Monoclonal Control 0066087

GUDID 10888234002178

Monoclonal Control is intended to be used as a control for Immucor low protein Blood Grouping Reagents and Gamma-clone blood grouping reagents used in

IMMUCOR, INC.

Multiple immunohaematology test IVD, control

• Primary Device ID: 10888234002178
• NIH Device Record Key: c9634a03-5a2b-427a-be8e-aa3b74155d88
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Monoclonal Control
• Version Model Number: 0066087
• Catalog Number: 0066087
• 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

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	10888234002178 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• BK040010

FDA Product Code

• KSF: Kit, Quality Control For Blood Banking Reagents

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

On-Brand Devices [Monoclonal Control]

• 10888234002178: Monoclonal Control is intended to be used as a control for Immucor low protein Blood Grouping Re
• 10888234001089: Monoclonal Control is intended to be used as a control for Immucor low protein Blood Grouping Re