Capture-R Ready-Screen (Pooled Cells)

Basic Information

• Brand Name: Capture-R Ready-Screen (Pooled Cells)
• Primary DI: 10888234001942
• Version / Model: 0006433
• Catalog Number: 0006433
• 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: 0a24bc90-8e64-410f-9b72-c9b42d279277

Device Description

Capture-R Ready-Screen (Pooled Cells) is intended for use in the detection of unexpected IgG antibodies to red blood cells by manual, semi-automated or automated solid phase red blood cell adherence methods. Each well is coated with red blood cell membranes prepared from a pool suspension of equal proportions of red blood cells from two Group O donors. Each strip consists of eight (8) individual wells to perform eight (8) antibody screens.

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	10888234001942	GS1

Customer Contacts

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

Storage Conditions

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