Capture-R Ready Indicator Red Cells 0066907

GUDID 10888234002307

Anti-IgG-coated Indicator Red Cells for use in Capture-R Ready-Screen, Capture-R Ready-ID or Capture-R Select Solid Phase Assays for the detection of IgG antibodies to red blood cells.

IMMUCOR, INC.

Monospecific immunoglobulin G antihuman globulin (IgG AHG) IVD, antibody Monospecific immunoglobulin G antihuman globulin (IgG AHG) IVD, antibody Monospecific immunoglobulin G antihuman globulin (IgG AHG) IVD, antibody Monospecific immunoglobulin G antihuman globulin (IgG AHG) IVD, antibody Monospecific immunoglobulin G antihuman globulin (IgG AHG) IVD, antibody Monospecific immunoglobulin G antihuman globulin (IgG AHG) IVD, antibody Monospecific immunoglobulin G antihuman globulin (IgG AHG) IVD, antibody Monospecific immunoglobulin G antihuman globulin (IgG AHG) IVD, antibody Monospecific immunoglobulin G antihuman globulin (IgG AHG) IVD, antibody Monospecific immunoglobulin G antihuman globulin (IgG AHG) IVD, antibody Monospecific immunoglobulin G antihuman globulin (IgG AHG) IVD, antibody Monospecific immunoglobulin G antihuman globulin (IgG AHG) IVD, antibody Monospecific immunoglobulin G antihuman globulin (IgG AHG) IVD, antibody Monospecific immunoglobulin G antihuman globulin (IgG AHG) IVD, antibody Monospecific immunoglobulin G antihuman globulin (IgG AHG) IVD, antibody

• Primary Device ID: 10888234002307
• NIH Device Record Key: 3995a7bd-73af-48f0-8abe-bbd5f0fa69cb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Capture-R Ready Indicator Red Cells
• Version Model Number: 0066907
• Catalog Number: 0066907
• 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	10888234002307 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• BK020053

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: 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 Ready Indicator Red Cells]

• 10888234000600: This product is Anti-IgG-coated Indicator Red Cells for use in Capture-R Ready-Screen, Capture-R
• 10888234000594: This product is Anti-IgG-coated Indicator Red Cells for use in Capture-R Ready-Screen, Capture-R
• 10888234002307: Anti-IgG-coated Indicator Red Cells for use in Capture-R Ready-Screen, Capture-R Ready-ID or Cap