HELMED® AUTOMATED IFA PROCESSOR REF.HEL-1000

GUDID 04250289512565

Aesku.Diagnostics GmbH & Co. KG

Specimen processing instrument IVD Specimen processing instrument IVD Specimen processing instrument IVD Specimen processing instrument IVD Specimen processing instrument IVD Specimen processing instrument IVD Specimen processing instrument IVD Specimen processing instrument IVD Specimen processing instrument IVD Specimen processing instrument IVD Specimen processing instrument IVD Specimen processing instrument IVD Specimen processing instrument IVD Specimen processing instrument IVD Specimen processing instrument IVD Specimen processing instrument IVD Specimen processing instrument IVD

• Primary Device ID: 04250289512565
• NIH Device Record Key: bd06d19b-d516-4986-bffe-d74031a1f4ab
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HELMED® AUTOMATED IFA PROCESSOR
• Version Model Number: REF.HEL-1000
• Catalog Number: REF.HEL-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: 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	04250289512565 [Primary]

FDA Product Code

• JQW: Station, Pipetting And Diluting, 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
• 04250289512565 - HELMED® AUTOMATED IFA PROCESSOR: 2023-07-03
• 04250289512565 - HELMED® AUTOMATED IFA PROCESSOR: 2023-07-03
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• 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