Checkcell 0002225

GUDID 10888234000198

Checkcell is used to confirm the validity of negative antiglobulin tests. Checkcell is a single vial pool of group O red blood cells that have been se

IMMUCOR, INC.

Multiple immunohaematology test IVD, control

• Primary Device ID: 10888234000198
• NIH Device Record Key: ad564e5c-8722-404e-b87c-714128e8a063
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Checkcell
• Version Model Number: 0002225
• Catalog Number: 0002225
• 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	10888234000198 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• BK110050

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: 2016-04-15

On-Brand Devices [Checkcell]

• 10888234000198: Checkcell is used to confirm the validity of negative antiglobulin tests. Checkcell is a single
• 10888234000181: Checkcell is used to confirm the validity of negative antiglobulin tests. Checkcell is a single