Alere i Influenza A & B 2

GUDID 10811877010019

A rapid, automated, molecular test for the qualitative detection of influenza A and B viral nucleic acid in respiratory specimens.

Alere Scarborough, Inc.

Influenza A/B virus nucleic acid IVD, kit, nucleic acid technique (NAT)

• Primary Device ID: 10811877010019
• NIH Device Record Key: 920d9dfd-8f57-4a5c-8cf8-395d7ef7d8bf
• Commercial Distribution Discontinuation: 2019-10-23
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Alere i Influenza A & B 2
• Version Model Number: 427-000
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	10811877010019 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K171792

FDA Product Code

• OCC: Respiratory Virus Panel Nucleic Acid Assay System

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: 2023-09-12
• Device Publish Date: 2017-11-20

Devices Manufactured by Alere Scarborough, Inc.

• 00811877012030 - BinaxNOW COVID-19/Flu A&B Combo Self Test: 2025-02-07 Intended for detection of proteins from Influenza A, Influenza B and SARS-CoV-2, not for any other viruses or pathogens
• 00811877012047 - BinaxNOW COVID-19/Flu A&B Combo Self Test: 2025-02-07 Intended for detection of proteins from Influenza A, Influenza B and SARS-CoV-2, not for any other viruses or pathogens
• 00811877012054 - BinaxNOW COVID-19/Flu A&B Combo Self Test: 2025-02-07 Intended for detection of proteins from Influenza A, Influenza B and SARS-CoV-2, not for any other viruses or pathogens
• 00811877012061 - BinaxNOW COVID-19/Flu A&B Combo Self Test: 2025-02-07 Intended for detection of proteins from Influenza A, Influenza B and SARS-CoV-2, not for any other viruses or pathogens
• 00811877012078 - BinaxNOW COVID-19/Flu A&B Combo Self Test: 2025-02-07 Intended for detection of proteins from Influenza A, Influenza B and SARS-CoV-2, not for any other viruses or pathogens
• 00811877012085 - BinaxNOW COVID-19/Flu A&B Combo Self Test: 2025-02-07 Intended for detection of proteins from Influenza A, Influenza B and SARS-CoV-2, not for any other viruses or pathogens
• 00811877012092 - BinaxNOW COVID-19/Flu A&B: 2025-02-07 Intended for detection of proteins from Influenza A, Influenza B and SARS-CoV-2, not for any other viruses or pathogens
• 00811877012108 - BinaxNOW COVID-19/Flu A&B Controls: 2025-02-07 Intended for detection of proteins from Influenza A, Influenza B and SARS-CoV-2, not for any other viruses or pathogens