HELIOS® AUTOMATED IFA SYSTEM REF.IOS-1000

GUDID 04250289512541

Aesku.Diagnostics GmbH & Co. KG

Fluorescent immunoassay analyser IVD, laboratory

• Primary Device ID: 04250289512541
• NIH Device Record Key: 57490d14-54b3-4938-839a-cc80632096f9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HELIOS® AUTOMATED IFA SYSTEM
• Version Model Number: REF.IOS-1000
• Catalog Number: REF.IOS-1000
• Company DUNS: 341714388
• Company Name: Aesku.Diagnostics 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: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	04250289512541 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K153117

FDA Product Code

• 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: 2023-07-03
• Device Publish Date: 2023-06-25

On-Brand Devices [HELIOS® AUTOMATED IFA SYSTEM]

• 04250289512541: REF.IOS-1000
• 04260186120008: REF.IOS-1000.US