Signify®

GUDID 10815845020062

ALERE SAN DIEGO, INC.

Epstein-Barr virus (EBV) heterophile antibody IVD, kit, rapid ICT, clinical

• Primary Device ID: 10815845020062
• NIH Device Record Key: 658b227b-3dec-4886-803b-d376131f74ac
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Signify®
• Version Model Number: 01P52-25
• Company DUNS: 194854949
• Company Name: ALERE SAN DIEGO, INC.
• Device Count: 25
• 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

Customer Support Contacts

• Phone: (866) 216-0094
• Email: xx@xx.xx
• Phone: (866) 216-0094
• Email: xx@xx.xx
• Phone: (866) 216-0094
• Email: xx@xx.xx
• Phone: (866) 216-0094
• Email: xx@xx.xx
• Phone: (866) 216-0094
• Email: xx@xx.xx
• Phone: (866) 216-0094
• Email: xx@xx.xx

Device Identifiers

Device Issuing Agency	Device ID
GS1	00815845020065 [Unit of Use]
GS1	10815845020062 [Primary]

FDA Product Code

• KTN: System, Test, Infectious Mononucleosis

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2022-06-10
• Device Publish Date: 2016-09-24

On-Brand Devices [Signify®]

• 10815845020086: 01P48-25
• 10815845020062: 01P52-25
• 10815845020055: 01P46-50
• 10815845020079: 01P53-25