Capture-R Select 0006446

GUDID 10888234000655

Capture-R Select solid phase system provides modified micro-wells for the immobilization of human erythrocytes for use in solid phase assays for the d

IMMUCOR, INC.

Microplate IVD

• Primary Device ID: 10888234000655
• NIH Device Record Key: f9cfad0c-c88e-47d0-8dfb-f610b306e609
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Capture-R Select
• Version Model Number: 0006446
• Catalog Number: 0006446
• 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	10888234000655 [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: 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 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