Capture-R Positive Control Serum (Weak), Capture-R Negative Control Serum 0066902

GUDID 10888234001546

Immucor’s Capture-R Positive Control Serum (Weak) and Capture-R Negative Control Serum are run controls to be used in Capture-R Solid Phase Assays, including Capture-R Select, Capture-R Ready-Screen and Capture-R Ready-ID. Capture-R Positive Control Serum (Weak) contains antibodies to red blood cells and sodium azide added as a preservative. Capture-R Negative Control Serum contains no antibodies to red blood cells; sodium azide is added as a preservative.

IMMUCOR, INC.

Total immunoglobulin G (IgG total) IVD, control

• Primary Device ID: 10888234001546
• NIH Device Record Key: 33b72fcc-5af1-497a-b068-bd48fe5014b6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Capture-R Positive Control Serum (Weak), Capture-R Negative Control Serum
• Version Model Number: 0066902
• Catalog Number: 0066902
• 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: true
• 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

Operating and Storage Conditions

• Handling Environment Temperature: Between 1 Degrees Celsius and 10 Degrees Celsius
• Handling Environment Temperature: Between 1 Degrees Celsius and 10 Degrees Celsius
• Handling Environment Temperature: Between 1 Degrees Celsius and 10 Degrees Celsius
• Handling Environment Temperature: Between 1 Degrees Celsius and 10 Degrees Celsius
• Handling Environment Temperature: Between 1 Degrees Celsius and 10 Degrees Celsius
• Handling Environment Temperature: Between 1 Degrees Celsius and 10 Degrees Celsius
• Handling Environment Temperature: Between 1 Degrees Celsius and 10 Degrees Celsius
• Handling Environment Temperature: Between 1 Degrees Celsius and 10 Degrees Celsius
• Handling Environment Temperature: Between 1 Degrees Celsius and 10 Degrees Celsius
• Handling Environment Temperature: Between 1 Degrees Celsius and 10 Degrees Celsius
• Handling Environment Temperature: Between 1 Degrees Celsius and 10 Degrees Celsius
• Handling Environment Temperature: Between 1 Degrees Celsius and 10 Degrees Celsius
• Handling Environment Temperature: Between 1 Degrees Celsius and 10 Degrees Celsius
• Handling Environment Temperature: Between 1 Degrees Celsius and 10 Degrees Celsius
• Handling Environment Temperature: Between 1 Degrees Celsius and 10 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	10888234001546 [Primary]

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

Devices Manufactured by IMMUCOR, INC.

• 10888234001546 - Capture-R Positive Control Serum (Weak), Capture-R Negative Control Serum: 2022-09-12Immucor’s Capture-R Positive Control Serum (Weak) and Capture-R Negative Control Serum are run controls to be used in Capture-R Solid Phase Assays, including Capture-R Select, Capture-R Ready-Screen and Capture-R Ready-ID. Capture-R Positive Control Serum (Weak) contains antibodies to red blood cells and sodium azide added as a preservative. Capture-R Negative Control Serum contains no antibodies to red blood cells; sodium azide is added as a preservative.
• 10888234001546 - Capture-R Positive Control Serum (Weak), Capture-R Negative Control Serum: 2022-09-12 Immucor’s Capture-R Positive Control Serum (Weak) and Capture-R Negative Control Serum are run controls to be used in Capture-
• 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.