Capture-CMV 0066216

GUDID 10888234002154

Capture-CMV is an in vitro qualitative solid phase red cell adherence test system for the detection of antibodies (IgG plus IgM) to cytomegalovirus (C

IMMUCOR, INC.

Cytomegalovirus (CMV) antigen IVD, reagent

• Primary Device ID: 10888234002154
• NIH Device Record Key: a74dfbdc-9a50-4b02-a6dc-c9f403fef8e2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Capture-CMV
• Version Model Number: 0066216
• Catalog Number: 0066216
• 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: 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 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	10888234002154 [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

On-Brand Devices [Capture-CMV]

• 10888234002154: Capture-CMV is an in vitro qualitative solid phase red cell adherence test system for the detect
• 10888234001157: Capture-CMV is an in vitro qualitative solid phase red cell adherence test system for the detect