Capture-R Ready-Screen (Pooled Cells)

Basic Information

• Brand Name: Capture-R Ready-Screen (Pooled Cells)
• Primary DI: 10888234001317
• Version / Model: 0066254
• Catalog Number: 0066254
• Company Name: IMMUCOR, INC.
• Labeler DUNS: 061446282
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-06-04
• Public Version: 3
• Public Version Date: 2021-07-08
• Public Version Status: Update
• Public Device Record Key: 098ceb20-4aaa-434b-8c17-462ae92d4c88

Device Description

Capture-R Ready-Screen (Pooled Cells) is used in the detection of unexpected IgG antibodies to red blood cells (in blood donors) by manual, semi-automated or automated solid phase red blood cell adherence methods. Each test well is prepared from a pool of two (2) group O donors. Each microplate strip consists of eight (8) individual wells to perform eight (8) antibody screens. Each microplate is packaged into a pouch. This particular product code package configuration is made up of five (5) microplates of the identical product, and the identical lot number, placed into the one (1) single box.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: Yes
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

GMDN Terms

Code	Name	Definition	Implantable	Status
58814	Solid-phase red blood cell adherence antibody/antigen IVD	A microplate or test strip of protein-activated wells intended to be used in immunohaematological testing of a clinical specimen for the detection and/or identification of red blood cell antibodies or antigens, using a solid-phase red blood cell adherence method.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10888234001317	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 1 – 30 Degrees Celsius