Specimen Diluent 0066053

GUDID 10888234001072

Specimen Diluent is a ready for use isotonic solution used for diluting red blood cells from blood samples for testing on Immucor automated instruments. This product configuration is six (6) vials of 57 mL volume.

IMMUCOR, INC.

Blood cell preservation/storage/dilution solution IVD Blood cell preservation/storage/dilution solution IVD Blood cell preservation/storage/dilution solution IVD Blood cell preservation/storage/dilution solution IVD Blood cell preservation/storage/dilution solution IVD Blood cell preservation/storage/dilution solution IVD Blood cell preservation/storage/dilution solution IVD Blood cell preservation/storage/dilution solution IVD Blood cell preservation/storage/dilution solution IVD Blood cell preservation/storage/dilution solution IVD Blood cell preservation/storage/dilution solution IVD Blood cell preservation/storage/dilution solution IVD Blood cell preservation/storage/dilution solution IVD Blood cell preservation/storage/dilution solution IVD Blood cell preservation/storage/dilution solution IVD Blood cell preservation/storage/dilution solution IVD Cell preservation/storage/dilution solution IVD

• Primary Device ID: 10888234001072
• NIH Device Record Key: 19919d41-dbf6-44c3-aba2-0496e4bd84ec
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Specimen Diluent
• Version Model Number: 0066053
• Catalog Number: 0066053
• 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: true
• Donation Id Number: false
• Contains Natural Rubber Latex: true
• 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
• Phone: 1-855-466-8267
• Email: tech_support@immucor.com
• Phone: 1-855-466-8267
• Email: tech_support@immucor.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 1 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 10 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	10888234001072 [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: 4
• Public Version Date: 2019-11-27
• Device Publish Date: 2016-04-18

On-Brand Devices [Specimen Diluent]

• 10888234001072: Specimen Diluent is a ready for use isotonic solution used for diluting red blood cells from blo
• 10888234001065: Specimen Diluent is a ready for use isotonic solution used for diluting red blood cells from blo