Capture-CMV Control set 0066239

GUDID 10888234001249

The Capture-CMV Control set is composed of both negative and weak positive control material to control the Capture-CMV test.

IMMUCOR, INC.

Cytomegalovirus (CMV) antigen IVD, reagent

• Primary Device ID: 10888234001249
• NIH Device Record Key: 835bd600-b11c-4fe0-9e04-8e66fc9e36ff
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Capture-CMV Control set
• Version Model Number: 0066239
• Catalog Number: 0066239
• 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: true
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 1-855-466-8267
• Email: tech_support@immucor.com

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	10888234001249 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K910003

FDA Product Code

• LJO: Antigen, Iha, Cytomegalovirus

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-04-14

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.