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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
Sample Chambers w/Slow, Tan Cytopads, Caps, 48pk.	SS-114	FDA UDI	Class I	Active
FreezePoint® Freezing Point Osmometer	Model 6000	FDA UDI	Class I	Active
Macroduct® Supply Kit, w/o Dye, Qty 6	SS-032-ND	FDA UDI	Class II	Active
Aerospray Hematology Pro Reagent A, Buffer (pH 7.2),	SS-072A-EU	EUDAMED	Class A	Active
Aerospray® TB Reagent B, Thiazin Red	SS-061BRT-EU	EUDAMED	Class A	Active
Aerospray 30 Slide Carousel	AC-189	EUDAMEDFDA UDI	Class A	Active
Aerospray Hematology Pro Reagent B, Thiazin Stain	SS-071B-EU	EUDAMED	Class A	Active
Osmocoll HNL Osmolality Controls	SS-273	EUDAMEDFDA UDI	IVD General	Active
Aerospray* Cytology Stain B, Orange G Stain	SS-051B	EUDAMED	Class A	Active
Macroduct Advanced Strap Set, Qty 18	SS-269	EUDAMEDFDA UDI	Class I	Active
Aerospray® Gram Reagent A, Safranine Concentrate	SS-141A	EUDAMED	Class A	Active
Aerospray® Cytology Stain F, Acid Alcohol	SS-051F	EUDAMED	Class A	Active
Aerospray Hematology Stat Reagent A Basofix Rinse	SS-049A-EU	EUDAMED	Class A	Active
Sweat Controls, L1, L2, L3	SS-150	EUDAMEDFDA UDI	IVD General	Active
Aerospray Cytology 12-Slide Carousel	AC-195	EUDAMEDFDA UDI	Class A	Active
ELITech Clinical Systems GLUCOSE HK SL, ELITech Clinical Systems ELICAL 2, ELITech Clinical Systems ELITROL I and ELITROL II	K153644	FDA 510(k)	Class II	Active
Elittech Clinical Systems Alp Ifcc Sl	K113269	FDA 510(k)	Class II	Active
ELITech Clinical Systems BILIRUBIN TOTAL 4+1, ELITech Clinical Systems BILIRUBIN DIRECT 4+1	K171401	FDA 510(k)	Class II	Active
HSV 1 & 2 ELITe MGB Kit; ELITe InGenius	K180559	FDA 510(k)	Class II	Active
Elitech Clinical Systems Elical 2, Elitech Clinical Systems Elitrol I, Elitech Clinical Systems Elitrol Ii Model Cali-05	K112029	FDA 510(k)	Class II	Active
Elitech Clinical Systems Ck Nac Sl	K122083	FDA 510(k)	Class II	Active
ELITech Clinical Systems CALCIUM ARSENAZO	K151113	FDA 510(k)	Class II	Active
Elitech Clinical Systems Bilirubin Total 4+1, Elitech Clinical Systems Elical 2, Elitech Clinical Systmes Elitrol I & Ii	K110780	FDA 510(k)	Class II	Active
Elitech Clinical Systems Elical 2; Elitech Clinical Systems Elitrol I, Elitech Clinical Systems Elitrol Ii	K130765	FDA 510(k)	Class II	Active
Elitech Clinical Sysems Ise Control 1 And 2	K111996	FDA 510(k)	Class I	Active
Elitech Clinical Systems Creatinine Pap Sl, Elical 2, Elitrol I And Elitrol Ii, Urine Control Bi-Level	K132399	FDA 510(k)	Class II	Active
Eltech Chinical System Amylase Sl Elitech Clinical Systems Elical2 Eltech Clinical Systems Elitrol I And Elitrol Ii	K122858	FDA 510(k)	Class II	Active
Elitech Clinical Systems Urine Total Protein Plus Standard 100 Mg/Dl, Elitech Clinical Systems Urine Control Bi-Level	K122177	FDA 510(k)	Class II	Active
ELITech Clinical Systems ELICAL 2, ELITech Clinical Systems ELITROL I, ELITech Clinical Systems ELITROL II	K151552	FDA 510(k)	Class II	Active
Elitech Clinical Systems Envoy 500 Ck Reagent Kit	K141265	FDA 510(k)	Class II	Active
Elitech Clinical Systems Calcium Arsenazo; Elitech Clinical Systems Albumin; Elitech Clinical Systems Elical 2; Elitech	K110830	FDA 510(k)	Class II	Active
Elitech Clinical Systems Carbon Dioxide Electrode, Elitech Clinical Systems Ise Calibrators	K111960	FDA 510(k)	Class II	Active
Aerospray Hematology Stat Reagent A, Rinse Concentrate	SS-135/149A	EUDAMED	Class A	Active
Aerospray Hematology Pro Reagent A, Buffer (pH 6.8) Concentrate	SS-171A-EU	EUDAMED	Class A	Active
Macroduct Advanced Strap Set, Qty 180	SS-270	EUDAMEDFDA UDI	Class I	Active
Aerospray Reagent Grade Methanol	SS-MeOH	EUDAMED	Class A	Active
Aerospray® TB Reagent A, Carbol Fuchsin Decolorizer	SS-061A-EU	EUDAMED	Class A	Active
Cytopro Rotor	AC-160	EUDAMEDFDA UDI	Class A	Active
Aerospray Hematology Pro Slide Stainer/Cytocentrifuge	Model 7152	EUDAMEDFDA UDI	Class A	Active
Optimole Osmolality Standard 100 mmol/kg	OA-010	EUDAMEDFDA UDI	IVD General	Active
Aerospray Hematology Stat Reagent C, Eosin Stain	SS-035C-EU	EUDAMED	Class A	Active
Aerospray Hematology Stat, Basofix Pre-dip Fixative Concentrate	SS-149P	EUDAMED	Class A	Active
Aerospray Gram Reagent A, Decolorizer with Fuchsin	SS-041AF	EUDAMED	Class A	Active
Aerospray® TB Reagent B, Methylene Blue	SS-061BMB-EU	EUDAMED	Class A	Active
Aerospray TB, Mycohold Cell Adhesive	SS-061M	EUDAMED	Class A	Active
Aerospray® TB, Mycohold™, Cell Adhesive Concentrate	SS-161M	EUDAMED	Class A	Active
Aerospray® Cytology Stain D, Hematoxylin II	SS-051D2	EUDAMED	Class A	Active
Aerospray® TB Reagent C, ELITe ZN	SS-061CEZ-EU	EUDAMED	Class A	Active
Aerospray Gram Reagent C, Crystal Violet	SS-041C	EUDAMED	Class A	Active
Aerospray® TB Reagent A, Fluorescence Decolorizer	SS-061AF	EUDAMED	Class A	Active

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