HERA

GUDID 04250289512909

Aesku.Diagnostics GmbH & Co. KG

Clinical management support software IVD

• Primary Device ID: 04250289512909
• NIH Device Record Key: 0b4afa88-3bca-4a1d-913d-08c533826797
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HERA
• Version Model Number: REF.HER-1000
• Company DUNS: 341714388
• Company Name: Aesku.Diagnostics GmbH & Co. KG
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	04250289512909 [Primary]

FDA Product Code

• JQP: Calculator/Data Processing Module, 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: 2023-07-28
• Device Publish Date: 2023-07-20

Devices Manufactured by Aesku.Diagnostics GmbH & Co. KG

• 04250289513531 - HELMED® Automated IFA Processor: 2025-01-13
• 04260186120008 - HELIOS® Automated IFA System: 2025-01-13
• 04250289513401 - AESKUSLIDES® nDNA (Crithidia luciliae): 2024-11-25 AESKUSLIDES® nDNA (Crithidia luciliae) is an indirect immunofluorescence assay utilizing Crithidia luciliae coated slides as a
• 04250289512909 - HERA: 2023-07-28
• 04250289512909 - HERA: 2023-07-28
• 04250289512541 - HELIOS® AUTOMATED IFA SYSTEM: 2023-07-03
• 04250289512565 - HELMED® AUTOMATED IFA PROCESSOR: 2023-07-03
• 04250289500005 - AESKUSLIDES® ANA-HEp-2: 2018-07-06 AESKUSLIDES ANA-HEp-2 is an indirect immunofluorescence assay to detect nuclear and / or cytoplasmic autoantibodies in human ser
• 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