Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1717966

FEI Number

1717966

Entity Name

ELITechGroup Inc

City/State/Country

LOGAN, UT, US

Establishment Address

370 West 1700 South, LOGAN, UT 84321, US

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility,Manufacture Medical Device

Owner / Operator

ELITechGroup Inc. (Owner Number: 1717966)

Owner / Operator Contact Address

370 West 1700 South, Logan, UT 84321, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered 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

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
JMZ	Comparison Of Freezing Points & Stds. Of Known Osmotic Pressure, Osmolality	Clinical Chemistry	Class 1	862.1540	2023-08-09
LCP	Assay, Glycosylated Hemoglobin	Hematology	Class 2	864.7470	2020-12-31
JJM	Osmometer For Clinical Use	Clinical Chemistry	Class 1	862.2730	2020-05-29
KTB	Device, Iontophoresis, Specific Uses	Physical Medicine	Class 2	890.5525	2018-08-06
LJG	Quality Control Slides	Microbiology	Class 1	866.2660	2020-12-31
LXG	Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use	Clinical Chemistry	Class 1	862.2050	2020-12-31
CGZ	Electrode, Ion-Specific, Chloride	Clinical Chemistry	Class 2	862.1170	2007-12-06
KPA	Slide Stainer, Automated	Pathology	Class 1	864.3800	2001-11-27
JJY	Multi-Analyte Controls, All Kinds (Assayed)	Clinical Chemistry	Class 1	862.1660	2019-12-26
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2020-12-31
JTS	Stains, Microbiologic	Hematology	Class 1	864.1850	2011-04-14
JIS	Calibrator, Primary	Clinical Chemistry	Class 2	862.1150	2019-12-26
KHS	Enzymatic, Carbon-Dioxide	Clinical Chemistry	Class 2	862.1160	2013-11-07
JIX	Calibrator, Multi-Analyte Mixture	Clinical Chemistry	Class 2	862.1150	2013-11-07
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2013-10-23
JFS	Coulometric, Chloride	Clinical Chemistry	Class 2	862.1170	2013-10-23
CGZ	Electrode, Ion-Specific, Chloride	Clinical Chemistry	Class 2	862.1170	2013-12-05
CHH	Enzymatic Esterase--Oxidase, Cholesterol	Clinical Chemistry	Class 1	862.1175	2013-12-05
JGS	Electrode, Ion Specific, Sodium	Clinical Chemistry	Class 2	862.1665	2013-12-05
JJE	Analyzer, Chemistry (Photometric, Discrete), For Clinical Use	Clinical Chemistry	Class 1	862.2160	2013-12-05
CHL	Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph	Clinical Chemistry	Class 2	862.1120	2013-12-05
CEM	Electrode, Ion Specific, Potassium	Clinical Chemistry	Class 2	862.1600	2013-12-05
PPM	General Purpose Reagent	Pathology	Class 1	864.4010	2009-10-12
GKB	Device, Automated Sedimentation Rate	Hematology	Class 1	864.5800	2014-12-04

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

ELITechGroup Inc.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3044320359	ELITechGroup Inc., Tucson	Tucson, AZ, US
3011461582	ELITechGroup S.p.A.	Torino Piedmont, IT
3003540236	ELITechGroup MDX LLC.	Bothell, WA, US
3006091463	ELITechGroup MICROBIO	SIGNES Var, FR

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K920820	Helena Laboratories	MODIFICATION COLUMNMATE	1992-08-17
K991850	Biosafe Laboratories, Inc.	SAFE AT-HOME TEST KIT FOR MONITORING HEMOGLOBIN ALC	1999-11-26
K990531	Ortho-Clinical Diagnostics, Inc.	VITROS IMMUNODIAGNOSTIC PRODUCTS ONCOLOGY CONTROLS	1999-03-12
K982637	Diagnostic Products Corp.	IMMULITE PSA CONTROL MODULE, MODEL LPSCM	1998-08-12
K012468	Dade Behring, Inc.	MODIFICATION TO N/T PROTEIN CONTROL SL	2001-09-04

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0017-2012	Bio-Rad Laboratories, Inc.	2	D-10 Hemoglobin A1c Program Reorder Pack; 400 tests; For the determination of Hemoglobin A1c in human whole blood. IVD Contents: 1. Elution Buffer 1 2 x 2000 ml Bio-Tris Phosphate Buffer 2. Elution Buffer 2 1 x 1000 ml Bio-Tris Phosphate Buffer 3. Wash/Diluent 1 x 1600 mL Deionized water 4. Analytical cartridge - 1 cation exchange cartridge 5. Floppy Diskette 1-program parameters 6. Calibrator/Diluent set. 2 levels of calibrator, 3 vial each: lyophylized human blood cell hemolysate with preservative; 1 bottle 100 mL or diluent deionized water. 7. Whole Blood Primer: 4 vials Lyophylized human red blood cells hemolysate with preservative. 8. Sample vials, 100 x 1.5 mL Polypropylene with pierceable lid 9 Thermal paper - 1 roll 10. Instruction manual Made in United States Bio-Rad Laboratories, Hercules, CA 94547. Percentage determination of hemoglobin A1c in human whole blood using ion-exchange high=performance liquid chromatography (HPLC)
Z-0018-2012	Bio-Rad Laboratories, Inc.	2	D-10 Hemoglobin A1c Supplemental Reagent Pack: Bio-Rad Laboratories, Hercules, CA 94547. Percentage determination of hemoglobin A1c in human whole blood using ion-exchange high=performance liquid chromatography (HPLC)
Z-0019-2012	Bio-Rad Laboratories, Inc.	2	D-10 Hemoglobin A1c Program Elution Buffer 2: Bio-Rad Laboratories, Hercules, CA 94547. Percentage determination of hemoglobin A1c in human whole blood using ion-exchange high=performance liquid chromatography (HPLC)
Z-0020-2012	Bio-Rad Laboratories, Inc.	2	VARIANT II TURBO Hemoglobin A1c Program Reorder Pack, 1600 tests, IVD, Made in United States. Kit contains: 1. Elution Buffer A 3 x 2500 mL, Bis-Tris Phosphate Buffer 2. Elution Buffer B 1 x 1500 mL Bis-Tris Phosphate Buffer 3. Cartridge Set, 2 cation exchange analytical cartridges, 4 cation exchange Guard cartridges. 4. CD-ROM 1 - CD Rom with program parameters 5. Calibration/Diluent set - 2 levels, 2 vial each of lyophilized human red blood cell hemolysate with preservative, 1 bottle diluent, 100 mL deionized water. 6. Whole Blood Primer, 6 x 1 mL, lyophilized human red blood cell hemolysate with preservative, 7. Sample vials - 2 x 100, 1.5 mL polypropylene vials with pierceable caps. 8. Instruction Manual. Bio-Rad Laboratories, Hercules, CA 94547. Percentage determination of hemoglobin A1c in human whole blood using ion-exchange high=performance liquid chromatography (HPLC)
Z-0021-2012	Bio-Rad Laboratories, Inc.	2	VARIANT II TURBO Hemoglobin A1c Program Reorder Pack, 2000 tests, IVD, Made in United States. Kit contains: 1. Elution Buffer A 3 x 2500 mL, Bis-Tris Phosphate Buffer 2. Elution Buffer B 1 x 1500 mL Bis-Tris Phosphate Buffer 3. Cartridge Set, 2 cation exchange analytical cartridges, 5 cation exchange Guard cartridges. 4. CD-ROM 1 - CD Rom with program parameters 5. Calibration/Diluent set - 2 levels, 3 vials each of lyophilized human red blood cell hemolysate with preservative, 1 bottle diluent, 100 mL deionized water. 6. Whole Blood Primer, 6 x 1 mL, lyophilized human red blood cell hemolysate with preservative, 7. Sample vials - 2 x 100, 1.5 mL polypropylene vials with pierceable caps. 8. Instruction Manual. Bio-Rad Laboratories, Hercules, CA 94547. Percentage determination of hemoglobin A1c in human whole blood using ion-exchange high=performance liquid chromatography (HPLC)

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1717966. Last updated year: 2026. Please use registration number 1717966 when referencing this establishment in official correspondence.