct Strap, Large (diam up to 9 cm) Macroduct Strap, X-Large (diam up to 13 cm) Macroduct Strap Set (1 ea: S, M, L, XL) Macroduct Strap, Medium (diam up to 6 cm) Macroduct Collector - No Dye Macroduct Pilogel Discs, Vial of 12 Macroduct Collector VAPRO® Vapor Pressure Osmometer, Model 5600 VAPRO® Vapor Pressure Osmometer Extended Range, Model 5600XR Potassium Electrode, REF 3918-005 Chloride Electrode, REF 3918-006 Sodium Electrode, REF 3918-004

    Establishment Types

    Manufacture Medical Device Complaint File Establishment per 21 CFR 820.198 Repack or Relabel Medical Device Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device for Another Party (Contract Manufacturer)