ImmuLINK

GUDID 10888234002475

ImmuLINK is middleware software that allows the user to link the application software database on automated (and/or semi-automated) blood bank instruments; the user may also link the instrument database(s) with the user’s Laboratory Information System (LIS). ImmuLINK is software designed to provide an interface between the user, blood bank instruments, and Blood Establishment Computer. ImmuLINK allows integration of sample, donor, or patient data that has been collected from multiple sources and provides data management tools to create customizable reports from the diverse data.

IMMUCOR, INC.

Laboratory instrument/analyser application software IVD

• Primary Device ID: 10888234002475
• NIH Device Record Key: 75b748d6-9b76-4c3a-b3dc-9d30bf296d57
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ImmuLINK
• Version Model Number: 0030311
• Company DUNS: 061446282
• Company Name: IMMUCOR, INC.
• 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: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	10888234002475 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• BK230806

FDA Product Code

• MMH: Blood Establishment Computer Software And Accessories

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: 2024-12-13
• Device Publish Date: 2024-12-05

On-Brand Devices [ImmuLINK]

• 10888234001034: ImmuLINK stand-alone software is for use in a blood banking environment as an aid in interfacing
• 10888234002475: ImmuLINK is middleware software that allows the user to link the application software database o