Checkcell (Weak) 0002227

GUDID 10888234000211

Checkcell (Weak) is used to confirm the validity of negative antiglobulin tests. Checkcell (Weak) is a single vial pool of group O red blood cells tha

IMMUCOR, INC.

Multiple immunohaematology test IVD, control

• Primary Device ID: 10888234000211
• NIH Device Record Key: 0edb9104-1f8d-4556-9b24-091b780e87ce
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Checkcell (Weak)
• Version Model Number: 0002227
• Catalog Number: 0002227
• 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	10888234000211 [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 (Weak)]

• 10888234000211: Checkcell (Weak) is used to confirm the validity of negative antiglobulin tests. Checkcell (Weak
• 10888234000204: Checkcell (Weak) is used to confirm the validity of negative antiglobulin tests. Checkcell (Weak