EUROArrayProcessor Pre-PCR Software

GUDID 04049016151012

EUROIMMUN Medizinische Labordiagnostika AG

Microplate digital imaging scanner IVD Microplate digital imaging scanner IVD Microplate digital imaging scanner IVD Microplate digital imaging scanner IVD Microplate digital imaging scanner IVD Microplate digital imaging scanner IVD Microplate digital imaging scanner IVD Microplate digital imaging scanner IVD Microplate digital imaging scanner IVD Microplate digital imaging scanner IVD Microplate digital imaging scanner IVD Microplate digital imaging scanner IVD Microplate digital imaging scanner IVD Microplate digital imaging scanner IVD Microplate digital imaging scanner IVD Microplate digital imaging scanner IVD Microplate digital imaging scanner IVD Laboratory instrument/analyser application software IVD Laboratory instrument/analyser application software IVD Laboratory instrument/analyser application software IVD Laboratory instrument/analyser application software IVD Laboratory instrument/analyser application software IVD Laboratory instrument/analyser application software IVD Laboratory instrument/analyser application software IVD Laboratory instrument/analyser application software IVD Laboratory instrument/analyser application software IVD Laboratory instrument/analyser application software IVD Laboratory instrument/analyser application software IVD Laboratory instrument/analyser application software IVD Laboratory instrument/analyser application software IVD Laboratory instrument/analyser application software IVD Laboratory instrument/analyser application software IVD Laboratory instrument/analyser application software IVD

• Primary Device ID: 04049016151012
• NIH Device Record Key: fd91cda0-50ee-422d-8dec-df7defd97f39
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EUROArrayProcessor Pre-PCR Software
• Version Model Number: YG 0671-0101-2
• 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: false
• 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	04049016151012 [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: 2023-03-13
• Device Publish Date: 2023-03-03

Devices Manufactured by EUROIMMUN Medizinische Labordiagnostika AG

• 04049016125228 - EUROArrayScanner: 2023-11-28
• 04049016159704 - EUROPLUS Granulocyte Mosaic 32: 2023-10-13
• 04049016159018 - UNIQO 160: 2023-09-28
• 04049016152989 - IFA: Crithidia luciliae sensitive (anti-dsDNA) EUROPattern: 2023-07-13
• 04049016069355 - Adjustment solution: 2023-06-02
• 04049016151821 - Adjustment solution: 2023-06-02
• 04049016137740 - Free Testosterone ELISA: 2023-05-03
• 04049016140085 - Total Testosterone ELISA: 2023-05-03