Capture-R Ready Indicator Red Cells 0006428

GUDID 10888234000600

This product is 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 t

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

• Primary Device ID: 10888234000600
• NIH Device Record Key: 6d9ecffd-003f-474f-9422-0712ee30561d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Capture-R Ready Indicator Red Cells
• Version Model Number: 0006428
• Catalog Number: 0006428
• 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
• 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 10 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 10 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	10888234000600 [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: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-04-15

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