Capture-P 0066904

GUDID 10888234001560

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.

IMMUCOR, INC.

Human platelet antigen (HPA) multiple antibody screening/identification IVD, kit, agglutination

• Primary Device ID: 10888234001560
• NIH Device Record Key: 3c5aca58-5ed4-4391-8dff-a2d3147782ba
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Capture-P
• Version Model Number: 0066904
• Catalog Number: 0066904
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	10888234001560 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• BK880022

FDA Product Code

• KSS: Supplies, Blood-Bank

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-09-12
• Device Publish Date: 2022-09-03

On-Brand Devices [Capture-P]

• 10888234001300: Capture-P solid phase system is intended for use in the detection of antibodies to platelets. Th
• 10888234001270: Capture-P solid phase system is intended for use in the detection of antibodies to platelets. Th
• 10888234001560: Capture-P Solid Phase System is intended for use in the detection of antibodies to platelets. Ca