Acceava® Mono Cassette

GUDID 10859035006238

ALERE NORTH AMERICA, LLC

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

• Primary Device ID: 10859035006238
• NIH Device Record Key: 81cbc70c-5244-4901-8050-0a08c89de51f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Acceava® Mono Cassette
• Version Model Number: 92407
• Company DUNS: 826027364
• Company Name: ALERE NORTH AMERICA, LLC
• Device Count: 25
• DM Exempt: false
• Pre-market Exempt: true
• 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 1-877-441-7440
• Email: ts.scr@alere.com
• Phone: 1-877-441-7440
• Email: ts.scr@alere.com
• Phone: 1-877-441-7440
• Email: ts.scr@alere.com
• Phone: 1-877-441-7440
• Email: ts.scr@alere.com
• Phone: 1-877-441-7440
• Email: ts.scr@alere.com
• Phone: 1-877-441-7440
• Email: ts.scr@alere.com

Operating and Storage Conditions

• Handling Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00859035006231 [Unit of Use]
GS1	10859035006238 [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

Devices Manufactured by ALERE NORTH AMERICA, LLC

• 10859035006023 - DENCOCCULT™ III: 2022-11-28
• 10859035006016 - IMMUNEX CRP®: 2022-06-10
• 10859035006238 - Acceava® Mono Cassette: 2022-06-10
• 10859035006238 - Acceava® Mono Cassette: 2022-06-10