Capture-P Indicator Red Cells 0066906

GUDID 10888234002314

Anti-IgG coated Indicator Red Cells are intended for use in Capture-P and Capture-P Ready-Screen solid phase assays for the detection of IgG antibodies to platelets. Capture-P Indicator Red Cells are a suspension of red blood cells coated with rabbit anti-human IgG. The red blood cells are suspended in a buffered preservative solution to which chloramphenicol (0.25 mg/mL) , neomycin sulfate (0.1 mg/mL) and gentamycin sulfate (0.05 mg/mL) have been added as preservatives.

IMMUCOR, INC.

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• Primary Device ID: 10888234002314
• NIH Device Record Key: 16b5aeba-9726-44a1-b386-ff75af0474f5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Capture-P Indicator Red Cells
• Version Model Number: 0066906
• Catalog Number: 0066906
• 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	10888234002314 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• BK860017

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 Indicator Red Cells]

• 10888234001256: Capture-P Indicator Red Cells are part of both the Capture-P and Capture-P Ready-Screen tests, a
• 10888234002314: Anti-IgG coated Indicator Red Cells are intended for use in Capture-P and Capture-P Ready-Screen