Capture-P

Basic Information

• Brand Name: Capture-P
• Primary DI: 10888234001560
• Version / Model: 0066904
• Catalog Number: 0066904
• Company Name: IMMUCOR, INC.
• Labeler DUNS: 061446282
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-09-03
• Public Version: 1
• Public Version Date: 2022-09-12
• Public Version Status: New
• Public Device Record Key: 3c5aca58-5ed4-4391-8dff-a2d3147782ba

Device Description

Capture-P Solid Phase System is intended for use in the detection of antibodies to platelets. Capture-P Solid Phase System is designed to detect the unexpected antiplatelet antibodies (antibody screening test) in a patient or donor population.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• 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

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KSS	Supplies, Blood-Bank	Hematology	864.9050	1

GMDN Terms

Code	Name	Definition	Implantable	Status
56576	Human platelet antigen (HPA) multiple antibody screening/identification IVD, kit, agglutination	A collection of reagents and other associated materials intended to be used in screening and/or identification of one or multiple antibodies to human platelet antigen (HPA) systems, which may include HPA-1, HPA-2, HPA-3, HPA-4, HPA-5 and/or HPA-15, in a clinical specimen using an agglutination method.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10888234001560	GS1

Premarket Submissions

Submission Number	Supplement Number
BK880022	0