HELIOS IOS-1000

GUDID 04260186125096

Automated system for immunofluorescence processing with an integral fluorescence microscope and software for routine laboratory use by professional users under controlled environmental conditions.

Aesku.Systems GmbH & Co. KG

Fluorescent immunoassay analyser IVD, laboratory, automated

• Primary Device ID: 04260186125096
• NIH Device Record Key: 53c87a5d-6ffb-45c8-93f5-2517f770e335
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HELIOS
• Version Model Number: AUTOMATED IFA SYSTEM
• Catalog Number: IOS-1000
• Company DUNS: 341702675
• Company Name: Aesku.Systems GmbH & Co. KG
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	04260186125096 [Primary]
GS1	42601861205090 [Previous]

FDA Product Code

• DHN: Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control
• PIV: Automated Indirect Immunofluorescence Microscope And Software-Assisted System For Clinical Use

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-03-10
• Device Publish Date: 2020-03-02

On-Brand Devices [HELIOS]

• 42601861205090: Automated system for immunofluorescence processing with an integrated fluorescence microscope an
• 04260186125096: Automated system for immunofluorescence processing with an integral fluorescence microscope and