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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)

Page 1 of 5

Device	Model / Reference	Registries	Class	Status
Macroduct® Collection Strap Set, S, M, L, XL	SS-259	FDA UDI	Class II	Active
Excyte	Mini (9mm)	FDA UDI	Class I	Active
Nanoduct® Electrode Cable Set Assembly	RP-359	FDA UDI	Class II	Active
Excyte® ESR Non-Vacuum Tubes	EX-50100	FDA UDI	Class I	Active
Dual Sample Chambers w/ fast, white Cytopads, pk48	SS-215	FDA UDI	Class I	Active
Cytopro Dual Cytopad, fast, white, pack of 100	SS-211	FDA UDI	Class I	Active
Sample Chambers w/ slow, tan Cytopads, pack of 48	SS-116	FDA UDI	Class I	Active
Accu-Sed® Plus Norm & Abn ESR Control Kit, 2x8.5mL	DS-71004	FDA UDI	Class I	Active
Excyte® ESR Vacuum Tube, Carton	EP-10605-H1	FDA UDI	Class I	Active
MGB Alert® BKV Probe Mix ASR - 480 Reactions QTY-100	800333-100	FDA UDI	Class I	Active
Nanoduct® Attachment Strap Retainer Post, Qty 1	RP-353	FDA UDI	Class II	Active
FreezePoint® Freezing Point Osmometer	Model 6000P	FDA UDI	Class I	Active
Macroduct® Collector, w/o Dye, Qty 1	SS-142-ND	FDA UDI	Class II	Active
Carbon Dioxide Electrode	275-001	FDA UDI	Class II	Active
Chloride Electrode	280-001	FDA UDI	Class II	Active
Dual Sample Chambers w/ slow, tan pads, caps, pk/48	SS-214	FDA UDI	Class I	Active
Macroduct® Pilogel Discs	SS-023	FDA UDI	Class II	Active
ELITe InGenius® SP 200	INT032SP200	FDA UDI	Class II	Active
Direct A1c Control Kit	55136	FDA UDI	Class II	Active
Nanoduct® Neg (-) Black Holder, Qty 1	RP-358	FDA UDI	Class II	Active
Microscope slides, 1/2G, uncoated, for Cytopro	SS-117	FDA UDI	Class I	Active
MGB Alert® CMV 3.0 Primer Mix ASR - 480 Reactions QTY-25	800350-25	FDA UDI	Class I	Active
Monosed® ESR Vacuum Tubes	PRD-PRV11B-50	FDA UDI	Class I	Active
MGB Alert® BKV Primer Mix ASR - 480 Reactions QTY 25	800332-25	FDA UDI	Class I	Active
ELITe InGenius® PCR cassette	INT035PCR	FDA UDI	Class II	Active
Excyte® ESR Vacuum Tubes, Carton	EX-50205	FDA UDI	Class I	Active
Accu-Sed® Plus Abnormal ESR Control Kit, 5x8.5mL	DS-71003	FDA UDI	Class I	Active
MGB Alert® BKV Primer Mix ASR - 480 Reactions QTY 100	800332-100	FDA UDI	Class I	Active
Monosed® ESR Vacuum Tubes, Carton	PRD-PRV11B-50	FDA UDI	Class I	Active
Excyte® ESR Vacuum Tube	EP-10605	FDA UDI	Class I	Active
Excyte® ESR Vacuum Tube	EP-10605-H1	FDA UDI	Class I	Active
Cytopro Magnum Sample Chambers w/ caps	SS-234	FDA UDI	Class I	Active
Sample Chambers w/ fast, white Cytopads, pack/48	SS-115	FDA UDI	Class I	Active
Excyte 20	20 (9 mm)	FDA UDI	Class I	Active
Macroduct Advanced Sweat Collection System	Model 3710-Sys	FDA UDI	Class II	Active
MGB Alert IC1 Internal Control Template (35uL volume)	M800735	FDA UDI	Class I	Active
Macroduct® Advanced Supply Kit, w/o Dye, Qty 6	SS-268-ND	FDA UDI	Class II	Active
Macroduct® Advanced Electrode Cable Assembly	RP-537	FDA UDI	Class II	Unknown
Dual Sample Chambers w/ slow, tan Cytopads, pk/48	SS-216	FDA UDI	Class I	Active
MGB Alert® BKV Probe Mix ASR - 480 Reactions QTY-25	800333-25	FDA UDI	Class I	Active
MGB Alert Internal Control Set IC2-B, 480 rxn QTY-100	800363-100	FDA UDI	Class I	Active
MGB Alert® CMV 3.0 Probe Mix ASR - 480 Reactions QTY-100	800404-100	FDA UDI	Class I	Active
Macroduct® Black Electrode Strap, Qty 1	RP-381	FDA UDI	Class II	Active
Macroduct® Collection Strap, Large, Qty 1	SS-257	FDA UDI	Class II	Active
Microscope Slides, 1/2G, uncoated, Cytopro Dual	SS-117	FDA UDI	N/A	Active
Nanoduct® Conductivity Sensor Cell, Qty 1	SS-231	FDA UDI	Class II	Active
Nanoduct® Electrode Strap, Medium, Qty 1	RP-355	FDA UDI	Class II	Active
Excyte 20	20 (8 mm)	FDA UDI	Class I	Active
Macroduct® Supply Kit, Qty 6	SS-032	FDA UDI	Class II	Active
Monosed® ESR Vacuum Tubes, Carton	PRD-PRV11V-H12	FDA UDI	Class I	Active

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