EUROArrayScanner

GUDID 04049016125228

EUROIMMUN Medizinische Labordiagnostika AG

Microscope slide digital imaging scanner IVD

• Primary Device ID: 04049016125228
• NIH Device Record Key: e98d66b9-929f-4adf-8d4d-d9f57f27023e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EUROArrayScanner
• Version Model Number: YG 0602-0101
• Company DUNS: 322209263
• Company Name: EUROIMMUN Medizinische Labordiagnostika AG
• 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	04049016125228 [Primary]

FDA Product Code

• NSU: Instrumentation For Clinical Multiplex Test Systems

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: 2023-11-28
• Device Publish Date: 2023-11-20

Devices Manufactured by EUROIMMUN Medizinische Labordiagnostika AG

• 04049016151876 - Sample buffer 2, Crithidia luciliae sensitive (IFA): 2025-03-14
• 04049016151890 - Sample buffer 2, Crithidia luciliae sensitive (IFA): 2025-03-14
• 04049016151920 - PBS-Tween (IFA): 2025-03-12
• 04049016151883 - Sample buffer (IFA): 2025-03-06
• 04049016151906 - Sample buffer (IFA): 2025-03-06
• 04049016151913 - Sample buffer (IFA): 2025-03-06
• 04049016151937 - PBS (IFA): 2025-03-06
• 04049016151944 - PBS (IFA): 2025-03-06