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ELITECHGROUP INC.

United States·US-MF-000006942

Last updated May 24, 2026

What ELITECHGROUP INC. makes

Elitechgroup Inc. manufactures sweat-induction iontophoresis systems and devices, including collection straps, electrode cable sets, and attachment strap retainers. They also produce cytological centrifuge funnels, microscope slide stainers, and dual sample chambers with Cytopads for laboratory use. Their portfolio includes evacuated and non-vacuum erythrocyte sedimentation rate (ESR) tubes, ESR analysers, and related control kits such as the Accu-Sed® Plus Norm & Abn ESR Control Kit. Additionally, they supply exogenous DNA/RNA internal control IVD kits, including the MGB Alert® BKV Probe Mix ASR, and freezing point osmometers like the FreezePoint® device.

The company's devices span multiple regulatory classes, including Class A, Class I, Class II, Class IIa, and IVD General. These products are listed in regulatory databases such as Eudamed and the FDA's UDI system. Elitechgroup Inc. is based in the United States.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Frequently asked questions

What types of devices does Elitechgroup Inc. manufacture?

Elitechgroup Inc. manufactures sweat-induction iontophoresis systems and devices, cytological centrifuge funnels, microscope slide stainers, evacuated and non-vacuum erythrocyte sedimentation rate (ESR) tubes, ESR analysers, exogenous DNA/RNA internal control IVD kits, and freezing point osmometers. These products are used for diagnostic and laboratory purposes, including sample collection, preparation, and analysis.

Where is Elitechgroup Inc. based?

Elitechgroup Inc. is based in the United States, as stated in the company summary. This location informs the regulatory frameworks under which its devices may be listed, such as the FDA’s UDI system, though the company itself is not approved or cleared—only individual devices may be authorised.

In which regulatory registries are Elitechgroup Inc.'s devices listed?

Elitechgroup Inc.'s devices are listed in Eudamed and the FDA's UDI system. These registries track device information for regulatory oversight, but listing does not imply company-wide approval; only specific devices may be authorised under applicable regulations.

How are Elitechgroup Inc.'s devices classified under regulatory systems?

Elitechgroup Inc.'s devices span multiple regulatory classes, including Class A, Class I, Class II, Class IIa, and IVD General. Classification depends on the device’s intended use and risk level, and each device is assessed individually—no blanket classification applies to the company as a whole.

AI-generated from registry data and not verified by a human reviewer.

Information

Country: United States
Address: 370 West, 1700 South, Logan, United States
Website: www.elitechgroup.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: +1 435 752 4127
PRRC Contact: Robert Ortiz
EUDAMED SRN: US-MF-000006942
FDA FEI Number: —
DUNS Number: 052423787

Catalogue (217)

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Device	Model / Reference	Registries	Class	Status
Cytopro Cytopad, fast, white, package of 100	SS-111	FDA UDI	Class I	Active
Nanoduct® Supply Kit, Qty 6	SS-043	FDA UDI	Class II	Active
Cytopro Dual Sample Chamber Caps, Pack of 48	SS-210	FDA UDI	Class I	Active
Potassium Electrode	279-001	FDA UDI	Class II	Active
Excyte® ESR Non-Vacuum Tubes, Carton	EX-50100	FDA UDI	Class I	Active
Sodium Electrode	278-001	FDA UDI	Class II	Active
ELITe InGenius® Waste Box	F2102-000	FDA UDI	Class II	Active
Cytopro Single Sample Chamber Caps, pack of 48	SS-110	FDA UDI	Class I	Active
Nanoduct® Electrode Strap, Small, Qty 1	RP-354	FDA UDI	Class II	Active
Mix-Rate® X20 Automated ESR Analyzer	PRD-X20-EL-08TKNE	FDA UDI	Class I	Active
Macroduct® Collection Strap, Medium, Qty 1	SS-256	FDA UDI	Class II	Active
Nanoduct® Pos (+) Red Holder, Qty 1	RP-357	FDA UDI	Class II	Active
ChloroChek® Reagent Set, 37x10mL BS + 1x30mL GS	SS-248	FDA UDI	Class II	Active
Microsed-System® Automated ESR Analyzer	PRD-MSS-EL-08TKNE	FDA UDI	Class I	Active
Macroduct® Advanced Supply Kit, Qty 6	SS-268	FDA UDI	Class II	Active
Direct A1c Calibrator Kit	55120	FDA UDI	Class II	Active
Macroduct® Sweat Collection System	Model 3700	FDA UDI	Class II	Active
MGB Alert Internal Control Set IC2-B, 480 rxn QTY-25	800363-25	FDA UDI	Class I	Active
Accu-Sed® Plus Norm & Abn ESR Control Set, 10x8.5mL	DS-71005A	FDA UDI	Class I	Active
Nanoduct® Calibration Standard Plate	AC-081	FDA UDI	Class II	Active
Macroduct® Electrode Cable Assembly	RP-383	FDA UDI	Class II	Active
Excyte® ESR Vacuum Tubes	EX-50205	FDA UDI	Class I	Active
ELITe InGenius®	INT030-K	FDA UDI	Class II	Active
Macroduct® Red Electrode Strap, Qty 1	RP-382	FDA UDI	Class II	Active
MGB Alert Internal Control Set IC2-C -480 rxn QTY-100	800432-100	FDA UDI	Class I	Active
MGB Alert® CMV 3.0 Probe Mix ASR - 480 Reactions QTY-25	800404-25	FDA UDI	Class I	Active
Sample Chambers w/ fast, white Cytopads, caps, pk48	SS-113	FDA UDI	Class I	Active
Microscope slides, 1/2G, coated, for Cytopro	SS-118	FDA UDI	Class I	Active
Nanoduct Neonatal Sweat Analysis System	Nanoduct Sys 1030	FDA UDI	Class II	Active
Macroduct® Collection Strap, XLarge, Qty 1	SS-258	FDA UDI	Class II	Active
MGB Alert® CMV 3.0 Primer Mix ASR - 480 Reactions QTY-100	800350-100	FDA UDI	Class I	Active
Accu-Sed® Plus Normal ESR Control Kit, 5x8.5mL	DS-71002	FDA UDI	Class I	Active
Take-up Tubes, 14 inch, Qty 100	SS-044	FDA UDI	Class II	Active
Excyte	Mini (8mm)	FDA UDI	Class I	Active
ELITe InGenius® SP 200 Consumable Set	INT032CS	FDA UDI	Class II	Active
Nanoduct® Electrode Strap, Large, Qty 1	RP-356	FDA UDI	Class II	Active
Excyte	Duo-Mix	FDA UDI	Class I	Unknown
Accu-Sed® Test Kit, 4x8.5mL 2 Normal & 2 Abnormal	DS-71006	FDA UDI	Class I	Active
Cytopro Dual Cytopad, slow, tan, pack of 100	SS-212	FDA UDI	N/A	Active
Cytopro Cytopad, slow, tan, package of 100	SS-112	FDA UDI	Class I	Active
Sweat-Chek™ Sweat Conductivity Analyzer	Model 3120	FDA UDI	Class II	Active
Sweat-Chek™ Calibrator, 90 mmol/L, 60 x 0.75mL	SS-140	FDA UDI	Class II	Active
Dual Sample Chambers w/ fast, white pads, caps, 48	SS-213	FDA UDI	Class I	Active
MGB Alert Internal Control Set IC2-C -480 rxn QTY-25	800432-25	FDA UDI	Class I	Active
Macroduct® Collector, Qty 1	SS-142	FDA UDI	Class II	Active
FreezePoint® Freezing Point Osmometer	Model 6000S	FDA UDI	Class I	Active
Macroduct® Collection Strap, Small, Qty 1	SS-255	FDA UDI	Class II	Active
Direct A1c Reagent Kit	55370	FDA UDI	Class II	Active
Excyte® ESR Vacuum Tube, Carton	EP-10605	FDA UDI	Class I	Active
FreezePoint® Freezing Point Osmometer	Model 6000SP	FDA UDI	Class I	Active

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