Capture-R Ready-Screen (3) 0066816

GUDID 10888234002369

Capture-R Ready-Screen (3) is used in the detection of unexpected IgG antibodies to red blood cells by manual, semi-automated or automated solid phase

IMMUCOR, INC.

Solid phase red blood cell adherence antibody/antigen IVD

• Primary Device ID: 10888234002369
• NIH Device Record Key: 2952ce7b-8d94-42bf-9401-678db5f6705a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Capture-R Ready-Screen (3)
• Version Model Number: 0066816
• Catalog Number: 0066816
• 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
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• 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

Operating and Storage Conditions

• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	10888234002369 [Primary]

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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2018-10-15
• Device Publish Date: 2018-09-12

On-Brand Devices [Capture-R Ready-Screen (3)]

• 10888234002369: Capture-R Ready-Screen (3) is used in the detection of unexpected IgG antibodies to red blood ce
• 10888234001935: Capture-R Ready-Screen (3) is used in the detection of unexpected IgG antibodies to red blood ce
• 10888234001478: Capture-R Ready-Screen (3) is used in the detection of unexpected IgG antibodies to red blood ce
• 10888234001461: Capture-R Ready-Screen (3) is used in the detection of unexpected IgG antibodies to red blood ce
• 10888234001454: Capture-R Ready-Screen (3) is used in the detection of unexpected IgG antibodies to red blood ce
• 10888234001423: Capture-R Ready-Screen (3) is used in the detection of unexpected IgG antibodies to red blood ce
• 10888234001416: Capture-R Ready-Screen (3) is used in the detection of unexpected IgG antibodies to red blood ce