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

Devices Manufactured by Aesku.Diagnostics GmbH & Co. KG

• 04250289512909 - HERA: 2023-07-28
• 04250289512541 - HELIOS® AUTOMATED IFA SYSTEM: 2023-07-03
• 04250289512541 - HELIOS® AUTOMATED IFA SYSTEM: 2023-07-03
• 04250289512565 - HELMED® AUTOMATED IFA PROCESSOR: 2023-07-03
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• 04250289500425 - AESKULISA® ANA-8Pro: 2018-07-06 AESKULISA ANA-8Pro is a solid phase enzyme immunoassay for the separate qualitative detection of IgG antibodies against eight ce
• 04250289500449 - AESKULISA® ENA-6S: 2018-07-06 AESKULISA ENA-6S is a solid phase enzyme immunoassay for the combined qualitative detection of IgG antibodies against six cellul
• 04250289500456 - AESKULISA® ENA-6Pro: 2018-07-06 AESKULISA ENA-6Pro is a solid phase enzyme immunoassay for the separate semiquantitative detection of IgG antibodies against six
• 04250289500463 - AESKULISA® U1-70: 2018-07-06 AESKULISA U1-70 is a solid phase enzyme immunoassay employing recombinant human 70 kDa protein of the U1-snRNP complex for the q