BinaxNOW COVID-19 Antigen Self Test

GUDID 00811877011705

A rapid test for the qualitative detection of COVID-19 antigens in nasal swab specimens.

Alere Scarborough, Inc.

SARS-CoV-2 antigen IVD, kit, rapid ICT, self-testing

• Primary Device ID: 00811877011705
• NIH Device Record Key: 08ee1404-40b0-498e-ac91-3890535d9068
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BinaxNOW COVID-19 Antigen Self Test
• Version Model Number: 195-268
• 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	00811877011705 [Primary]

FDA Product Code

• QKP: Coronavirus Antigen Detection Test System.

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: 2022-08-15
• Device Publish Date: 2022-08-05

On-Brand Devices [BinaxNOW COVID-19 Antigen Self Test]

• 00811877011460: A rapid test for the qualitative detection of COVID-19 antigens in nasal swab specimens.
• 00811877011453: A rapid test for the qualitative detection of COVID-19 antigens in nasal swab specimens.
• 00811877011446: A rapid test for the qualitative detection of COVID-19 antigens in nasal swab specimens.
• 00811877011415: A rapid test for the qualitative detection of COVID-19 antigens in nasal swab specimens.
• 00811877011408: A rapid test for the qualitative detection of COVID-19 antigens in nasal swab specimens.
• 00811877011521: A rapid test for the qualitative detection of COVID-19 antigens in nasal swab specimens.
• 00811877011712: A rapid test for the qualitative detection of COVID-19 antigens in nasal swab specimens.
• 00811877011705: A rapid test for the qualitative detection of COVID-19 antigens in nasal swab specimens.
• 00811877011699: A rapid test for the qualitative detection of COVID-19 antigens in nasal swab specimens.
• 00811877011682: A rapid test for the qualitative detection of COVID-19 antigens in nasal swab specimens.
• 00811877011675: A rapid test for the qualitative detection of COVID-19 antigens in nasal swab specimens.
• 00811877011736: A rapid test for the qualitative detection of COVID-19 antigens in nasal swab specimens.
• 00811877011729: A rapid test for the qualitative detection of COVID-19 antigens in nasal swab specimens.
• 00811877011514: A rapid test for the qualitative detection of COVID-19 antigens in nasal swab specimens.
• 00811877011118: A rapid test for the qualitative detection of COVID-19 antigens in nasal swab specimens.
• 00811877011798: A rapid test for the qualitative detection of COVID-19 antigens in nasal swab specimens.
• 00811877011507: A rapid test for the qualitative detection of COVID-19 antigens in nasal swab specimens.
• 00811877011477: A rapid test for the qualitative detection of COVID-19 antigens in nasal swab specimens.