Capture-R Ready-Screen (I and II) 0006439

GUDID 10888234000631

Capture-R Ready-Screen (I and II) is intended for use in the detection of unexpected IgG antibodies to red blood cells by manual, semi-automated or au

IMMUCOR, INC.

Solid phase red blood cell adherence antibody/antigen IVD Solid-phase red blood cell adherence antibody/antigen IVD Solid-phase red blood cell adherence antibody/antigen IVD Solid-phase red blood cell adherence antibody/antigen IVD Solid-phase red blood cell adherence antibody/antigen IVD Solid-phase red blood cell adherence antibody/antigen IVD Solid-phase red blood cell adherence antibody/antigen IVD Solid-phase red blood cell adherence antibody/antigen IVD Solid-phase red blood cell adherence antibody/antigen IVD Solid-phase red blood cell adherence antibody/antigen IVD Solid-phase red blood cell adherence antibody/antigen IVD Solid-phase red blood cell adherence antibody/antigen IVD Solid-phase red blood cell adherence antibody/antigen IVD

• Primary Device ID: 10888234000631
• NIH Device Record Key: 43bbfb83-6d4b-4e29-b451-5c3421a18bfd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Capture-R Ready-Screen (I and II)
• Version Model Number: 0006439
• Catalog Number: 0006439
• 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: 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	10888234000631 [Primary]

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-04-14

On-Brand Devices [Capture-R Ready-Screen (I and II)]

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• 10888234000648: Capture-R Ready-Screen (I and II) is intended for use in the detection of unexpected IgG antibod
• 10888234000631: Capture-R Ready-Screen (I and II) is intended for use in the detection of unexpected IgG antibod