BinaxNOW COVID-19/Flu A&B Combo Self Test

GUDID 00811877012085

Intended for detection of proteins from Influenza A, Influenza B and SARS-CoV-2, not for any other viruses or pathogens

Alere Scarborough, Inc.

Multiple-genus respiratory virus antigen IVD, kit, rapid ICT, self-testing

• Primary Device ID: 00811877012085
• NIH Device Record Key: 518f71a9-7339-4e74-ac36-c2c597d698db
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BinaxNOW COVID-19/Flu A&B Combo Self Test
• Version Model Number: 20002058
• Company DUNS: 154148498
• Company Name: Alere Scarborough, 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: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00811877012085 [Primary]

FDA Product Code

• SCA: Multi-Analyte Respiratory Virus Antigen Detection Test

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-02-07
• Device Publish Date: 2025-01-30

On-Brand Devices [BinaxNOW COVID-19/Flu A&B Combo Self Test]

• 00811877012146: Intended for detection of proteins from Influenza A, Influenza B and SARS-CoV-2, not for any oth
• 00811877012139: Intended for detection of proteins from Influenza A, Influenza B and SARS-CoV-2, not for any oth
• 00811877012122: Intended for detection of proteins from Influenza A, Influenza B and SARS-CoV-2, not for any oth
• 00811877012115: Intended for detection of proteins from Influenza A, Influenza B and SARS-CoV-2, not for any oth
• 00811877012085: Intended for detection of proteins from Influenza A, Influenza B and SARS-CoV-2, not for any oth
• 00811877012078: Intended for detection of proteins from Influenza A, Influenza B and SARS-CoV-2, not for any oth
• 00811877012061: Intended for detection of proteins from Influenza A, Influenza B and SARS-CoV-2, not for any oth
• 00811877012054: Intended for detection of proteins from Influenza A, Influenza B and SARS-CoV-2, not for any oth
• 00811877012047: Intended for detection of proteins from Influenza A, Influenza B and SARS-CoV-2, not for any oth
• 00811877012030: Intended for detection of proteins from Influenza A, Influenza B and SARS-CoV-2, not for any oth