BinaxNOW RSV Control Swab Kit

GUDID 10811877011207

Control Swabs intended for use only with BinaxNOW RSV products.

Alere Scarborough, Inc.

Respiratory syncytial virus (RSV) antigen IVD, control

• Primary Device ID: 10811877011207
• NIH Device Record Key: 3c2db117-6bd2-49e1-829f-404977dab227
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BinaxNOW RSV Control Swab Kit
• Version Model Number: 430-080
• 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: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	10811877011207 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K032166

FDA Product Code

• GQG: Antigen, Cf (Including Cf Controls), Respiratory Syncytial Virus

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: 2020-09-24
• Device Publish Date: 2020-09-16

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