ELITECH

FDA Registration(s)#

Registration, FEI, Name table
Registration	FEI	Name	Status	Initial importer	Expiration year	Address
1717966	1717966	ELITechGroup Inc	1	Y	2026-01-01	370 West 1700 South LOGAN UT US 84321
3003540236	3003540236	ELITechGroup MDX LLC.	1	Y	2026-01-01	21720 23rd Dr SE, Suite 150 Bothell WA US 98021
3044320359	3044320359	ELITechGroup Inc., Tucson	1	N	2026-01-01	3950 S. Country Club Rd. Suite #470, L Tucson AZ US 85714

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDID	Product	Phone	Email
03661540304156	Potassium Electrode - ISE electrode for the measurement of Potassium in IVD samples.	(800) 453 2725	service.ebs@elitechgroup.com
03661540304163	Chloride Electrode - ISE electrode for the measurement of Chloride in IVD samples.	(800) 453 2725	service.ebs@elitechgroup.com

elitechgroup.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration key	Listing key	Premarket submission	Device	Product code	Decision date
32802	1165302587	K863395	WESCOR SWEAT.CHEK SWEAT CONDUCTIVITY ANALYZER	CGZ	1988-05-24
32802	2065332837	K853973	WESCOR MODEL 3700 WEBSTER SWEAT INDUCER	KTB	1985-10-16
349362	1313462725	K240854	Accelerate Arc System	QNJ	2024-09-26
32802	2043695790	K180627	Macroduct Advanced Model 3710	KTB	2018-07-27
108982	1764419289	K180559	HSV 1 & 2 ELITe MGB Kit; ELITe InGenius	PGI	2018-10-29
108982	1536595845	K132468	MRSA/SA ELITE MGB, ELITE MGB SOFTWARE	NQX	2013-10-17
32802	1345106223	K121823	CLINICAL CHLORIDE ANALYZER, CHLORIDE TEST SYSTEM, SWEAT CHLORIDE ANALYZER, CHLORIDOMETER, CHLORIDE COULOMETRIC	JFS	2013-03-27
108982	1175636932	K112937	MRSA/SA ELITE MGB	NQX	2012-06-01
108982	1397365503	K083430	REAL-TIME PCR INTERNAL CONTROL 2B SET	OLD	2009-01-15
32802	1202784444	K032608	GONOTEC CALIBRATION SOLUTION 300 MOSMOL/KG FOR OSMOMETER	JIS	2003-10-21
32802	1205576649	K031539	HEMOGLOBIN A1C REAGENT SET	LCP	2003-08-06
32802	1711617286	K010031	NANODUCT NEONATAL SWEAT ANALYSIS SYSTEM	KTB	2001-03-20
32802	1070327260
32802	1926202927
108982	2031134576
32802	1105972696
32802	1118086861
32802	1127690770
32802	1143812424
32802	1230867168
32802	1234347663
32802	1235547482
32802	1275132654
32802	1363330821
32802	1373199278
32802	1422949660
32802	1617128577
108982	1743020633
32802	1847821436
32802	1898370667
108982	1915549129
32802	1936648840
108982	1946864853
32802	2031134576
32802	2041971128

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product code	Registration listing records	Latest decision
KTB	3	2018-07-27
NQX	2	2013-10-17
QNJ	1	2024-09-26
PGI	1	2018-10-29
JFS	1	2013-03-27
OLD	1	2009-01-15
JIS	1	2003-10-21
LCP	1	2003-08-06
CGZ	1	1988-05-24

PMN#

HSV 1 & 2 ELITe MGB Kit; ELITe InGenius

2018-10-29

ELITechGroup

Macroduct Advanced Model 3710

2018-07-27

ELITechGroup Inc.

ELITech Clinical Systems BILIRUBIN TOTAL 4+1, ELITech Clinical Systems BILIRUBIN DIRECT 4+1

2017-07-11

ELITechGroup

ELITech Clinical Systems GLUCOSE HK SL, ELITech Clinical Systems ELICAL 2, ELITech Clinical Systems ELITROL I And ELITROL II

2016-09-07

ELITechGroup

ELITech Clinical Systems CALCIUM ARSENAZO

2015-07-22

ELITechGroup

ELITech Clinical Systems ELICAL 2, ELITech Clinical Systems ELITROL I, ELITech Clinical Systems ELITROL II

2015-07-08

ELITechGroup

ELITECH CLINICAL SYSTEMS ENVOY 500 CK REAGENT KIT

2014-07-18

ELITECHGROUP

ELITECH CLINICAL SYSTEMS CREATININE PAP SL, ELICAL 2, ELITROL I AND ELITROL II, URINE CONTROL BI-LEVEL

2014-01-03

ELITECH GROUP

MRSA/SA ELITE MGB, ELITE MGB SOFTWARE

2013-10-17

ELITechGroup Epoch Biosciences

ELITECH CLINICAL SYSTEMS ELICAL 2; ELITECH CLINICAL SYSTEMS ELITROL I, ELITECH CLINICAL SYSTEMS ELITROL II

2013-04-04

ELITECHGROUP

ELITECH CLINICAL SYSTEMS URINE TOTAL PROTEIN PLUS STANDARD 100 MG/DL, ELITECH CLINICAL SYSTEMS URINE CONTROL BI-LEVEL

2013-02-15

ELITECHGROUP

ELTECH CHINICAL SYSTEM AMYLASE SL ELITECH CLINICAL SYSTEMS ELICAL2 ELTECH CLINICAL SYSTEMS ELITROL I AND ELITROL II

2012-10-03

ELITECHGROUP

ELITECH CLINICAL SYSTEMS CK NAC SL

2012-08-22

ELITECHGROUP

MRSA/SA ELITE MGB

2012-06-01

ELITECH

ELITTECH CLINICAL SYSTEMS ALP IFCC SL

2011-12-29

ELITECHGROUP

ELITECH CLINICAL SYSTEMS CARBON DIOXIDE ELECTRODE, ELITECH CLINICAL SYSTEMS ISE CALIBRATORS

2011-11-18

ELITECHGROUP

ELITECH CLINICAL SYSTEMS BILIRUBIN TOTAL 4+1, ELITECH CLINICAL SYSTEMS ELICAL 2, ELITECH CLINICAL SYSTMES ELITROL I & II

2011-10-07

ELITECH GROUP

ELITECH CLINICAL SYSEMS ISE CONTROL 1 AND 2

2011-09-14

ELITECHGROUP

ELITECH CLINCAL SYSTEMS CHOLESTEROL HDL SL 2G, HDL 2G CALIBRATOR, LDL SL 2G, LDL 2G CALIBRATOR, ELITROL II & ELITECH SYS

2011-08-31

ELITECHGROUP SEPPIM S.A.S.

ELITECH CLINICAL SYSTEMS ELICAL 2, ELITECH CLINICAL SYSTEMS ELITROL I, ELITECH CLINICAL SYSTEMS ELITROL II MODEL CALI-05

2011-08-30

ELITECHGROUP

ELITECH CLINICAL SYSTEMS CALCIUM ARSENAZO; ELITECH CLINICAL SYSTEMS ALBUMIN; ELITECH CLINICAL SYSTEMS ELICAL 2; ELITECH

2011-06-21

ELITECHGROUP

ELITECH CLINICAL SYSTEMS SELECTRA PROM/ELICAL 2/ELITROL I AND ELITROL II/AST/GOT 4+1 SL/POTASSIUM, SODIUM, CHLORIDE...

2011-03-24

ELITECHGROUP VITAL SCIENTIFIC BV

GUDID#

Macroduct Advanced Sweat Collection System - The Macroduct Advanced Sweat Collection System is intended only for clinical laboratory use by qualified medical personnel for stimulation and collection of sweat from humans for analysis for the diagnosis of cystic fibrosis.

ELITECHGROUP INC.

2025-02-27

Sodium Electrode - ISE electrode for the measure of Sodium in IVD samples.

ELITECHGROUP INC.

2023-10-01

Carbon Dioxide Electrode - ISE electrode for the measure of CO2 in IVD samples.

ELITECHGROUP INC.

2023-10-01

Chloride Electrode - ISE electrode for the measurement of Chloride in IVD samples.

ELITECHGROUP INC.

2023-10-01

Potassium Electrode - ISE electrode for the measurement of Potassium in IVD samples.

ELITECHGROUP INC.

2023-10-01

Direct A1c Reagent Kit - For the quantitative determination of Hemoglobin A1c (HBA1c) in human blood.

ELITECHGROUP INC.

2023-10-01

Direct A1c Calibrator Kit - Calibrator intended to establish known points of reference for use with Direct A1c Reagent Kit 55370.

ELITECHGROUP INC.

2023-10-01

Direct A1c Control Kit - A material which is used to verify the performance of Direct A1c Reagent Kit 55370.

ELITECHGROUP INC.

2023-10-01

Excyte® ESR Vacuum Tube - ESR Tubes are single use devices intended to be used as whole blood sample tubes for the quantitative determination of Erythrocyte Sedimentation Rate (ESR) using ELITechGroup ESR analyzers. These devices are to be used by trained medical personnel only. The ESR tubes are intended for IN VITRO DIAGNOSTIC USE ONLY (IVD).

ELITECHGROUP INC.

2023-10-01

Excyte® ESR Vacuum Tube - ESR Tubes are single use devices intended to be used as whole blood sample tubes for the quantitative determination of Erythrocyte Sedimentation Rate (ESR) using ELITechGroup ESR analyzers. These devices are to be used by trained medical personnel only. The ESR tubes are intended for IN VITRO DIAGNOSTIC USE ONLY (IVD).

ELITECHGROUP INC.

2023-10-01

Excyte® ESR Vacuum Tubes - ESR Tubes are single use devices intended to be used as whole blood sample tubes for the quantitative determination of Erythrocyte Sedimentation Rate (ESR) using ELITechGroup ESR analyzers. These devices are to be used by trained medical personnel only. The ESR tubes are intended for IN VITRO DIAGNOSTIC USE ONLY (IVD).

ELITECHGROUP INC.

2023-10-01

Excyte® ESR Non-Vacuum Tubes - ESR Tubes are single use devices intended to be used as whole blood sample tubes for the quantitative determination of Erythrocyte Sedimentation Rate (ESR) using ELITechGroup ESR analyzers. These devices are to be used by trained medical personnel only. The ESR tubes are intended for IN VITRO DIAGNOSTIC USE ONLY (IVD).

ELITECHGROUP INC.

2023-10-01

Monosed® ESR Vacuum Tubes, Carton - ESR Tubes are single use devices intended to be used as whole blood sample tubes for the quantitative determination of Erythrocyte Sedimentation Rate (ESR) using ELITechGroup ESR analyzers. These devices are to be used by trained medical personnel only. The ESR tubes are intended for IN VITRO DIAGNOSTIC USE ONLY (IVD).

ELITECHGROUP INC.

2023-10-01

Monosed® ESR Vacuum Tubes - ESR Tubes are single use devices intended to be used as whole blood sample tubes for the quantitative determination of Erythrocyte Sedimentation Rate (ESR) using ELITechGroup ESR analyzers. These devices are to be used by trained medical personnel only. The ESR tubes are intended for IN VITRO DIAGNOSTIC USE ONLY (IVD).

ELITECHGROUP INC.

2023-10-01

Mix-Rate® X20 Automated ESR Analyzer - The ESR analyzer is an automated, microprocessor controlled, in vitro diagnostic device that is intended for the quantitative determination of erythrocyte sedimentation rate (ESR) in human whole blood samples by laboratory professionals. Elevated ESR results indicate degrees of inflammation or disease present in the human body.

ELITECHGROUP INC.

2023-10-01

Microsed-System® Automated ESR Analyzer - The ESR analyzer is an automated, microprocessor controlled, in vitro diagnostic device that is intended for the quantitative determination of erythrocyte sedimentation rate (ESR) in human whole blood samples by laboratory professionals. Elevated ESR results indicate degrees of inflammation or disease present in the human body.

ELITECHGROUP INC.

2023-10-01

Excyte® ESR Vacuum Tube, Carton - ESR Tubes are single use devices intended to be used as whole blood sample tubes for the quantitative determination of Erythrocyte Sedimentation Rate (ESR) using ELITechGroup ESR analyzers. These devices are to be used by trained medical personnel only. The ESR tubes are intended for IN VITRO DIAGNOSTIC USE ONLY (IVD).

ELITECHGROUP INC.

2023-10-01

Excyte® ESR Vacuum Tube, Carton - ESR Tubes are single use devices intended to be used as whole blood sample tubes for the quantitative determination of Erythrocyte Sedimentation Rate (ESR) using ELITechGroup ESR analyzers. These devices are to be used by trained medical personnel only. The ESR tubes are intended for IN VITRO DIAGNOSTIC USE ONLY (IVD).

ELITECHGROUP INC.

2023-10-01

Excyte® ESR Vacuum Tubes, Carton - ESR Tubes are single use devices intended to be used as whole blood sample tubes for the quantitative determination of Erythrocyte Sedimentation Rate (ESR) using ELITechGroup ESR analyzers. These devices are to be used by trained medical personnel only. The ESR tubes are intended for IN VITRO DIAGNOSTIC USE ONLY (IVD).

ELITECHGROUP INC.

2023-10-01

Excyte® ESR Non-Vacuum Tubes, Carton - ESR Tubes are single use devices intended to be used as whole blood sample tubes for the quantitative determination of Erythrocyte Sedimentation Rate (ESR) using ELITechGroup ESR analyzers. These devices are to be used by trained medical personnel only. The ESR tubes are intended for IN VITRO DIAGNOSTIC USE ONLY (IVD).

ELITECHGROUP INC.

2023-10-01

Monosed® ESR Vacuum Tubes, Carton - ESR Tubes are single use devices intended to be used as whole blood sample tubes for the quantitative determination of Erythrocyte Sedimentation Rate (ESR) using ELITechGroup ESR analyzers. These devices are to be used by trained medical personnel only. The ESR tubes are intended for IN VITRO DIAGNOSTIC USE ONLY (IVD).

ELITECHGROUP INC.

2023-10-01

Monosed® ESR Vacuum Tubes, Carton - ESR Tubes are single use devices intended to be used as whole blood sample tubes for the quantitative determination of Erythrocyte Sedimentation Rate (ESR) using ELITechGroup ESR analyzers. These devices are to be used by trained medical personnel only. The ESR tubes are intended for IN VITRO DIAGNOSTIC USE ONLY (IVD).

ELITECHGROUP INC.

2023-10-01

Excyte - Multifunctional mixer for biological liquids

ELITECHGROUP INC.

2018-12-26

Microscope Slides, 1/2G, uncoated, Cytopro Dual - Microscope Slides, 1/2G, uncoated, Cytopro Dual. Slides are used to collect the material centrifuged out of the solutions contained in the sample chambers. Slides are designed specifically for single, double, or magnum chambers and come in coated and uncoated versions for each.

ELITECHGROUP INC.

2023-08-14

Aerospray® Cytology 30-Slide Carousel - For use with the Aerospray Cytology Slide Stainer/Cytocentrifuge

ELITECHGROUP INC.

2023-09-20

Aerospray® Cytology 12-Slide Carousel - For use with the Aerospray Cytology Slide Stainer/Cytocentrifuge.

ELITECHGROUP INC.

2023-09-20

Stain F Empty Bottle with Level Detect, Cytology Stainer - AC-197

ELITECHGROUP INC.

2023-08-17

Gram Stain Control Slides, Qty 50 - Colored slides to be used with Aerospray® Gram slide stainer/cytocentrifuges to aid in identifying cells.

ELITECHGROUP INC.

2023-08-15

Acid Fast Control Slide (pack of 50 slides) - Colored slides to be used with Aerospray® TB slide stainer/cytocentrifuges to aid in identifying cells.

ELITECHGROUP INC.

2023-08-15

Acid Fast Control Slide (pack of 10 slides) - Colored slides to be used with Aerospray® TB slide stainer/cytocentrifuges to aid in identifying cells.

ELITECHGROUP INC.

2023-08-15

Gram Control Slides - Colored slides to be used with Aerospray® Gram slide stainer/cytocentrifuges to aid in identifying cells. Qty. 10

ELITECHGROUP INC.

2023-08-15

Cytopro Magnum Sample Chambers w/ caps - SS-234

ELITECHGROUP INC.

2023-08-14

Dual Sample Chambers w/ slow, tan Cytopads, pk/48 - SS-216

ELITECHGROUP INC.

2023-08-14

Dual Sample Chambers w/ fast,white Cytopads, pk48 - SS-215

ELITECHGROUP INC.

2023-08-14

Dual Sample Chambers w/ slow,tan pads,caps,pk/48 - SS-214

ELITECHGROUP INC.

2023-08-14

Dual Sample Chambers w/ fast,white pads,caps,48 - SS-213

ELITECHGROUP INC.

2023-08-14

Cytopro Dual Cytopad, slow, tan, pack of 100 - SS-212

ELITECHGROUP INC.

2023-08-14

Cytopro Dual Cytopad, fast, white, pack of 100 - SS-211

ELITECHGROUP INC.

2023-08-14

Cytopro Dual Sample Chamber Caps, Pack of 48 - SS-210

ELITECHGROUP INC.

2023-08-14

Microscope slides, 1/2G, coated, for Cytopro - Microscope slides, 1/2G, coated, for Cytopro. Slides are used to collect the material centrifuged out of the solutions contained in the sample chambers. Slides are designed specifically for single, double, or magnum chambers and come in coated and uncoated versions for each.

ELITECHGROUP INC.

2023-08-14

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