Acceava®

GUDID 10815845020031

ALERE SAN DIEGO, INC.

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• Primary Device ID: 10815845020031
• NIH Device Record Key: 53193335-1dbf-40ac-89ba-1d03712dc4c3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Acceava®
• Version Model Number: 92001
• Company DUNS: 194854949
• Company Name: ALERE SAN DIEGO, INC.
• Device Count: 50
• 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	00815845020034 [Unit of Use]
GS1	10815845020031 [Primary]

FDA Product Code

• GTY: Antigens, All Groups, Streptococcus Spp.

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: 2022-06-10
• Device Publish Date: 2016-09-24

On-Brand Devices [Acceava®]

• 10815845020031: 92001
• 10815845020017: 92404