Capture-R Select 0066903

GUDID 10888234001553

The Capture-R Select Solid Phase System provides modified microwells for the immobilization of human erythrocytes for use in solid phase assays for the detection of IgG red blood cell antibodies to corresponding red blood cell antigens (e.g., antibody screening, selected red blood cell panels, crossmatching, or antigen phenotyping).

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

• Primary Device ID: 10888234001553
• NIH Device Record Key: 24c60f82-e0b9-447b-9edd-2e5bb42c31e5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Capture-R Select
• Version Model Number: 0066903
• Catalog Number: 0066903
• 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: 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	10888234001553 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• BK040024

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: 2022-09-12
• Device Publish Date: 2022-09-03

On-Brand Devices [Capture-R Select]

• 10888234000655: Capture-R Select solid phase system provides modified micro-wells for the immobilization of huma
• 10888234001553: The Capture-R Select Solid Phase System provides modified microwells for the immobilization of h