helios new offen schraeg cropped

FDA clears Automated Vasculitis Test from AESKU

AESKU Receives FDA 510(k) Clearance for Anti-Neutrophil Cytoplasmic Antibody (ANCA) test to aid in the Diagnosis of ANCA Associated Vasculitides with the HELIOS Automated immunofluorescence assay (IFA) System

(Wendelsheim, Germany / Oakland, California) AESKU.GROUP – a science-focused manufacturer of autoimmune, allergy, and infectious disease diagnostics – received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for AESKUSLIDES ANCA Ethanol, and ANCA Formalin with the new HELIOS AUTOMATED IFA SYSTEM. Next to be submitted are esophageal and tissue section slides.

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nDNA (Crithidia luciliae) now FDA cleared with HELIOS

AESKU Receives FDA 510(k) Clearance for nDNA (Crithidia luciliae) with the HELIOS AUTOMATED IFA SYSTEM

HELIOS Introduction (English Language)

(Wendelsheim, Germany / Oakland, California,) AESKU.GROUP received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for AESKUSLIDES nDNA (Crithidia luciliae) with the new HELIOS AUTOMATED IFA SYSTEM. The kit is the second FDA cleared immunofluorescence assay on the HELIOS, after ANA HEp-2 (cleared in 2016), and will be followed by ANCA and tissue section slides.

HELIOS automated IFA System - now FDA cleared

helios fda closed image AESKU receives FDA 510(k) Clearance for HELIOS automated IFA System with AESKUSLIDES ANA HEp-2-Gamma

NEW | Pattern Recognition

The pattern recognition Add-ons give the HELIOS the ability to autonomously provide a suggestion of the most propable IFA pattern by analysing captured IFA images.

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NEW | Estimated Endpoint Titer

The Estimated Endpoint Titer option saves time and reagents. This option makes it easier to find the target solution and less dilution steps are needed.

The endpoint titer is defined as the highest dilution in which staining intensity is still detectable.

Abstracts

New diagnostics in Autoimmunity: A review and our Experience

Authors:
Boris Gilburd, Carlo Perricone, Enrica Cipriano, Nancy Agmon-Levin, Yehuda Shoenfeld

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A Reading and interpretation of ANA immunofluorescence tests: results of a comparative study with six automated systems

Authors:
Nicola Bizzaro, Stefan Platzgummer, Elio Tonutti, Antonio Antico, Danila Bassetti, Danilo Villalta, Fiorenza Pesente, Francesco Cucchiaro, Marilina Tampoia, Renato Tozzoli

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helios new offen schraeg cropped

FDA clears Automated Vasculitis Test from AESKU

Read more...

nDNA (Crithidia luciliae) now FDA cleared with HELIOS

AESKU Receives FDA 510(k) Clearance for nDNA (Crithidia luciliae) with the HELIOS AUTOMATED IFA SYSTEM

HELIOS Introduction (English Language)

HELIOS automated IFA System - now FDA cleared

helios fda closed image AESKU receives FDA 510(k) Clearance for HELIOS automated IFA System with AESKUSLIDES ANA HEp-2-Gamma

NEW | Pattern Recognition

The pattern recognition Add-ons give the HELIOS the ability to autonomously provide a suggestion of the most propable IFA pattern by analysing captured IFA images.

Read more...

NEW | Estimated Endpoint Titer

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Did you know?

You can hover the Mouse-pointer over the red dots ( ico 5 ) in the interactive HELIOS picture to activate detailed information regarding the serveral HELIOS features.

Did you know?

You can hover the Mouse-pointer over the red dots ( ico 5 ) in the interactive HELMED picture to activate detailed information regarding the serveral HELMED features.