Capture-R Ready-Screen 3 0066901

GUDID 10888234001539

Capture-R Ready-Screen (3) 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.

IMMUCOR, INC.

Solid-phase red blood cell adherence antibody/antigen IVD Solid-phase red blood cell adherence antibody/antigen IVD Solid-phase red blood cell adherence antibody/antigen IVD Solid-phase red blood cell adherence antibody/antigen IVD Solid-phase red blood cell adherence antibody/antigen IVD Solid-phase red blood cell adherence antibody/antigen IVD Solid-phase red blood cell adherence antibody/antigen IVD Solid-phase red blood cell adherence antibody/antigen IVD Solid-phase red blood cell adherence antibody/antigen IVD Solid-phase red blood cell adherence antibody/antigen IVD Solid-phase red blood cell adherence antibody/antigen IVD

• Primary Device ID: 10888234001539
• NIH Device Record Key: 3db96cb6-100b-4972-9e52-152ef796c200
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Capture-R Ready-Screen 3
• Version Model Number: 0066901
• Catalog Number: 0066901
• 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	10888234001539 [Primary]

FDA Product Code

• QHT: Reagent Red Blood Cells

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: 2022-08-09
• Device Publish Date: 2022-08-01

Devices Manufactured by IMMUCOR, INC.

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• 10888234001553 - Capture-R Select: 2022-09-12 The Capture-R Select Solid Phase System provides modified microwells for the immobilization of human erythrocytes for use in sol
• 10888234001560 - Capture-P: 2022-09-12 Capture-P Solid Phase System is intended for use in the detection of antibodies to platelets. Capture-P Solid Phase System is de
• 10888234001577 - Capture-P Positive Control Serum (Weak), Capture-P Negative Control Serum: 2022-09-12 Immucor’s Capture-P Positive Control Serum (Weak) and Capture-P Negative Control Serum are run controls to be used in the Capt
• 10888234002291 - Capture LISS: 2022-09-12 Capture LISS is a low ionic solution containing glycine and the dye Bromocresol Purple and the preservative sodium azide (0.1%).
• 10888234002307 - Capture-R Ready Indicator Red Cells: 2022-09-12 Anti-IgG-coated Indicator Red Cells for use in Capture-R Ready-Screen, Capture-R Ready-ID or Capture-R Select Solid Phase Assays
• 10888234002314 - Capture-P Indicator Red Cells: 2022-09-12 Anti-IgG coated Indicator Red Cells are intended for use in Capture-P and Capture-P Ready-Screen solid phase assays for the dete
• 10888234001522 - Referencells: 2022-08-11 Referencells (Pooled Cells) are intended for use in tube and microplate ABO serum grouping tests.