Galileo Echo 0087000

GUDID 10888234001584

The Galileo Echo is a microprocessor-controlled instrument designed to fully automate immunohematology in vitro diagnostic testing of human blood. The

IMMUCOR, INC.

Immunohaematology/blood bank analyser IVD, automated Immunohaematology/blood bank analyser IVD Immunohaematology/blood bank analyser IVD Immunohaematology/blood bank analyser IVD Immunohaematology/blood bank analyser IVD Immunohaematology/blood bank analyser IVD Immunohaematology/blood bank analyser IVD Immunohaematology/blood bank analyser IVD Immunohaematology/blood bank analyser IVD Immunohaematology/blood bank analyser IVD Immunohaematology/blood bank analyser IVD Immunohaematology/blood bank analyser IVD Immunohaematology/blood bank analyser IVD Immunohaematology/blood bank analyser IVD Immunohaematology/blood bank analyser IVD

• Primary Device ID: 10888234001584
• NIH Device Record Key: 456fae1e-e33f-4b7c-8250-eea0a084be81
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Galileo Echo
• Version Model Number: 0087000
• Catalog Number: 0087000
• 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: true
• 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

Customer Support Contacts

• Phone: 1-855-466-8267
• Email: tech_support@immucor.com
• Phone: 1-855-466-8267
• Email: tech_support@immucor.com
• Phone: 1-855-466-8267
• Email: tech_support@immucor.com
• Phone: 1-855-466-8267
• Email: tech_support@immucor.com
• Phone: 1-855-466-8267
• Email: tech_support@immucor.com
• Phone: 1-855-466-8267
• Email: tech_support@immucor.com
• Phone: 1-855-466-8267
• Email: tech_support@immucor.com
• Phone: 1-855-466-8267
• Email: tech_support@immucor.com
• Phone: 1-855-466-8267
• Email: tech_support@immucor.com
• Phone: 1-855-466-8267
• Email: tech_support@immucor.com
• Phone: 1-855-466-8267
• Email: tech_support@immucor.com
• Phone: 1-855-466-8267
• Email: tech_support@immucor.com
• Phone: 1-855-466-8267
• Email: tech_support@immucor.com
• Phone: 1-855-466-8267
• Email: tech_support@immucor.com
• Phone: 1-855-466-8267
• Email: tech_support@immucor.com

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *This is an automated laboratory instrument.
• Special Storage Condition, Specify: Between 0 and 0 *This is an automated laboratory instrument.
• Special Storage Condition, Specify: Between 0 and 0 *This is an automated laboratory instrument.
• Special Storage Condition, Specify: Between 0 and 0 *This is an automated laboratory instrument.
• Special Storage Condition, Specify: Between 0 and 0 *This is an automated laboratory instrument.
• Special Storage Condition, Specify: Between 0 and 0 *This is an automated laboratory instrument.
• Special Storage Condition, Specify: Between 0 and 0 *This is an automated laboratory instrument.
• Special Storage Condition, Specify: Between 0 and 0 *This is an automated laboratory instrument.
• Special Storage Condition, Specify: Between 0 and 0 *This is an automated laboratory instrument.
• Special Storage Condition, Specify: Between 0 and 0 *This is an automated laboratory instrument.
• Special Storage Condition, Specify: Between 0 and 0 *This is an automated laboratory instrument.
• Special Storage Condition, Specify: Between 0 and 0 *This is an automated laboratory instrument.
• Special Storage Condition, Specify: Between 0 and 0 *This is an automated laboratory instrument.
• Special Storage Condition, Specify: Between 0 and 0 *This is an automated laboratory instrument.
• Special Storage Condition, Specify: Between 0 and 0 *This is an automated laboratory instrument.

Device Identifiers

Device Issuing Agency	Device ID
GS1	10888234001584 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• BK070016

FDA Product Code

• KSZ: System, Test, Automated Blood Grouping And Antibody

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-04-18

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